Validate software according to FDA 21 CFR Part 11 with QPack

Using software system  in the medical device development process requires compliance of software systems with the  FDA 21 CFR Part 11 regulation.

Section 21 CFR part 11.10 requires to "employing procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine."

Also part 11 requires the "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."

QPack support for 21 CFR part 11 validation process:

- 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 subjected to part 11 ruling 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.

  

  

  

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

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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.