Multiplexing Laboratory System CSV

The Challenge

A leading health care research laboratory contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for a multiplexing laboratory system.  This system is used to perform quantitative analysis of proteins and nucleic acids in a variety of sample matrices for their clients.  The instrument and its data acquisition / analysis software was purchased to increase productivity from their previous system and to allow them to conduct Good Laboratory Practices (GLP) compliant studies for their clients. To bring the system into GLP compliance, the system required validation. Performance Validation was contracted to validate the system in time to support an audit by the research laboratory customer. Successful completion of this audit is a precursor to project award to the research laboratory.

The following validation project considerations were identified for the client and their commercial-off-the-shelf (COTS) instrument / software:

• Bringing the system into GLP compliance on an expedited timeline without significant in-house validation procedures or plans implemented
• Evaluation of the software vendor had not occurred
• Evaluation of 21 CFR Part 11 compliance of the software or the laboratory procedures had not occurred
• Minimizing impact on the stakeholder’s production responsibilities

The PV Advantage

The PV team on this project had years of experience in GLP laboratory compliance and validation which contributed to an expedient and comprehensive validation. PV immediately began work prior to being onsite to expedite the project launch.  This was followed by onsite support and collaboration with laboratory stakeholders to complete the validation.  The following components detail the PV solution:

1. Vendor audit questions were compiled and sent to aid in evaluating the vendor for risk and quality to incorporate into testing strategy. After receiving input, a Vendor Evaluation Summary Report was generated indicating the vendor as a low risk provider.
2. A User Requirements Specification was created by gleaning possible user requirements from the user manual for the software and hardware page-by-page.  Then, the requirements were further developed and refined through partnering with the laboratory project stakeholders.  The team focused on the intended use and GLP applicability of the system.  This proved valuable as test script authoring commenced, the stakeholders could either assist in writing tests or delete requirements.
3. A 21 CFR Part 11 compliance assessment was created.  PV understood the regulations, the FDA Guidance, and the preamble requirements.  This assessment outlined areas of the software that needed to be addressed with a procedure (i.e. gaps) and was also used to create user requirements. Guidance was given to ensure the client satisfied the FDA’s requirement of using electronic signatures as the equivalent to an actual signature during data collection. A summary of how the gaps were addressed was also generated to include with the validation package.
4. A Validation Plan was created to outline the planned validation deliverables and the strategy for testing the system.  It leveraged the favorable vendor audit and low risk score from the ISPE’s GAMP 5 risk and complexity approach.  This evaluation determined the combination of simple complexity, along with the high detectability and low probability for issues would allow the team to use a risk based approach to maximize efficiency and ensure compliance.
5. PV sent a team member out to the clients’ location to finalize documents and create test scripts.  These test scripts were generated as early as possible to give the tester time to practice execution and allow for quality reviews prior to official execution.
6. The PV team member executed some testing and provided guidance and review for the remaining user acceptance scripts to ensure expedient execution.
7. PV provided consultation on the laboratory’s existing Standard Operating Procedures (SOP) applicable to the support and use of the system and assisted in the creation of a new system specific SOP. This collaboration with the laboratory stakeholders helped ensure the timeline remained on track as well as satisfied the applicable regulations.
8. A Requirements Traceability Matrix was created to document where each user requirement was satisfied with testing or vendor documentation.
9. The PV team member made extra efforts for the documentation to match the clients format as well as cover all validation details by creating a change control form, deviation form, a validation team record, access control log, a binder cover and spine label, printed label tags, and a release to production memo.
10. PV provided regular project status updates which provided details on the project deliverables, project budget, and risks to the project and schedule.
11. A Validation Summary Report was generated explaining all the validation deliverables and how the clients’ documentation satisfied regulatory requirements.
12. PV provided the client final steps necessary to implement the system into production GLP use to ensure successful implementation for a scheduled future audit.

The Results

The multiplexing laboratory system validation was completed ahead of schedule meeting the customer’s overall system implementation deadlines.  The validation effort brought the system into compliance with all applicable regulations through excellent documentation standards, testing processes, and a focus on the customer needs.  The documentation maintained clarity and transparency critical to delivering documentation that stands up to audits by regulatory bodies such as the FDA. Business process and regulatory requirements were equally emphasized and constantly considered.  The team met its professional goal to provide the laboratory client peace of mind by breaking down the necessary compliance regulations such as 21 CFR Parts 11 and 820 into manageable pieces for creating a compliant system.

Update 3-24-14; The validation of the instrument was successfully audited by a third party auditor which resulted in no identified citations.  This is the first zero citation audit experienced by the client.

 The Benefits

Performance Validation provided the client validation project execution and consultation through understanding the project, the stakeholders and their needs, and the best fitting validation strategy for a laboratory instrument.  The validation documentation focused on efficiency due to the time constraint and worked with the Information Technology, Quality Assurance, Subject Matter Expert, and Application owner to ensure responsibilities for each document were clearly outlined at every step in the project.  The Client was provided a recommendation to create a Validation Master Plan to outline their procedures for validating systems as well as keeping current validated systems in compliance. Performance Validation will continue to support the system beyond go-live in the event of auditing questions or change controls.

For more information please, schedule a call with one of our subject matter experts. 

Kevin Marcial,
CSV Services Manager