Integrate Market Into Development

May 10th, 2012 Posted by Requirements Management Tool 0 thoughts on “Integrate Market Into Development”

Trends in ALM domain

Key trends in the development lifecycle include Product Data Management (PDM), and more and more ALM (Application Lifecycle Management) solutions find their way to organizations dealing with software development. The most important challenge is to efficiently integrate product development with product management, by creating a communication channel between the development team with the product management.

Challenge of product management

Successful product management includes the combination of marketing, R&D, high quality assurance and deployment in one integrative process. Turning market information into products is the key to successful business. However, inputs from markets are often misunderstood, or lost along the way. Moreover, inputs can be extremely complex and demanding. These inputs need to be assessed from various points of view, such as complexity, market valufe and costs.

Benefits of integrating product management to development team

Product Management delivers benefits to both the provider and the consumer, by integrating the customer needs into the development. The provider is benefited because he is producing better products that find consumer needs, thus becoming competitive. On the other hand, the consumer benefits because he gets better quality product that finds his needs.

How QPack integrates market to development

Gather: QPack provides a professional tool for the product manger, allows him to gather and trace market requirements derived from customers and end users.

Define: These requirements are managed as first phase of the development process, and the development team defines the product features, based on these requirements. This gives strong traceability between market requirements and product requirements (features).

Trace: The product manager can easily trace each market requirement and review the product features designed to solve it. He can also see for which version each market requirement is planned for.

Drill: The product manager can also trace deeper if necessary, and review each requirement activities, in terms of coverage and quality.

qpack medical 21 cfr part 11

May 1st, 2012 Posted by Requirements Management Tool 0 thoughts on “qpack medical 21 cfr part 11”

Using software system  in the medical device development process requires compliance of software systems with the  IEC 62304.

QPack support for IEC 62304:


– Assure software system electronic records integrity control

– Manage your software system requirements specifications

– Manage and control the validation and verification process (V&V)

– Dynamic testing

– White Box and black box testing

– Test results summary

– Generate validation reports  with a click of a button

– Risk and hazard management

Assure software system electronic records integrity control


In fact, you can use QPack integrated ALM modules to assure your software system electronic records integrity. The following chapters discuss this capability in details

Manage software system requirements specifications in QPack


The company required to make SRS for every software system used by the company, Regardless of whether the computer system is developed in-house, developed by a contractor, or urchased off-the-shelf, establishing documented end user (i.e., a person regulated by FDA) requirements is extremely important for computer systems validation.

QPack ALM provides a complete Requirements management tool, including the ability to generate the required documents with a click of a button, embedding the traceability matrix table automatically. QPack provides software requirements’ traceability at all times to risk and hazard assessment process, and validation plan according to part 11 key principle, to optimize the application Lifecycle Management process.

The following image shows the establishment of end user’s needs and intended use using QPack hierarchical product requirements tree

Later on you are able to obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications using QPack  CFR part 11 document generation module and its dynamic filter capabilities.

The image above demonstrate the generation of the SRS to MS-Word document using QPack CFR part 11 document generation module

 

 

 

QPack provides the ability to embed query results inside documents, such as traceability matrix (shown in the image above), unresolved anomalies (defects and bugs), verification results (actual testing results), etc.

Manage and control the validation and verification process with full traceability

The FDA considers thorough documentation to be extremely important to the success of your validation efforts. Validation documentation should include a validation plan, validation procedures, and a validation report, and should identify who in management is responsible for approval of the plan, the procedures and the report.

QPack allows you to manage all required validation process.

Validation Plan


The validation plan is a strategic document that should state what is to be done, the scope of approach, the schedule of validation activities, and tasks to be performed. The plan should also state who is responsible for performing each validation activity. The plan should be reviewed and approved by designated management.

– QPack test management tool allows you to plan your testing procedures in order to validate the defined requirements, with full traceability between the tests and the requirements.

– Each validation task is assign to the relevant stakeholder using the workflow mechanism.

