Subject matter experts (SMEs) are considered to be those individual stakeholders in a computer system who contribute their technical expertise to the system validation effort.  Among the SMEs are system software developers, infrastructure support providers, process engineers, process owners and others who share in the responsibility for design and configuration of the system.

Our first bit of advice to the SME is to keep it simple.  Focus on the direct solution to the critical needs of the business process.  Stay within the scope of the plan laid out in the user requirements as documented by your business analyst.  Avoid the temptation to overdesign the system by including functional features that add to the complexity of the system.  Unnecessary “fluff” or “bells and whistles” only add to the burden of development, documentation, and testing without adding any real value for the cost. Just because it can be done does not always mean that it should be done.

Stay in continuous communication with your team of system stakeholders.  This will prevent the direction of development from straying “off into the weeds”.  Elicit feedback from your business process owner(s) and/or business analyst at regular intervals to ensure that the system meets the requirements for its intended use and aligns with the intent of the documented user requirements.

Engage your validation representative or service provider regularly throughout the development process to promote a joint consensus of the validation and compliance implications of the system design decisions.  This will also ensure that traceability is maintained between user requirements and the specified functionality of the system. This is often an iterative process, and updates to requirements to be expected. Additions and changes to requirements and specifications should be documented as the as the decisions are made.

Document as you go!  Work with your validation representative or service provider to maintain ongoing development of specifications in tandem with the system design and development process.  This best practices should be integrated into your development methodology. Creating documentation retrospectively, once system functionality and configurations are fully developed, is a time consuming process that creates unnecessary burden on the project’s budget and schedule.

Ensure that careful considerations are made in the design of your system to enforce proper compliance with regulatory requirements for use of electronic signatures, electronic records, and data integrity.  System security should be configured to limit access to system functions and data records to only those users who have need and authorization to create or modify specific data records on the system. Employment of electronic signatures and system logons must ensure that each username/password key is directly attributable to an individual user and cannot be shared among multiple users.  Permissions should be granted at group levels that reflect the training level and responsibilities of individual job titles associated with the business process. Wherever possible, leverage the software’s audit trail functions to track the “who, what, and when” of any user actions or record modifications. Protect electronic records from deletion and undetected alterations.

Test as you go!  Incorporate component testing into your development methodology.  Work with your validation representative or service provider to implement a sound practice for documenting your component, module, or unit testing for all critical components as well as non-critical components.  Documentation of non-critical components testing can be leveraged to reduce the amount of testing that will need to be done under formal qualification protocols. Documented testing of critical components during the development stage will expedite the drafting of test cases for the formal qualification protocols. Component testing will also reduce or eliminate the incidence of system related deviations during execution of formal qualification testing. Keep in mind that once the system is locked down in a controlled state for qualification testing, the cost and effort required to rework the system and formally resolve the deviation is exponential to the cost and effort involved in discovering and correcting a system failure or discrepancy in development.

Be prepared to support the development and  execution of formal qualification testing. While the execution may be undertaken by your validation representative or service provider, your input and expertise will be indispensable to the successful outcome of this process.  Your input and clarification of details toward the development of the testing protocols will be invaluable for ensuring that test steps and expected results are accurate and viable, minimizing or eliminating the potential incidence of test script related failures and deviations during execution.  

If you are the system developer, you may be asked to participate in the review of custom code prior to initiation of qualification testing, and provide documented evidence of system configuration in the installation qualification phase of testing.  If you are the system administrator, you may be asked to configure a set of test user accounts and provide test data records or audit-trail data in support of testing. At any point in the execution of qualification testing, be prepared to support the resolution of system related failures and deviations by determining root cause and corrective actions.

About Performance Validation:

Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers. Have a question on Commissioning, Qualification, Validation please use our contact us form.

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