SOFTWARE QUALIFICATION & VALIDATION.


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Software Qualification Introduction.

This graphic depicts the Software Qualification logic flow path.

Software Qualification and validation starts with a user requirement document (URS).  When either management by policy; or an employee by cause; requests that a controlled process is instigated or an existing controlled process requires a serious modification (miner modification would be controlled under change control), a User Requirement Specification (URS) document is raised.  Over the course of several meeting the URS is fleshed out to document all aspects of the requirement. 

It is important that the document is properly scoped in order that the procurement, installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.

To scope and define an adequate validation procedure the URS has to be detailed sufficiently for various assessments to be made.  The main assessment that concerns us with software qualification AND VALIDATION is the risk assessment.  This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.

So at this early stage it is required to execute a risk assessment against the URS to see what category the software is going to be.

To learn more about this Validation Risk Assessment contents, click here;  VRA    

To purchase a ready to use Validation Risk Assessment document, click here;  VRA

It is a mandatory requirement that certain aspects of this assessment are documented and held as a regulatory required record.  These are;

Does the software require Full Life Cycle validation ?

Does the use of the software produce records that must comply with 21 CFR Part 11 ?

If the data requires to be Part 11 compliant, how is that to be being achieved?

The answers to these questions are required to enable the Validation Plan (VP) to provide sufficient information to the protocol writers, to enable them to define the correct content for the Installation Qualification (IQ). Operational Qualification (OQ) and the Performance Qualification  (PQ) protocols.  

The VP is then used by the protocol writers as the official mandate for protocol content 


Full Life Cycle (FLC) or Standard Validation.

This graphic depicts a Software Qualification data flow diagram.

The outcome of the VRA drives a split in software validation scope, if the VRA categorises the software as requiring Full Life Cycle Validation (FLCV); then a considerable amount of the validation effort is put into establishing how the software originated, was designed and developed, in order to establish that its basic concept and development can be considered robust, sound and in accordance with best practices

The original development plans, code reviews, methods reviews and testing plans must be available to enable this software qualification to be executed successfully.  Once this proof of quality build is establish, validation then follows a more convention path in code / procedural / security verification / functional inspections and verification.

Software that is not classified as requiring FLCV treatment, does not require this depth of verification into quality build history and is validated mainly by the more convention path in code / procedural / security verification / functional inspections and verification.


FDA Expectations are:

Quality should be built into the product (must be documented0), and testing alone can not be relied upon to ensure product quality.


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Software Qualification and Validation Testing.

Dynamic Testing.

Dynamic testing verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software qualification and validation testing against these tests. The results are then compared with expected or known correct behavior of the software.  Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis. 

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods. One such method is static analysis. This somewhat new method largely automates the software verification process.  The technique attempts to identify errors in the code, but does not necessarily prove their absence.  Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification.

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the FDA and some segments of industry recognize the value of sound verification principles and are using tools based on these principles.


Software Uses.

Artificial intelligenceComputer algebraMathematical problemsComputer architectureComputer graphicsComputer networksComputer programComputer programmingComputer securityDatabasesData structure, Distributed computing, Information retrieval, Programming languages (languagesProgram specificationProgram verificationdebuggingRobotsSoftware engineering.


FDA latest guidance on 21 CFR Part 11.

Schematic diagram for software qualification data flow.

It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated.  So we have incorporated the guidance suggestions in their latest guidance document, into this Validation Risk Assessment (now issue 10).  This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments.  This is now a mandatory requirement. 

Part 11 will be interpreted narrowly; we are now clarifying that fewer records will be considered subject to part 11. (extract from FDA document) 

This would appear to mean that the original all embracing approach to all electronic records is to be dropped and the rigors of part 11 applied only to the data that directly affects product quality and safety, and record (of the product) integrity. 

For those records that are to remain the subject of part 11, we will apply discretion in the validation of audit trails, record retention, and record copying.  (extract from FDA document) 

This would appear to mean that if your in-house document control is secure and robust; then it will be acceptable in the matter of audit trail / record retention and record copying.  

We will enforce all predicate rule requirements, including predicate rule record and record keeping requirements. (extract from FDA document) 

This is a statement to the effect that in all other ways 21 CFR Part 11 will be enforced. 

Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).  (Extract from FDA document )



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