– QPack CFR part 11 document generation module allows you to generate the evidence document for your test plan and its traceability matrix, including tests results.

 

The above image demonstrate a relation between 2 requirements in QPack

Validation Procedures

The validation procedures should include detailed steps for how to conduct the validation. It should describe the computer system configuration, as well as test methods and objective acceptance criteria, including expected outcomes. The procedures should be reviewed and approved by designated management.

QPack test management tool allows you to design each validation procedure as step by step with full description editor.

The use of validation parameters increases the coverage of complex testing environments and provides data reuse of testing procedures.
Validation Report
The validation report should document detailed results of the validation effort, including test results. Whenever possible, test results should be expressed in quantified terms rather than stated as “pass/fail.” The report should be reviewed and approved by designated management. QPack reporting tools allow collecting all test results and summaries them in any evidence document format or structure. QPack is capable to quantify all measurements both into your final report and also during different project stages where KPI’s are required.

Dynamic Testing – test conditions

Test conditions should include not only “normal” or “expected” values, but also stress conditions. Test conditions should extend to boundary values, unexpected data entries, error conditions, reasonableness challenges

QPack includes test parameters in test procedures to manage values with ranges and conditions.

White box and black box testing

Structural testing – Unit test

Structural testing procedure  takes into account the internal mechanism (structure) of a system or component. It is sometimes referred to as “white box” testing. Structural testing should show that the software creator followed contemporary quality standards.

QPack allows you to plan and execute your “White Box” (Unit Tests) and reports results in evidence documents as required by the FDA.

Functional testing – black box testing

Functional testing involves running the program under known conditions with defined inputs, and document test results to pre-defined expectations. Functional testing is sometimes called “black box” testing.

QPack allows you to plan, design and execute your “Black Box” tests and generate your evidence reports which includes both your test step procedures (Expected Results) and your Actual results.

Test results summary

Quantifiable test results should be recorded in both quantified and qualified (e.g. pass/fail) terms. Quantified results allow for subsequent review and independent evaluation of the test results. QPack provides you to produce both Quantified results and with quick access the ability to drill down into deeper understanding of those results. All results can be embedded into evidence documents according to standard.

Extent of Validation – Risk & Hazard


When you determine the appropriate extent of system validation, the factors you should consider includes (but are not limited to) the following

The risk that the system poses to product safety, efficacy, and quality; note that product means the FDA regulated article (food, human or veterinary drug, biological product, medical device, or radiological product);

The risk that the system poses to data integrity, authenticity, and confidentiality; and,

The system’s complexity; a more complex system might warrant a more comprehensive validation effort.

QPack Risk and Hazard embedded capabilities in the system allows you to consider all the above factors and point on the mitigation entities located at any on the above evidence documents. QPack performs all tractability matrix needed to be printed out and also format the information for you according to the FMEA standard.

Medical device validation

May 1st, 2012 Posted by Requirements Management Tool 0 thoughts on “Medical device validation”

Medical device software validation

Medical device validation is a complex process that must be submitted to the strict regulations of the FDA. As a result, routine end-product software validation alone is often not sufficient to assure the medical device software validation. Some end-product testing have limited sensitivity, sometimes destructive testing is required to show that the process is adequate and in certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness.

The FDA believes through careful design and software validation of both the process and process controls, a medical device manufacturer can establish a higher degree of confidence. Successfully validating a process will reduce the dependence upon intensive in-process and finished product testing. To learn more about the FDA medical device software validation, you can review General Principles of Software Validation; Final Guidance for Industry and FDA Staff:

Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers. Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software.”

QPack software validation module for medical device validation is designed to meet FDA’s Quality System validation requirements such as those in regulatory affairs, quality assurance, process development or manufacturing.

QPack software validation module provides tools for medical device software validation that comply with FDA regulations.

As described in the General Principles of Software Validation; Final Guidance for Industry and FDA Staff, QPack supply the tools to comply with the guideline, described in the following section (chapter 4):

4.1. REQUIREMENTS

A documented software requirements specification provides a baseline for both validation and verification. The software validation process cannot be completed without an established software requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)).

