Posts in regulation compliance

How to Succeed in the Automotive Industry?

January 19th, 2020 Posted by ASPICE, Automotive, Requirements Management Tool 0 thoughts on “How to Succeed in the Automotive Industry?”

What does it take to succeed in the Automotive Industry? Well, the majority of the stakeholders in the industry agree that success comes with product quality. It is hard to argue the impact that product quality plays in automotive success. Likewise, evidence from surveys shows that when it comes to success and profitability in the world of automotive. Product Quality ranks above other factors.

The Industry Demands Product Excellence Ask people in the Automotive industry what leads to success and you’ll hear that product quality has a major impact. As you might expect, survey respondents report product quality as a profitability and success driver more frequently than any other factor. 

But innovation reported as a profitability driver more frequently by Automotive companies than any other industry in our survey isn’t far behind. Perhaps this isn’t surprising given the major changes facing the industry. 

The top success factors – quality, innovation, reliability, performance, and cost – are all related to product excellence. But today’s dynamic market also demands agility. In fact, OEM’s were almost twice as likely as suppliers to report time-to-market as a critical success driver. 

The ALM & QMS, Together, Delivers Product Excellence and Agility Our research shows that an effective ALM & QMS can help improve all of these factors. These platforms, incorporating engineering tools (ALM) and QMS capabilities, are proven to drive better product development results. The cloud is reducing the barriers between these ALM & QMS solutions and provides benefits in multiple dimensions, including affordability, flexibility, and agility. We explore these further in the research. 

Most Important Factors to Automotive Industry Success & Profitability

Success Rate


If you are looking to leverage on the factors that will drive your company to success. Reach out to us at Orcanos and we will show you how to enhance your product while reducing the cost. After working with us, you can be sure that you will be a symbol of innovation in the automotive market.


  • Product Quality is vital to the success of an automotive company
  • The factors to success in the industry can be summarized as agility and product excellence.
  • ALM and QMS tools will allow companies to achieve product excellence.
  • The cloud makes ALM and QMS tools easy and affordable to use.
  • Orcanos is the company to meet for help with how to leverage cloud and


CAPA Chapter II – Driving Source

September 21st, 2019 Posted by e-GMP, ISO 13485, Recall 0 thoughts on “CAPA Chapter II – Driving Source”

Often times, we suspect products and process as the main sources for CAPA. However, there are several other areas that we can consider as CAPA sources. They include;

  • Customer Complaints: It represents a majorly of all product-related sources for CAPA.  In the event that the customer complaints are repetitive, then there is a chance that the root cause can keep recurring. Also, complaints about the system are an indication that there is a problem with the training or instruction.
  • Yield Rates: Yields rates are most likely the main cause of CAPA rising in the manufacturing industry. Systemic issues become unavoidable when there are frequent expulsions in the process limit.
  • External and Internal Audits: Audits are the biggest identifiers that there should be a process PA or CA in the system.
  • Employee Feedback: The feedback from employees could help prevent process issues as well as enhance product development in the future.  Employee feedback is one of the direct sources a company can use to implement CAPA.
  • Vigilance: Another great resource for CAPA is to remain abreast of competitors in the same field. You can study your competitor’s product to try and implement steps to prevent certain likely problems that may arise in your product. For example, you learned that pumps develop a free flow problem by studying your competitor’s pumps. You can hereby take steps to eliminate the problem in your own pumps. We at Orcanos conduct daily research on every recall that is reported by the FDA site and conducts a technical analysis to allow the share of such events with our customers.

Managing Risks

Subconsciously most people find themselves managing risk by prioritizing their daily tasks and giving more effort to tasks they consider more important. Similarly, CAPA requires the same approach.  The actions to be taken should be prioritized based on risks. The reasons to apply such a strategy are;

  1.  To prevent the company from wasting resources on trivial problems.
  2.  To continue to create an opportunity to respond to public safety concerns.
  3.  The risk will help determine the approach of the investigation. For instance, you could take a scientific approach like the FMEA or FTA when dealing with patients safety. Meanwhile, a five-why approach can be used to address process issues.
  4. Always document your risk-based decisions.

The Process

In taking a closer look into the CAPA process, we will be expanding on the key requirements. They include;

  • Analysis
  • Investigation
  • Determining action
  • Implementing action
  • Determining the Effectiveness

First Thing to Consider: Understand

The step in the CAPA process is understanding. Without understanding the issue, it will be impossible to find the root causes or determine appropriate action. In the event that you do implement appropriate actions, there is a chance that actions and the changes would not be as comprehensive as they ought to be.

However, there are steps to take in order to understand the problem. The steps include;

  1. Defining the problem as well as writing it down. In so doing, you can better grasp the starting point of the issue.
  2. Try to identify the cause of the problem. A simple tool to use is the Fishbone Diagram.
  3. Using the Fishbone Diagram you have to determine if people, machinery, environment, process, material, and management are contributing to the problem. While you might not be solving the problem at this stage, you will be gaining a better understanding.
  4. The scope of the problem is the next step in the process.  For instance, perhaps you are using a piece of particular equipment to manufacture several parts. Unfortunately, there seems to be a fault with just one part.

