CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I

July 7th, 2019 Posted by Requirements Management Tool 0 thoughts on “CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I”

Corrective and Preventive Action (CAPA) is a way to improve the company’s processes. They are a series of actions that eliminate unforeseen events and causes of non-conformities. Likewise, CAPA, as a concept falls under several ISO business standards and Good Manufacturing Practice (cGMP).  The primary focus of CAPA is focusing on the root causes of specified problems and risks. In so doing, it can help ensure that they won’t be a need for either corrective action or preventive action in the future. This article aims to help you understand the CAPA process within a regulated environment.


The outline on the subject of CAPA is as follows;

  •         Background
  •         The current State of CAPA
  •         Process Requirement
  •         Process Analysis
  •         The CAPA status review
  •         Conclusion


Two major forces drive the CAPA system. In the US, there is the Food and Drug Administration, the federal regulations, Title 21 Part 820 Subpart J, and CAPA Section 820.100. Meanwhile, companies in the EU that accept the ISO 13485 standard for the quality system there is the Section 8.5.2 corrective action and Section 8.5.3 preventive action. It is worth mentioning that 820 will be known as 21 CFR 820, and 13485 will be EN ISO 13285:2016. Also, there is not of a difference between the old 13485 standards of 2003 and the updated version of 2013 but there are some changes on the 2016 edition when it comes to CAPA requirement.

It is a requirement for both the US FDA and ISO 13485 that CAPA procedures be documented. In the descriptions for CAPA in both organizations, they both address non-conformities.

Regulatory Confirmation

The eligibility criteria for a CAPA system mandate that a situation of non-conformance or a risk of having it. The common suspects for non-conformance issues are either components, products or something physical. However, processes are also suspect despite being less obvious. Regulations often demand that organizations follow specific processes when collecting or analyzing artifacts. Non-conformities are bound to happen when processes are ignored, and there is no collection of artifacts.

CAPA has two distinct components, namely, corrective action and preventive action. Corrective action is used to address systemic non-conformities when they occur. Meanwhile, preventive actions help to address the risk of non-conformities that are likely to happen. In that sense, an electronic system such as Orcanos must let you conduct traceability to CA/PA activities as well to RISK and its mitigation.  

Image1: Orcanos Traceability from/to CAPA

Only About Compliance?

There are pivotal debates regarding the CAPA system. There is an argument that if there is a systemic non-conformity, then action should be taken to identify why and take action to fix and prevent the occurrence in the future. On the other hand, companies find preventive actions problematic. It is not unusual that companies take precautionary steps frequently in the form of reviews, prototypes and much more. However, rarely do they run the steps through the preventive action process.

Despite CAPA and DR (Design Review) and report topping the list, it is difficult to ascertain the safety and effectiveness of products considering the high rates of recalls. A non-scientific approach to the various findings reveals that there is a lack of understanding when it comes to the CAPA approach. The result leads to a lack of implementation. For example, stating that all CAPA will be closed in 60 days in the CAPA Standard  Operating Procedure (SOP) is wrong. The action further demonstrates a lack of understanding of the CAPA process. Inspectors are left with no choice other than issuing findings to processes that they can’t implement or follow.

Therefore, this article will be highlighting realistic ways to approach the CAPA process. The hope is that it will reduce any form of self-damage when it comes to findings and equip you with tools that will guide the regulatory compliance of your business. Eventually helping you making a choice to move onto some electronic form of system to manage the CAPA complete process.

The Basics of Corrective Action

Corrective Action is the first section of the CAPA. Identification of non-conformities tends to trigger corrective action. Although, the language in 820 when addressing CA is cause for confusion as it stipulates action to eliminate reoccurrence. There will be clarity on the subject further down the line.

The Basics of Preventive Action

Preventive Action (PA) represents the other half of CAPA. It becomes actionable in situations where there is a risk for non-conformities, and no steps are in place to mitigate such risks. IT worth mentioning that while in the 13485 standards, there is a distinction between CA and PA. While in 820, there is no such distinction when it comes to CAPA. 

We stated that PA is a frequent feature as part of a company’s project risk activity. The activities often include design and review for manufacturing, preventive maintenance and much more. However, the challenge is identifying when to apply preventive action.

Key Concept

The inconsistent use of terminologies is to blame for the problems in the findings of the CAPA system. To correct this notion, we will be using some easy to grasp terminologies in the absence of standard definitions.

  • Corrections: They are actions taken to resolve problems like replacing a faulty capacitor in a circuit board. Another example is fixing a software bug that alters the user’s input.
  • Corrective Actions: Actions that helps ensure that a problem will no longer occur. For example, changing your capacitor supplier cause they supply faulty resistors to a more reliable supplier. Alternative, training a programmer on a concept that they made an error while working.
  • Preventive Actions: Actions that will stop a problem from happening. An example is reviewing a capacitor’s rating before use to estimate the likelihood of fault. Alternatively, set up a coding standard that programmers can use to review their code to prevent problems.