4.2. DEFECT PREVENTION

Software quality assurance needs to focus on preventing the introduction of defects into the software development process and not on trying to “test quality into” the software code after it is written. Software testing is very limited in its ability to surface all latent defects in software code. For example, the complexity of most software prevents it from being exhaustively tested. Software testing is a necessary activity. However, in most cases software testing by itself is not sufficient to establish confidence that the software is fit for its intended use. In order to establish that confidence, software developers should use a mixture of methods and techniques to prevent software errors and to detect software errors that do occur. The “best mix” of methods depends on many factors including the development environment, application, size of project, language, and risk.

4.3. TIME AND EFFORT

To build a case that the software is validated requires time and effort. Preparation for software validation should begin early, i.e., during design and development planning and design input. The final conclusion that the software is validated should be based on evidence collected from planned efforts conducted throughout the software lifecycle.

4.4. SOFTWARE LIFE CYCLE

Software validation takes place within the environment of an established software life cycle. The software life cycle contains software engineering tasks and documentation necessary to support the software validation effort. In addition, the software life cycle contains specific verification and validation tasks that are appropriate for the intended use of the software. This guidance does not recommend any particular life cycle models – only that they should be selected and used for a software development project.

4.5. PLANS

The software validation process is defined and controlled through the use of a plan. The software validation plan defines “what” is to be accomplished through the software validation effort. Software validation plans are a significant quality system tool. Software validation plans specify areas such as scope, approach, resources, schedules and the types and extent of activities, tasks, and work items.

4.6. PROCEDURES

The software validation process is executed through the use of procedures. These procedures establish “how” to conduct the software validation effort. The procedures should identify the specific actions or sequence of actions that must be taken to complete individual validation activities, tasks, and work items.

4.7. SOFTWARE VALIDATION AFTER A CHANGE

Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the software needs to be re-established. Whenever software is changed, a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire software system. Based on this analysis, the software developer should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software change.

4.8. VALIDATION COVERAGE

Validation coverage should be based on the software’s complexity and safety risk – not on firm size or resource constraints. The selection of validation activities, tasks, and work items should be commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use. For lower risk devices, only baseline validation activities may be conducted. As the risk increases additional validation activities should be added to cover the additional risk. Validation documentation should be sufficient to demonstrate that all software validation plans and procedures have been completed successfully.

4.9. INDEPENDENCE OF REVIEW

Validation activities should be conducted using the basic quality assurance precept of “independence of review.” Self-validation is extremely difficult. When possible, an independent evaluation is always better, especially for higher risk applications. Some firms contract out for a third-party independent verification and validation, but this solution may not always be feasible. Another approach is to assign internal staff members that are not involved in a particular design or its implementation, but who have sufficient knowledge to evaluate the project and conduct the verification and validation activities. Smaller firms may need to be creative in how tasks are organized and assigned in order to maintain internal independence of review.

4.10. FLEXIBILITY AND RESPONSIBILITY

Specific implementation of these software validation principles may be quite different from one application to another. The device manufacturer has flexibility in choosing how to apply these validation principles, but retains ultimate responsibility for demonstrating that the software has been validated.

Software is designed, developed, validated, and regulated in a wide spectrum of environments, and for a wide variety of devices with varying levels of risk. FDA regulated medical device applications include software that:

  • Is a component, part, or accessory of a medical device;
  • Is itself a medical device; or
  • Is used in manufacturing, design and development, or other parts of the quality system.

In each environment, software components from many sources may be used to create the application (e.g., in-house developed software, off-the-shelf software, contract software, shareware). In addition, software components come in many different forms (e.g., application software, operating systems, compilers, debuggers, configuration management tools, and many more). The validation of software in these environments can be a complex undertaking; therefore, it is appropriate that all of these software validation principles be considered when designing the software validation process. The resultant software validation process should be commensurate with the safety risk associated with the system, device, or process.