Regardless of the fact that the other parts created using the same equipment have no faults, you should consider the possibility that the equipment could be contributing. Likewise, there could be a documentation problem. The ability to analyze scope ensures that you identify all the root causes.

In the event that a problem escapes detection, then it is important that there be an investigation as to why it wasn’t detected.  Perhaps there were no early-stage checks or the current checks are ineffective. 

The importance of early-stage checks is vital in the software industry where late-stage errors can prove to be costly. For example, an error that is not fixed in design stage can be 3 times or more expensive to fix at the verification stage of the process. Therefore, best to think of the early stages where the problems could be fixed and document them.


When you discover a non-conformity in a product, then it is time to exercise damage control. The damage control is not to divert the financial burden, but to ensure that the product does not cause harm to patients. If the product is already in the market then issuing a call-back and inform the customers to prevent more damage is the best course of action. 

However, if the product is still in the inventory, then the containment action will be to quarantine the inventory until the problem is solved. Containment actions should always match the risk as the damage control for issues that will affect customer’s health will differ from actions that have to deal will function or form.

Scope Analysis

Below is the summary of the thought that should go into scope analysis.

  1.  If a product is affected by equipment, then what other products are affected by the same equipment?
  2.  How thorough is your quality control system if a process is missing a particular document?
  3.  Are there audit gaps or any other gaps?
  4.  Are all of your software system validated? Is your validation process complete?
  5.  Do components affect the quality of your system and what role does your supplier play?

In conclusion, if you do not fully comprehend the extent of a problem in the CAPA system, then there is bound to be some missteps along the way.

10 Tips on How To Keep Your Good Manufacturing Practice and Making GMP At Top

July 29th, 2019 Posted by e-GMP, Software Lifecycle Management 0 thoughts on “10 Tips on How To Keep Your Good Manufacturing Practice and Making GMP At Top”


GMP is all about manufacturing safe, and high product quality.

On a recent audit I participated in, for one of our customers, the auditor stated the tremendous effort small companies will have to invest in order to meet regulatory compliance in the next 2-5 years.

It was mind-blowing and drove me to write this article, and share with you some tips on how to keep your GMP at the top.

What is GMP

The GMP establishes minimum standards for product manufacturing, to assist in preventing adulteration. But more importantly, GMP needs to be a so-called “lifestyle” that each company clearly defines and implements through its quality systems, in order to protect the safety of its customers.

The 10 principles of the GMP

These are 10 principles of good manufacturing principles that I believe can help in achieving a “GMP lifestyle” in your organization.

1)    Writing step-by-step procedures and work instructions

2)   Carefully following written procedures and instructions to prevent contamination, mix-up, and errors. [Many recalls on these topics were issued during 2019].

3)   Promptly and accurately document work using Document Management System preferred electronic DMS for a better tacking, sign-off and traceability [You can read here about Orcanos Document Management System]

4)   Providing evidence that our QMS does what it is designed to do by validating our work by preparing a [master validation plan]

5)   Integrating productivity, product quality, and employee safety into the design and construction of our facilities and equipment.

6)   Properly maintaining our facilities and equipment.

7)   Clearly defining and demonstrating job confidence.

8)   Protecting our products against contamination, by making cleanliness and hygiene a daily habit.

9)   Building quality into our product by systematically controlling our components and product-related processes, such as manufacturing, packaging, labeling, testing, distribution, and marketing.

10)   Conducting planned and periodic audits for compliance and performance [Learn about Orcanos Audit Management System].


These 10 principles of GMP, provide us with a framework for building and maintaining a GMP lifestyle and help us evaluate how well we are complying with the standards of good manufacturing practices.

Procedures and working instructions

The first two GMP principles stress the importance of written procedures. The best way to comply with GMP is to have well-written procedures and to carefully follow them.

The heart of GMP is the establishment of well-written procedures for each operation. These written procedures give us the controls necessary to minimize the chance of mix-ups and errors in manufacturing a product. When we carefully follow our written procedures, we not only ensure compliance with the GMP regulation but more importantly, we ensure the consistent quality of our products.

Fig 1: Manage a CAPA in Orcanos eQMS™

Validating our work

The next two GMP principles stress the need for us to document and validate our work. Because documentation and validation are so important to us and to our company, let’s look at them more closely.


We may begin by asking, what does documentation really mean, in terms of our job performance? Well, documentation requires a specific action on our part. The recording of each significant step we perform as we perform a job task. Documentation should be made properly and accurately, and in accordance with our written procedures.


As important as documentation is, it shows only that we have carefully and exactly followed our written procedures. Validation is proactive proof that we can produce safe and effective products. Validation requires a series of tests to assure that our systems and processes do what we say they do. We must be sure our production processes consistently meet the specifications our company has established. Therefore validation gives meaning to the documented records we keep. It is validation that tells us that our written procedures are correct, and that our products are truly safe and effective.

Facilities and equipment management

GMP principles fifth and sixth focus on the design, construction, and maintenance of our facilities and equipment. Let’s take a look at how GMP relates to the place where we work, and the equipment we use.