Systemic Issues

It would not be efficient to flood the CAPA system with every issue. As an alternative, only system issues should be in the CAPA system. Now, the question becomes, what is a systemic issue? In simple terms, it refers to problems that will keep happening without any intervention. System issues can manifest in the following ways;

  • Quality: Missing procedures in the quality process.
  • Product: Failure that keeps rerepeating.
  • Manufacturing: Out tolerance results that don’t stop.
  • Process: Missing steps or lack of actionable steps.

Non-Systemic Issues

By describing non-systemic issues, we better understand the difference between it and systemic issues. Non-systemic issues are problems that are likely to happen once or possess low reoccurrence probability. When dealing with processes, fallouts are not unusual. Therefore, having fallout that is within the limits of the process makes the problem non-systemic. Checking trends and frequency of a problem occurring is the best way of determining if it is non-systemic. However, if you have a non-systemic and non-conformity problem, the action is required.

Some of the best practices will involve checking the trend of all non-conformities, and assessing non-conformities to determine the disposition. Orcanos eQMS system includes a Non-Conformities eForm that will allow you to report and measure your NCR. 

Systemic Issues Product Examples

Below are a few examples that showcase system issues in products.

  1. Should the door be open, an infusion pump will not prevent free flow. The free flow is a systemic issue as the door opening with a set installation will not stop people from seeing the patient.
  2. Cross-contamination of duodenal scopes is responsible for a spate of infections. The reason is that the scopes were not cleaned properly to prevent infection. The problem might have fallen under non-systemic issues if it happened just once. However, the frequent rate at which the infection keeps occurring makes it a systemic issue.
  3. After several testing, making parts that do not match their corresponding mating part as per specification. The rate at which this error occurs and the fact that it surpasses the process limit makes the error systemic.

Systemic Issues Process Example

Problems can come from other factors like processes rather than the product.

  1. When an audit reveals that the quality system failed to incorporate a CAPA requirement. For example, a means of assessing the effectiveness of corrective action. The problem becomes systemic if the process is already reviewed, approved and documented.
  2. An FDA inspection revealing that a company does not keep a record of customer complaints and then issues them a 483. The problem is systemic if the people responsible for taking the call do not realize that all customer related calls should be recorded.

On our upcoming post about CAPA, we will give more tools and tips about how to improve the handling of the CAPA process and be more effective.

cGMP – Design & Development Review Principles (9)

July 1st, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Design & Development Review Principles (9)”

It is quite essential to have a formal design review process. When designs are made or put in place, it is of utmost importance that they are reviewed. A formal review process will help you critically analyze a design in its entirety.

Design Review

This consists of a documented evaluation of the design. It is a comprehensive and also a very systematic process. A design review possesses the data gotten after the proper examination of a design. In a nutshell, it seeks to also carefully evaluate the adequacy and/or capabilities of the design requirements.

One of the most important reasons why a design review is a must is because it will help to identify the problems in the design. While that is really a plus, it is not its only function as it can also help to implement corrective actions to said problems. Design reviews are usually enforced at a more specific/critical stage of the design. However, there are a few other instances that may warrant a design review.

Uses of a Design Review.

The necessity of a design review cannot be overemphasized and this is because it can be used to achieve the following;

  1. Project Progress – In order to formally determine the progress level of a design project, you will need to conduct a design review.
  2. Provide Feedback – A design review helps to provide a comprehensive analysis of the design. This feedback can be used to generate useful data during the design process.
  3. Notification of Emerging Problems – A design review is still your best bet in discovering problems that may arise in a design project. It serves as a check and balance system during the design process.

Orcanos Design Review System

Factors that Influence the Phases of a Design Review.

There are two major things that directly influence the number of phases in a design review. They include;

  1. The Organization – The organization responsible for the design would usually have their own unique parameters or systems in place when making a design. Depending on the bottlenecks in the design process as per the organization’s procedures, a design may have a single or multiple phases in its design review.
  2. The Complexity of the Product – For a simple product with minimal interfaces, it is possible to have a design review with only a single phase. However, if the product is a complex one, it follows that it would generate more than one phase due to its numerous interfaces and sub-systems.

Design Freeze.

This simply refers to a stage in the design review process where design cannot accommodate any more changes. However, this stage will only allow changes if a formal change is made to the design.

Orcanos Freezing Mechisim

Collection of Reviews.

