Software Qualification Protocol 4740

How to write a superb software qualification protocol by editing our interactive and intuitive template produces fast cost effective results. 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 template 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 qualification is going to be.

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 Validation Plan be being achieved?

The answers to these questions are required to enable the  (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 

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The outcome of the VRA drives a split in software qualification template 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 qualification template 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 validation template to be executed successfully The basic method of how to write a superb software qualification protocol must be mastered.  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. As detailed in the Software Qualification template.

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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 )