Our key concern is to avoid the possibility of contamination, mix-up, and errors in our workplace. For example, we keep certain areas, the cafeteria, locker room, and washrooms, separated from the manufacturing area. Where necessary to protect the integrity of our products, we carefully control water, air, temperature, and humidity. Housekeeping, sanitation, and maintenance also work to defend against contamination, mix-ups, and errors.

The right people

The seventh GMP principle states that good manufacturing practice requires competent people. People who can do the job right, the first time and every time. That means it is our personal responsibility to develop, demonstrate and continuously improve our job competence.

In order to do any job well, we must be properly trained; and this is particularly true in the manufacturing and quality control areas. In fact, our company must have a formal training program, to ensure that each employee can competently perform assigned job responsibilities. And that leads to our eighth GMP principle, which focuses on cleanliness, and requires us to be constantly on guard to defend our products against contamination.

Fig 3: Example of a training program template


Contamination can be a powerful and dangerous enemy, which takes on many different forms. One of the most common forms is Particulate Contamination. This simply means that a product has been made impure by any particle that doesn’t belong in it. For example, dust, lint, fibers, and hair are all potential causes of Particulate Contamination. That is why, we must be properly dressed to prevent contamination when working with our materials, component, and products.

The second kind of contamination is Microbial Contamination. This is caused by microscopic organisms, known as microbes. Microbes are living organisms that exist one everything in the environment that has not been sterilized. Microbes include fungus,  mold, bacteria, and viruses.

The third form of contamination is Cross Contamination. Cross Contamination occurs when traces of other materials’ components and products adulterate or mis-brand the products we are currently manufacturing, packaging or testing. So it is critical that we practice good personal hygiene, and help keep our workplace clean by reporting any condition or practice in our plant, or with our equipment that might be a potential source of Particulate, Microbial or Cross Contamination.

Quality Management

The ninth GMP principle focused our attention on the importance of building quality into our products, by systematically controlling our components and product-related processes. To see how GMP helps us build quality, let’s examine the critical areas where we must establish effective controls. Materials and components present the first critical control challenge. We must be sure all of our components and materials satisfy our quality standards. Upon receipt, they must be carefully examined for damage and contamination, properly identified and tagged, and stored in a quarantine area. Where required, certain components and materials must be sampled and tested to ensure they meet established standards of identity, quality, and purity. Only after approval is they released to manufacturing and used on a first-in-first-out basis. That is, the first materials and components approved for release, are the first to go to manufacturing.

The second critical area we must control is the manufacturing process itself. To ensure quality and uniformity of each product, we have master records that outline the specifications and manufacturing procedures, and individual batch or history records (E-DHR) to help us document our conformance to the master record, and written schedules and procedures for cleaning and maintaining our equipment. To help us operate in a state of control, we carefully follow written work instructions, accurately collect critical data, and promptly document manufacturing results.

Fig 4: Production ATE Results Online Collection (GMP)

Fig 4: Production ATE Results Online Collection using Orcanos Rest API

Packaging and labeling is the third critical area where we control for quality. We must inspect the packaging and labeling area before each new batch or lot is processed; to help us be certain that the packaging equipment is clean and that the area does not contain any packaging or labeling materials from a previous run.


The fourth critical area is testing and supports all other areas of control. How we handle incoming, in-process and finished product test samples, how we perform test methods, how we document test results, are all significant elements of the testing process, and must be performed by qualified individuals.

Fig 5: Test Protocols Results using QPack Test Management™

Fig 5: Test Protocols Results using Orcanos Test Management™


The final critical area of control focuses on how we assure the safety, effectiveness, and purity of our product, as they enter the marketplace. The challenge to control the quality does not end when the finished product is tested and released. We must carefully control the product as we warehouse and distribute it to our customers. We must closely monitor the sales and marketing strategies we use to interact with our customers, and we must keep accurate records to provide product traceability, and promptly respond to any customer problems, concerns or complaints.

Fig 6: Follow Up Global Activity on Service Call using QPack Service Center

Fig 6: Follow Up Global Activity on Service Call using Orcanos Service Center


The tenth and final GMP principle entail the need to continually audit our day-to-day job performance, and verify that we are in compliance with the GMP regulation. The FDA has a major responsibility to externally audit our manufacturing operations, to see if we are in compliance with the GMP regulation. But it is our company’s responsibility to internally ensure the integrity of our products. And most importantly, it is our personal responsibility to evaluate how well we are living up to the standards of GMP. By performing a self-audit, using the 10 principles of GMP, you can make GMP a daily lifestyle in our company, and not just regulation.

Fig 7: Proactive Pre-Audit Reports/Alerts using QPack Reporting Tools

Fig 7: Proactive Pre-Audit Reports/Alerts using Orcanos Reporting Tools


In addition to our responsibilities to our customers, the FDA also has a responsibility to protect the consumer. In fact, the FDA can recommend a recall, if they find one of our products contaminated, mislabeled or if our product is not manufactured in compliance with the current GMP regulation.


So it is extremely important that we carefully follow the 10 principles of GMP. At our company, we are all concerned about what we do, and how we do it. This concern for quality, helps us earn the trust of millions of people who use our products. It is our job to make GMP a lifestyle, and live the principles of GMP each and every day.