A diverse number of reviewers are typically required when conducting a design review. When orchestrating a review, it should be a collective one where the reviewers are both in-house and external. This would allow for an unbiased examination and final judgment on the design. These reviewers should be in fields such as;

  1. Electrical engineers; a reviewer with a good understanding of electrical appliances and how they work will be essential to a team of reviewers.
  2. Software engineering; one with expertise in this field would be a viable option for a review team.
  3. Manufacturing; this goes without saying as whatever is being designed will eventually need to be manufactured. 
  4. Quality assurance; someone needs to be able to check the quality status of the design.
  5. Regulatory affairs; guidelines must be followed and the necessary rules adhered to and this is where someone with such skill comes in.
  6. Mechanical engineering; this reviewer will be capable of understanding the mechanics of the product.

Others include reviewers in marketing and clinical and also customers (either through direct or indirect participation). Lastly, an important member of the team is the independent reviewer who bears no direct responsibility but has a technical understanding of the device and brings a fresh perspective to the table. 

Systematic Process.

We have said that the design review follows a systematic process that allows for the documentation of the progress of the design. Should there be any need to update the design, the new changes would have to be effected in the design input document. Depending on the level of changes made, there may also be a need to redesign the product or simply change the labeling.


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OrcaMotive ASPICE Event Madrid Spain 2019

June 18th, 2019 Posted by Requirements Management Tool 0 thoughts on “OrcaMotive ASPICE Event Madrid Spain 2019”



Tel: +972-3-537-2561

OrcaMotive Event – Madrid Spain 2019

¡Usted está invitado a nuestro evento OrcaMotive! Orcanos es un proveedor líder en el ciclo completo de gestión de cumplimiento para la industria automotriz.

Este evento presenta consejos y tecnología para cumplir con los requisitos de cumplimiento y regulaciones de la industria automotriz. El mismo discutirá cómo actualizar su organización respecto a los requisitos de ASPICE e ISO 26262 utilizando tecnología y herramientas avanzadas.

You are invited to our OrcaMotive FREE event! Orcanos is a leading vendor in the compliance lifecycle management for the Automotive industry.

This event showcases tips and technology to meet the compliance and regulation requirements for the automotive industry. The event will discuss how to bring your organization up to speed with ASPICE and ISO 26262 requirements using advanced technology and tools.


 Wednesday, 17th July 2019 at 13:00 PM

 Paseo de la Castellana 43, 28046, Madrid Spain
Mr. Benny Prujan | Director, Program & Functional Safety Manager |  Valens Semiconductor, Israel

Functional Safety Introduction

Mr. Rami Azulay | Head of Sales and Marketing | Orcanos, Israel

Quality system requirement and implementation for ASPICE compliance requirements

Copyright © 2019, @ All Rights Reserved. |

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 – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7

May 11th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Design & Development Plan (DDP) – ISO 13485:2016(6) Clause 7”

Defining the stages of design and reviewing every stage of the design process is one of the requirements of ISO 13485 Section 7.3.5 for design and development. The task of identifying and reviewing designs at every stage is accomplished using the design control SOP. Once the User Requirement and Specification (URS) for a medical device is established, the next step in the planning stage is the Design and Development Plan (DDP).

Every product has its unique design and development plan, and they appear in the products documentation as either DDP or D&DP.  There are two main things to consider when creating a Design and Development Plan for a medical device.

  1.      Draft the plan and approve it using the design control system.
  2.      At crucial moments in the design stages, update and review the plan.


What is in the DDP

The Design and Development plan will differ with the complexity of each product as well as with the organization that produces them. For a simple product, the DDP can be in the form of a basic flow chart. However, with a more complex product, the design and Development plan will be in the form of a well-detailed Gantt chart.


The first thing that the DDP should cover is the objectives and goals for the product. This will help clarify the purpose of designing the product and its functions. Next, the DDP should note the various departments involved in the designing of the product and their roles. In addition to that, information on contractors or sub-contractors that will be contributing to the project. The assignment of responsibility as well as documenting them is vital to the success of the product design. Likewise, collaborations and shared responsibility should be elaborately defined to eliminate ambiguity or confusion. This is vital if the project involves multiple teams or departs.

The design and development plan should also have a breakdown of tasks alongside the people/team responsible for them. The task breakdown should include the following;

  • The time duration for the product design.
  • The resources that would make the project a success.
  • Individual responsibility for set tasks.
  • Allocation of resources.
  • Criteria for fulfilling each task
  • Collaboration points and the teams are collaborating on a specific task.