Software validation activities and tasks may be dispersed, occurring at different locations and being conducted by different organizations. However, regardless of the distribution of tasks, contractual relations, source of components, or the development environment, the device manufacturer or specification developer retains ultimate responsibility for ensuring that the software is validated.

So, how does QPack supports these guidelines?

QPack supports any development lifecycle method, and supports all kinds of ALM activities such as requirements, development tasks, unit tests, QA activities and tasks, such as test cases, test scripts, defects and test execution sets. The system admin can define the relevant process and work procedure in the system to comply with organization working methodologies.

QPack manages the full application lifecycle process (ALM), thus allows QA team to start activities early in the process, right when requirements are defined. The work procedures are also defined early in the development phase, and control all development phases.

QPack requirements definition module provides a professional tool designed to gather requirements and trace them later on.

QPack provides a testing module that allows the QA team to implement testing methods and procedures in a controlled and structured way. The use of testing tool, that relates every test with the relevant requirement, assures product quality.

The reporting and analytic tools allow users to trace coverage of requirements by tests, thus assure the medical device validation process, and measure product quality.

qpack alm for software overview

May 1st, 2012 Posted by Requirements Management Tool 0 thoughts on “qpack alm for software overview”

QPack package for software is an end-to-end solution for Application Lifecycle Management, containing all development lifecycle modules, such as market requirements, system specs, development, testing, and delivery.

QPack ALM package for software supports the marketing team, system architects, developers and testers by providing each team with professional tools suited to its specific needs and methodologies.
QPack is cost effective, easy to use and requires low maintenance. By using the requirements management tool QPack ALM package for software makes it possible to determine the precise feasibility of new functionality and see the impact of changes, all while taking into account the time constraints of release to market.

Using QPack test planning module allows the QA department to easily plan tests that automatically cover specific requirements planned for the release.   The test execution functions as a major part in the ALM process, allowing QA managers to execute testing activities for each release, by creating test execution sets and assigning them to different testers. This process enables the testers to run manual and automatic tests and allows tracking of test results and reported defects.

The defect tracking supports a vital part of the testing lifecycle. By using our software, your company benefits from improved tracking and reporting tools, all while maintaining correct version increments. QPack’s dynamic bug tracking allows managers to be updated on project quality on a continual basis.

QPack MSWord addon

May 1st, 2012 Posted by ALM 2.0 0 thoughts on “QPack MSWord addon”

QPack ALM system is seamlessly integrated with Microsoft-Word. In other words, you can create content such as system requirements document, action items, or detailed design in Microsoft-Word and seamlessly integrate it with QPack requirements tree.

QPack MS Word Integration Plug-in allows users to stay in the environment where they are most comfortable and where they work on a daily basis.

Example:

Activate the Word Add-on for MSWord integration by clicking QPack icon.

Make changes to your document such as adding new requirements

Select the parent requirment in QPack using the Word Plug-in, where this requirement should be added

The new requirement will be added in the QPack ALM requirements tree

User can make changes in your Microsoft Word document in offline mode, QPack MS-Word integration will easily sync the changes with QPack.

Microsoft MSWord Integration Features and Benefits:

  • Plug-in Toolbar: The QPack MS-Word integration Plug-in for MS Word Integration provides a QPack toolbar that can be uploaded to MS Word 2003/2007.
  • Simple Login: Users can log in to and log off the MS Word Plug-in via an icon on the Plug-in toolbar.
  • Sync with QPack: Easily sync Word documents such as system requirements specifications, change requests, action items and detailed design with QPack, by choosing the “Sync” in the Word integration.
  • Work Offline:  You can work offline with the Word document and later on sync it with QPack system.

June 12, 2012 : 5th Annual Medical Devices Software Development Summit

May 1st, 2012 Posted by Software Lifecycle Management 0 thoughts on “June 12, 2012 : 5th Annual Medical Devices Software Development Summit”

Accelerate your FDA/CE readiness and be at the market first !New ways and methods to get your product safer, your work done faster and reduce the operational cost by shifting your manual work onto new business strategy.