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cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016

June 17th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Medical Equipment Calibration – How it affect our success – ISO 13485:2016”

Calibration is considered as an essential procedure for any equipment and device, in order to maintain and improve its accuracy and precision. Calibration is the process, in which equipment under test is compared with some other standard equipment, in order to understand the accuracy of the one being produced. The calibration of medical equipment is also based on the same principle.

Medical equipment calibration is essential to the success of the product, the demand for calibration planning system is increasing, owing to various factors, such as rising number of hospitals, increasing environmental regulations, and rising customer focus towards quality and precision. The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Medical device calibration has two sections, the service types, and the equipment types. The equipment types have a market in the following segments;


  • Infusion pumps
  • Fetal monitors
  • Ventilators
  • Imaging equipment
  • Vital sign monitors
  • Cardiovascular monitors etc.


Meanwhile, the service types have three major markets namely;

  • In-house Calibration: The Professional personnel of the company will perform the calibration. The staffs are mainly from the production line.
  • Third Party Calibration Services: Other professionals outside the company will perform the calibration for a fee.
  • OEM Calibration Services: The owner of the service will need to set up plans and notification ahead of time.


Out of the all above devices, The medical device producers of imaging equipment requires calibration services are the largest demand. Although, there are expectations that cardiovascular monitors will keep growing at the highest growth rate to match demands.

Increasing focus of customers on the quality, rising growing need for more control on the calibration planning and documentation due to strict compliance environment which are key factors expected to drive the growth of this demand.

The critical factors in driving the demands for cardiovascular monitors include:

  1. Customers are focusing on quality.
  2. The need to control calibration planning.
  3. Strict compliance requires documentation.
  4. A rise in product recall.


Reports from the FDA in the US show that in the past decade, product recalls has grown from 763 to 3202 between 2009 and 2017.

These recalls were observed due to software design failure, component and material issues and packaging and labeling. Hence, such frequent product recall affects the company’s reputation and thus, the companies are offering a strong emphasis on the calibration of their products before and after commercialization.

This fact is considered as an important growth propeller of this demand by the medical device manufacturers market. In addition, rising demand for third party and in-house calibration services is another important driver for the need of calibration planning system such as Orcanos eQMS.

What could affect the implementation of Calibration system?

Some of the crucial factors include;

  • High Capital
  • The use of modular instrumentation
  • Regional and local companies dominating the market


Medical equipment calibration services are segmented in areas such as North America, Europe, Asia-Pacific and Rest of the World (RoW).

Presently, we see the European region is the largest market in the world, owing to extensive R&D practices by the industry, a large number of local and regional players and rapidly growing medical and healthcare infrastructure.

However, Asia-Pacific region is expected to be the fastest growing market during the forecast period 2019 – 2025. This growth is driven by rising demand for good quality services, steadily increasing medical infrastructure and rising government regulations.

The purpose of this article is to help identify both the current and future of calibration in the medical device market.

Orcanos provide for these players a greater potential by collaborating with the vendor directly over Orcanos eQMS cloud system to plan and execute the calibration program.

Some of the global service players include Fluke Biomedical, Tektronix, Inc., JPen Medical Ltd., NS Medical Systems and Biomed Technologies, Inc. amongst others. However, these companies have to face stiff competition from various players operating at the regional level and hence; collaboration or acquisition of cloud system is considered as an important strategy for the players to grow in this market.

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cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7

June 16th, 2019 Posted by e-GMP, Requirements Management, Validation and Verification 0 thoughts on “cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016 (8) Clause 7”

In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output.  The output will possess risk assessment for the following ;

  • Assembly drawings
  • The specification for raw materials and components
  • Design and process
  • Instruction for installation and service
  • Guideline for the assembly process
  • Specification for labeling and packaging
  • Source code and technical files
  • Biocompatibility studies
  • Results of verification activity
  • Validation activities such as sterility, reliability testing or shelf-life studies and shipping.


The design and development output is also known as the first realized product. Depending on the type of product. It could be the first of several lines of assemblies or the first batch of products manufactured. The initial set of the first realized product must undergo evaluation checks. The checks will ensure that the design output requirement is met. Likewise, there will be serial number checks to ensure there is consistency in the process.

Orcanos ALM provides all the tools you need for complete coverage of the design outputs both from the product definition but as well from the change control as risk management according to ISO 14971:2012 with full traceability and impacts analysis tools, all in the same tool.



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cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7

May 30th, 2019 Posted by e-GMP, Requirements Management, Standards and Regulations 0 thoughts on “cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7”

We expect that the Design & Development Plan be a written and reviewed document. Similarly, the Design Inputs also needs to be a controlled document. In practice, the design input document is created alongside the DDP simultaneously. However, before we start to analyze the design input, we should take a look at User Requirement Specifications (URS) or Customer Related Processes (see ISO 13485:2016 Chapter 7.2).