The task breakdown will help optimize the time it takes to complete the product and get it ready for the market. There should be a report documenting the target for each task, and it should have tests and studies that prove that the product is safe for use. Some of the tests and studies to consider are as follows;

  • Shipping studies
  • Biocompatibility testing
  • Validation of sterilization processes
  • Non-Clinical animal studies
  • Electromagnetic Field (EMF) Interference studies
  • Mean-time-to-failure-studies
  • Clinical evaluations


The tests and studies to be conducted will depend on the type of product design and the function of that product.

Another set of criteria that should be present in the design and development plan is what to expect from the activities of design transfer, and how to monitor what is being transferred. The expected result from the design process should also be weighed against the process input.

Problem with Design and Development plan

The biggest problem that comes with a DDP is the way the project manager tends to overestimate the product design timeline. Usually, such a problem arises with a lack of experience, lack of optimization and flexibility to the plan, and trying to work backward. It is important that tasks are completed on time, but there should be room for updates to account for unforeseen circumstances in the design process.

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cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7

May 4th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – Customer Related Processes and Requirements – ISO 13485:2016(4) Clauses 7”


The purpose of Customer Related processes as stipulated in the ISO 13485:2016, is to make sure that companies keep to a high standard when it comes to the products and services they offer to customers. In other words, it is a way of ensuring that the customer is the focus of the company and its product.

What the ISO 13485:2016 is hoping to achieve is a document that outlines an established User Requirement. The practice which started with the software industry helped to ensure that products meet the desired outcome of the end-users. Companies in today’s world, are concerned with how the user interacts and experiences the product, rather than what they need in their design process. Hence, abandoning the need for User Requirement for User Experience.

Apple products are an example of how design focuses on user experience instead of user requirement. Henry Ford, the famous founder of Ford Motors, made a quote that reveals a unique flaw with user requirement. He said that if he had been opportune to ask people what they required, they would have responded that they needed faster horses rather than cars.

While the software industry is embracing the concept of user experience, the medical device industry is still relying on user requirement. Although there is hope that the medical device sector will get there, we will be addressing User Requirement Specification (URS) as a part of the ISO 13485 clauses for customer-related processes and requirements.

Considerations Demands by ISO 13485 for Product Requirement

One of the most vital requirements for the product, as stipulated in the ISO 13485 clause, is the requirement for both delivery and post-delivery of products. There have been cases where companies failed to supply requirement for products as they relate to the installation, maintenance, training, packaging, calibration, and servicing. The ISO 13485 does mandate that these requirements be available and if they aren’t, they should be a justified reason for their absence.

Typically, not all products require all parts of the requirements. For example, the User Requirement Specification (URS) for a disposable device might only contain a section that justifies why there is no product requirement for calibration, servicing, maintenance and training. Additionally, another critical information stated in ISO 13485 is the fact that requirements not mentioned but needed for the product use will be identified. The stipulation helps to address the intent for consideration for product requirement during usage.

A disposable contact lens is an ideal example in clarifying implied consideration for the product requirement. Let’s say that the average shelf life for the contacts is 2 years as stipulated in the product requirement. However, the contact usage life cycle after the customer opens the seal is not accounted for in the requirement. Hence, should a customer use the lens for a week consistently before discarding it, while testing under such conditions has no to be done, implied product requirements means that the company has violated a requirement under the ISO 13485. Likewise, companies have to fulfill all applicable requirement such as the region and market for the product to best determine which product requirement to follow and note them in the product requirement document. In totality, even though the requirements may be specified or implied, they have to be met.

Product Requirement Review before commitment

This section of the ISO 13845 mandates the review of the product requirement long before the product gets to the customer. The review should cover the following;

  • The documentation and definition of product requirements.
  • The fulfillment of all applicable regulatory requirement.
  • Updates on contract requirements that exist in previous product requirements.
  • The capability of companies to satisfy the requirement.
  • Planning and execution of required training.

All the review requires are pretty standard and can be met easily. The design and development team is responsible for the generation, design, and review of a URS document. Similar to every other report, the User Require Specification document will be revised for the entire length of a product. It is crucial that recisions be tracked and noted and more critical, changing numbering each revision or updates should be avoided as references to previous updates is a possibility. Similarly, with each new update and stage in the development of a product, the URS should be revised and updated. The same principle applies to contract updates for customer-based products as changes that exist with previous requirements need to be addressed.


Communication is the last major part of customer related process under ISO13485 and must be appropriately managed. All forms of communications with customers to be the individual or commercial customer requires careful consideration. A requirement that covers all forms and ways in which communications with customers are performed must be made available. The requirement covers; inquiries about orders, contracts and their amendments, product information, advisory notes, and feedback processes including complaints.

Also, there needs to be a way to categories which customer related communication that should be submitted to regulatory organizations alongside a scheduled time and system for the process. The communication that organization submits will vary with where they market their product and the industry category of their product.


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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.


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