  • In this event you will meet top market leaders in the Medical Device industry.
  • Hear about customer’s experience with new information management technology.
  • Learn about making your first step into new era of software development for Medical Device

Register Here

Comply selected Orcanos QPack Medical ALM solution

January 2nd, 2012 Posted by Software Lifecycle Management 0 thoughts on “Comply selected Orcanos QPack Medical ALM solution”

Orcanos Welcome Comply,


Comply
 (http://www.comply.co.il/)  develops off-the-shelf specialized software products that provide a complete and integrated solution for the special Quality Management needs of the pharmaceutical, medical device and biotechnology industries. Comply helps ensure that your organization complies with regulatory requirements of computerized systems and improves your operations by providing expert consulting and specialized information systems.

Comply has selected Orcanos solution to support their product development which is stands for regulation and standard that needs to meet with 21 CFR Part 11 and other requirements. QPack system will support Comply change management process as well and will be producing all relevant document for Comply customers. At the same time Comply exposure to top industry Pharma suppliers now examine QPack support the validation procedure required by ISO 14971 for Computerized System, Information Technology and others. Having Comply under Orcanos list of customers serves Orcanos agenda in the past 4 year to be a leader solution provided for the Medical Device and aligned industries. We have been continuously working on QPack Medical™ to meet every change in authorization body requirements and standards. We are now moving forward with the Mobile Health changes and completing our product to allow small application vendors to be able to reduce the cost of compliancy by streamlining all the data under single repository – QPack Medical.

QPack Testing Tools 16 practical tips

December 13th, 2011 Posted by Requirements Management Tool 0 thoughts on “QPack Testing Tools 16 practical tips”

1. At least one test for requirement, maximize test coverage

2. Write functional tests first using QPack testing tools

3. Start with positive tests first using QPack testing tools – avoid subtle defects

4. Show test plan to developer to assure better coding

5. Use defects history for writing tests – better test management and monitoring

6. No more than 20 steps per test using QPack testing tools

7. Use QPack testing tools parameters to reduce test management overhead

8. convert defect to test case using QPack test management “convert defect to test case” utility

9. Use QPack testing tools workflow for test management authorization

10. Use test case effort estimation in QPack test management to assess the overall time required for test execution

11. Create execution sets for functional, sanity, regression tests using QPack testing tools

12. Use QPack testing tools test cycles management – run test case once in each cycle

13. Create reports using the test management filters utility

14. Learn to analyze your test management reports using QPack test management reports

15. Use clear defects description – QPack testing tool allows you to include test data in defect body when failing test

16. Use defects steps to reproduce in the defect to assure defect reproduce by developer

Orcanos ALM 2.0 Holistic

December 10th, 2011 Posted by ALM 2.0 0 thoughts on “Orcanos ALM 2.0 Holistic”

Application lifecycle management, ALM 2.0, becomes more and more crucial to project success as software becomes a major part of our lives. Lots of efforts are invested on quality improvements by the software vendors, in order to meet the increasing complexity of the software process and growing demand of end users. More and more high-tech companies use off shoring and outsourcing services, there is an increasing demand for compliance mandates by customers and the on going changes requires an efficient change management.

Read more…

QPack Medical Workshop For SMB

October 24th, 2011 Posted by Software Lifecycle Management 0 thoughts on “QPack Medical Workshop For SMB”

Orcanos has vast experience in escorting small-medium medical device manufacturers and 3rd party suppliers and assist in their development lifecycle management, including document generation to FDA/CE.

After QPack implementation, your organization will have the ability to manage the complete development lifecycle over QPack single repository, according to IEC 62304 and ISO 14971

–          You will be able to track and manage risk according to ISO 14971 (see GivenImaging risk management best practice: Risk Management Best Practice )

–          Requirements Management (Market, Product, Software, Hardware, Mechanic)

–          Test plan and execution including defect tracking

–          Change management

–          Document generation from QPack

–          Full traceability (System requirements->Software requirements, Software requirements->risk (mitigation), test case->Software requirement, etc…)

–          QPack validation

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