The focus of the URS should be on the customer experience. In other words, it should be a list of what the user desires rather than a list of requirements. Also, the list should not have solutions alongside it unless the solution satisfies the requirement of what the user wants to achieve using the product. Likewise, the URS should also include answers on what the customer experiences. In the medical device industry, the demands of the users should be considered from two perspectives namely;

  1.      As a patient.
  2.      As the device operator.

The moment the needs of the user is identified, the device designers have to translate those needs into the design input forms. Although the job is primarily that of the device engineer, inputs from crucial personnel in production, marketing, service, and others should be added as needed. Design engineers should strive to eliminate ambiguity in the design input process to reduce the level if inaccurate assumption. One of the effective ways to avoid false assumptions is to exclude design solutions from the design inputs unless the solution is part of the design. For example, let say a user requirement is; the device must have a foot switch to trigger operation. A suitable alternative would be not to specify a foot switch, rather have the requirement stipulate the need for a hand free operation for the device.

Design Input Categories

Using the User Requirement Specification, one can easily generate several input requirements documents. Input Requirements often fall into three categories namely;

  • The Functional Requirements (FRS): This requirement specifies the capabilities of the devices, its operations as well as its input and output characteristics.
  • Performance Requirement (PR): It covers the device behavior during use, and some of the behaviors can include; precision, ranges of quantitation accuracy, operational environmental ranges, and other performances.
  • Interface Requirement (IR): All interface requirements should be specified. Interface requirements can be either external or internal. However, all specifics relating to the interface should be listed.  External interfaces can be in the form of patient/product interface, external communication interface, and operation/product interface. Meanwhile, the internal interface can be software/hardware and communication interface. Each interface requires a review to ensure that the system works well together.

The documentation for each requirement often depends on the product and the organization. Although, almost all organization have functional requirement documentation or documentation that directly addresses design input requirements (DIR). Sometimes there are separate documents to capture specific requirements of the document such as a Mechanical Requirement Specification (MRS). Another example is the Electrical Requirement Specification (ERS) that are created within the sections or either the DIR or FRS documentation, Orcanos ALM system support over 58 different types of requirements and can be expended to more as needed.

Other requirements that deserve consideration are safety and regulatory requirement. We mustn’t forget the requirements for applicable risk management inputs.

Adequate Time

There should always be enough time to allow for the development of the Design Input Requirement (DIR). Each requirement should be ;

  •         Unambiguous
  •         Quantitative
  •         Contain expected tolerance.

The environmental conditions for optimal performance of the medical device and environmental specification for storage of the device should be stated. As much as is possible, organizations should try to capitalize on the standards set by the industry for each product. Nevertheless, the standards should be reviewed to ensure they cover and satisfy the design input requirements. A popular example is the referencing of ASTM D40169 for performance testing of shipping containers and systems as it relates to verifying the method of testing and packaging conditions. The standard sometimes might not cover the acceptance criteria like in this instance, and if such provision is left out of the DIR, the design input requirement will be incomplete.

It is expected that over the corse of product development, the design input requirement will change. For this reason, the change control will play a vital role in ensuring that the changes are reviewed based on their impact on other design input requirements, Orcanos traceability tools also includes integrated suspicious indication feature which proactively alerts on such possible impact. It is not unusual that a change in one requirement would affect another design input requirement. For more information see related links

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cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7

May 23rd, 2019 Posted by e-GMP, Requirements Management, Standards and Regulations 0 thoughts on “cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7”

Most device manufacturers find the concept of design control confusing. However, design control is better understood now as a result of better structure. The foundation for every product quality is the design process. Similar to a building, the better the foundation, the lesser the risk of collapse. In terms of design, the final product is dependent on the design process.

The design control process can be implemented for medical devices, manufacturing equipment, and operation, and software systems can make use of a similar process.

Below is a diagram of the waterfall system of design.

Waterfall Design System


The diagram depicts a simplistic version of an approved FDA control guidance. The design is typically more complicated due to several elements developing at the same rate. However, the waterfall diagram does serve the purpose of aiding understanding of the operations of the design process.

Common Mistakes in Design Development

One of the prominent mistakes to make is to assume that design control is the same thing as the development process. Although, the development process is a vital part of design control, a more accurate description for design control is to envision it as a lifecycle.

By picturing design control as a lifecycle doesn’t mean that design control will cover requirement for feasibility or marketing. While these processes are vital to the product development process, regulations are in place to monitor product design rather than concern itself with the success of the product in the market. Regulations are more about the safety of the design product instead of the general welfare of the business.

It is important to differentiate between the design input requirement and the marketing requirement and feasibility studies. The design input requirement is also known as the product concept document.

Document Approval

A common problem that most organization face is the approval of documents. There is always a reluctance to approve product design documents as they have to create a room for change and improvement on the document. However, by maintaining control over the document, the approval process tends to become tedious. The goal of control is not to restrict flexibility but to ensure that every phase of the design process is sync, especially when dealing with cross-functional teams.

Typically, approval can be given for revision 1 of a document with To-Be-Determined (TBD) values in certain sections. Meanwhile, teams can start preliminary drafts for the second revision of the document. Subsequent sections will address the core elements of the design control process. However, implementation of the process will depend on the following;

  • The maturity of the company.
  • Product complexity.

It is worth noting that most organizations prefer to breakdown these processes into individual (SOPs). But, it is possible to have a document that covers all the requirement of several elements of the design and development control process.

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cGMP (ISO13485:2016) – Validation Master Plan (VMP)

April 18th, 2019 Posted by e-GMP 0 thoughts on “cGMP (ISO13485:2016) – Validation Master Plan (VMP)”

Part of the GMP,  a Validation Master Plan (VMP) is a way to clearly define or layout the requirements for process validation and the justification for those validations to better help medical device manufacturers. Organizations seeking control or methodology to a specific process, often make use of a validation master plan.

An integral part of a company’s Quality Management System especially if the company specialized in biotechnology, pharmaceutical, and medical device manufacturing, is the validation of their process, product, and facility.

The VMP differs from the Standard Operational Procedure (SOP). VMP is used to prioritize objectives, makes plans on the steps to take for a particular procedure while getting the steps ready for approval. On the other hand, the (SOP) showcases the exact procedure to follow to complete approved tasks. Also, the VMP records the total work put into supporting a process, and it includes; apparatus, benefits, activity, prerequisite, and strategy.

Although, by FDA Quality System Regulation (21 CFR 820), Validation Master Plan (VMP) does not require a formal prerequisite. However, it is beneficial to have a top quality VMP to execute an efficient procedure validation program.

What is Validation Master Plan?

A Validation Master Plan is part of the Good Manufacturing Practices (GMP) requirement as it pertains to biotech, medical device companies, and pharmaceuticals. The VMP is a report that chronicles and stipulate methods and equipment that require approval, the reason they are needed and the plan to ensure that a particular process is completed. Also, the person responsible for the validation process is mentioned in the report.

Owning a VMP will go a long way in ensuring that you can overcome several difficult scenarios that are sure to come up in very regulated areas.  FDA auditors requesting for detailed documentation or procedures, equipment, and validation plan is not uncommon in the industry. While, it isn’t a formal request to have a validation plan, having one prepare will reduce the chances of attracting a warning letter from the FDA.

The Purpose of a Validation Master Plan

The life cycle of the manufacturing validation process is discussed in the VMP, and it best to integrate the legal paper with the VMP to better improve the overall outcome. Likewise, VMP can be regarded as a project planning tool.

The VMP proofs to be beneficial in prioritizing goals, predicting the necessary capital, provide insights and timeline for specific projects. In addition to that, the VMP helps to track effort and document approval status for products, various activities, equipment, benefits, activities, and prerequisite.

Finally, the VMP helps to keep an overall agreed upon record for instrument approval system and general procedures. The plan can be easily given to controllers to justify approval impacts. Also, medical device manufacturers can leverage on the VMP to show that they manufacture medical devices with the focus on quality while ensuring that the manufacturer bears the responsibility for the manufacturing system quality.

What Makes UP a Validation Master Plan?

Ideally, the VMP should consider risk and include the likely effects of the current manufacturing practice on product quality. In so doing, the VMP will be able to pinpoint the procedures that require approval and in what order the validation be executed.

Risk assessment does help identify which procedures that do not need approval, using Orcanos RISK management system. Therefore, it is important to survey and examine the effect of each manufacturing process has on the quality of the final product. If justification is needed for any additional prerequisite and extension that may have been added to the validation, then the VMP can be of help.

What should be in a Good Validation Master Plan?

The Code of Federal Regulations does not have any VMP facts. However, Guidance for Industry has suggested the following be incorporated into a standard VMP;

  • All likely review and simultaneous validation activity.
  • The request, time, area and need for validation activities
  • A report that helps communicate the validation approach to the organization.
  • A detailed account of the timeline, procedures, events, and facilities.
  • Details of departments that have consented to the project.
  • A reference that describes all designs for a validation training program
  • Details on people capable of providing SOPs approval, VMP, conventions, those surveying task, and monitoring tracking systems.
  • There should be details and copies of all approval plans, current SOPs, approval reports, and conventions, pressing strategy records and much more similar information.

Components of a Validation Master Plan (VMP)

  • Table of Contents: Table of contents offers a glimpse into what in the VMP, the critical areas as well as direction to the relevant data.

Sample TOC:


2   SCOPE.














  • Authorization and Title Page (dates with approval signatures): The title page will have document number, version, the title, clearly defined management agreement s and QA, these are provided automatically by Orcanos eDMS system for Document Control.
  • Validation Plan: The VMP will help identify why validation is required, what should be validated, where, when and how the validation should be done. The plan will also include a step of procedures broken into the section as well as which methods are vital to the project.
  • Abbreviations and Glossary: Technical terms and organization terminologies will be explained in this section.
  • Approach and Purpose of Validation: The purpose of the VMP clearly states with supporting logical statements the validation approach. The document must be detailed and concise to make for a comfortable and comprehensive read for the end users. The reason for the VMP’s showing of frameworks, procedures, equipment, and structured execution can be explained by the approval approach. However, the proposal does assure that validations will be executed by the approved protocol that is written. With the assurance of reliable method and arrangements of the framework, change of control and capability I bound to exist. Following this approach, all products are sure to follow a well-documented risk evaluation assessment when it comes to their manufacturing procedure and framework.
  • The Scope of Validation:  Scope covers utilities, systems, processes, procedures, equipment that might impact the final product during manufacturing as it pertains to VMP. Based on the documented risk evaluation, the scope must capture extensively the frameworks, procedures, utilities, and strategies that will be validated. Likewise, who and what should be stated clearly in the scope. It is vital that from start to finish of the VMP, readers can understand the scope.
  • Outsourced Services: In the VMP, services that relate to the management and selection of qualifications, calibrations, and activities performed by a third party.
  • Roles and Responsibilities:  this part of the plan will contain details of the role the VMP department concerning the preparing of validation protocols, change control documents, tasks reports, validation SOPs, maintenance and storage of validation-based documents. VPM will be kept by during manufacturing and designing through convention deviation, approval convention, tasks reports, and control records while the QA will be approving and reviewing protocol deviations, SOPs for consistency with cGMPs, task reports, validation protocols, approval to implement and consistency with procedures and policies.
  • Deviation management invalidation: Methodology for documenting deviations must be addressed in the VMP.  Also, when a deviation occurs during approval, it is to be noted and studied to examine methods or features of the approval convention to determine what corrective action to take and what endorsement for approval should be expected (CAPA), using Orcanos electronics CAPA Management system.
  • Risk management principles in validation: With relations to the validation process, risk management principles should be included in the VMP.  The assessment should cover design, deployment and the entire lifecycle of a planned project, using Orcanos RISK management system according to the ISO 14971:2012.
  • Change Control in Validation: A change management (ECO) system must be in place to cater to any changes that may impact the validated process and be documented in the Validation Master Plan, using Orcanos ECO management software.
  • Training: The VMP must define personnel that would be involved in a project, the qualifications they need and training they must undertake to ensure they perform excellently, using Orcanos Training management system.
  • All Validations: This is the totality of the VMP, and it includes an analytical method, cleaning, processes, equipment, premises, computer validation, qualification, utilities, and revalidation, using Orcanos Validation management system.

A general overview of the details contained in the VMP includes vital areas such as manufacturing areas, central plant, and material storage. Similarly, connections and illustration should be part of the VMP and differentiate between regions, for instances Non-GMP regions against GMP regions. Other things to be considered or incorporated include; general acknowledgment criteria, major advances in hardware, procedure, frameworks and any other changes that need to be part of the VMP.

  • Validation Matrix: The Validation Matrix is to list all the necessary validation throughout the facility. Using a matrix, timelines to execute crucial approvals will be a reality.
  • References: There must be rundown records of all activities, directions, execution, and capabilities in the VMP, using Orcanos traceability tools.

Quality Assurance is top-priority for everyone who is part of the medical industry, hence the need for the Validation Master Plan (VMP). As part of our Orcanos system and services, we handle OQ, IQ, and PQ protocol using the Orcanos testing system. Reports from our system can be generated in any format and data settings. Orcanos eGMP provides full-scale capabilities to allow any organization to conduct it VMP obligations using the Orcanos eFroms system along with its build in process automation infrastructure and increase organization efficiency by 10’s% and reduce risk during the production process.


Related Links

Audit Preparation and Participation as Part of the eGMP

March 30th, 2019 Posted by e-GMP, regulation compliance 0 thoughts on “Audit Preparation and Participation as Part of the eGMP”

In this post, we will discuss how to maintain a constant state of audit Readiness for unexpected audits, as well as what you can do to prepare before the audit commences.

Gathering commonly requested items ahead of time we will also take an in-depth look at the role of the audit coordinator and provided detailed recommendations for the audit Operation Center.

Next, we’ll talk about how to handle the audit itself including the opening meeting gathering documents for the auditor answering the auditor’s questions laboratory facility tour and the exit meeting.

Maintaining Audit Readiness

As some audits can be performed without notice or it’s very short notice the laboratory should operate under a state of audit readiness at all times if you do receive a notice of the audit there are a number of things that can be done before the audit commences.

  • Review your Laboratories SOPs on receiving inspectors and handling inspections.
  • Review past inspection reports, and attempt to identify items that may be a particular interest or concern to the inspectors.
  • Try to determine the identity of the auditors and their area of expertise.
  • Assign each inspector a host.
  • Determine, as far as possible, the scope and methods of the audit, this will often be discussed during the initial meeting.
  • Book rooms for the auditors and a room to act as the operation center.
  • Identify subject matter experts for each area together with substitutes.
  • It is not unknown for auditors to request to observe a demonstration of a particular method. This may, in particular, happen during a client audit when the client wishes to assess the competency of the laboratory to perform a particular test.  It would be good practice to identify someone with significant experience to perform any demonstrations before the audit commences.
  • Establish as much as possible a tour route.
  • Walk through the tour route and check all of the following:
    • Instrument log books instrument status and calibration status.
    • The expiry date of chemicals, reagent, mobile phases and solvents – remove or revise all out-of-date reagents.
    • For laboratory glassware, in particular, confirm the calibration markings on volumetric glassware are clearly visible.  Also, confirm that the correct grade of glassware is being used and be able to confirm this with the documentary evidence.

Review testing schedules, it is best to concentrate on routine work during an audit, especially a regulatory audit, and avoid working on more challenging activities such as investigations.

Using Orcanos eQMS system allows you to control electronically the audit readiness and allow you to stay focus on the daily tasks. Orcanos provides a set of reports you can have free access to such as:

  1. Audit Readiness – SOP Annual Review (Effective Date > 300 days)
  2. Audit Readiness – Previous Process Checks with Low Grade (1 – 3)
  3. Audit Readiness – Deviation Summary Reports
  4. Audit Readiness – Complaint Investigation Report
  5. Audit Templates
  6. Many more…

It is a good practice to have such documentation readily available on site. If necessary Orcanos eQMS system will allow recalling all such documentation electronically with no need to go onto the remote site. Orcanos system will preserve your data for at least 15 years and more so no need to archiving.



NOTE: These recommendations are also applicable for Good Laboratory Practice (GLP) required by the ISO 13485:2016 and now by the new MDR and MDSAP.


March 14th, 2019 Posted by ASPICE, Automotive 0 thoughts on “OPORTUNIDADES EN LA NUBE PARA EL SECTOR AUTOMOTRIZ”

Los servicios en la nube implican la traslación de datos o información al Internet utilizando servidores remotos. Esta práctica se trata del almacenamiento y la administración de datos utilizando Internet en lugar de las computadoras locales. La industria automotriz es un sector importante que puede beneficiarse de la migración a la nube. Esta industria es conocida por su enfoque en la tecnología y la innovación, lo que hace que el servicio en la nube sea una solución perfecta. El servicio en la nube puede ser utilizado para lograr lo siguiente en la industria automotriz:



La mayoría de las empresas automotrices gastan mucho dinero adquiriendo infraestructuras internas y hardware de TI para el almacenamiento de datos. Asimismo, gastan dinero en tener estas infraestructuras actualizadas y en mantenerlas. El servicio en la nube ha proporcionado una forma de erradicar esto.  Ahora, los datos se pueden cargar en un servidor remoto, y el proveedor de servicios será responsable de la gestión y reparación de los servidores, lo que ayuda a las empresas a reducir el costo inicial de la creación del departamento de TI con recursos humanos y equipos, así como el costo de mantenimiento de la gestión y reparación de los equipos.


El servicio en la nube ha permitido que los vehículos inteligentes adviertan a los conductores de una inminente fatalidad o tomen las medidas necesarias para evitar tales situaciones. Por ejemplo, actualmente muchos autos alertan a los conductores de condiciones peligrosas en la carretera, algunos incluso van un paso más allá tomando medidas en favor del conductor, por ejemplo, un freno de auto se activa justo antes de que se produzca una colisión. Estas mejoras han ayudado a reducir el índice de accidentes en la carretera, ya que el conductor no es la única mente “inteligente” en el automóvil.


El acceso a la nube ha hecho que conducir un auto sea una actividad divertida. La mayoría cuenta con sistemas de GPS y también se conectan a Internet a través del teléfono del conductor. Ahora se pueden obtener actualizaciones de tráfico en lugar de tener que revisar los teléfonos continuamente mientras se conduce. Además, esto alivia los sistemas de “información y entretenimiento” de los fabricantes de automóviles al utilizar la nube para obtener información sobre el conductor y, por lo tanto, las actualizaciones se adaptan a las necesidades del mismo.


Las instalaciones automotrices pueden aumentar su seguridad y minimizar sus riesgos de fallas haciendo algo tan simple como trasladarse a la nube. Los proveedores de servicios en la nube cuentan con personal experto dedicado que trabaja todas las horas del día gestionando y garantizando la seguridad en todo momento; estos expertos también llevan a cabo comprobaciones rutinarias para evitar tiempos de inactividad.  Además de esta protección las 24 horas del día, los entornos de la nube también crean copias de seguridad de datos e información, y la empresa automotriz no estará expuesta después de una pérdida accidental de datos. La tarea más importante que realizan los proveedores de servicios es proporcionar un control de seguridad potente (cifrado).


Cuando se trata de la industria automotriz, hay muchas piezas móviles, así como datos relacionados con la producción de un vehículo. La industria es compleja y maneja información relacionada con actividades tales como simulacros de ingeniería, procesos empresariales, demanda, análisis de clientes, logística y mucho más. La administración de dicha información puede ser muy tediosa y difícil de comprender. Sin embargo, con la introducción de los servicios en la nube en el sector, los fabricantes pueden aprovechar fácilmente la facilidad que ofrece el entorno de la nube para clasificar los datos de forma rápida y eficiente.


Sobre el autor, Rami Azulay

Rami tiene más de 24 años de experiencia en varios puestos de desarrollo de software y control de calidad. Utilizando su amplio conocimiento de las operaciones y la calidad, Rami fue uno de los principales arquitectos del software Orcanos en 2005 y más tarde se convirtió en el vicepresidente de ventas y marketing de Orcanos. Rami tiene una maestría en Ciencias de la Computación.


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