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Challenge #1: Internal versus SaaS-based validations A typical audit assesses their quality system, including training programs, customer support, data center, and computing environment.
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The vendors should be able to deliver very robust and strict document control on software development lifecycle (SDLC) methodology, project planning, design and programming standards, configuration management, testing standards and procedures, and others. Vendors should be held to high quality standards and there are numerous things you should assess when auditing a vendor: what types of methodology do they use? Are standard coding terms and personnel qualifications used? How do they manage documents and procedures? What methods do they use for review and approval?ĭevelop an audit plan and scope of activities that outlines the documents that will be reviewed and activities that will be evaluated. Note, vendors should be qualified throughout the lifecycle of your system. It is also important that the vendor is available in the event of an audit so that they can assist if any questions arise that would pertain to their documentation.
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In this case, the vendor audit should be referenced in your validation plan to justify why a full IQOQ was not performed. Qualifying vendors longer than this timeline, eg, every 5 years, should only be considered for vendors that are standardly used in the regulated industry space. If the vendor has less robust processes or has a homegrown system, an audit can be done yearly to make sure they are keeping up-to-date with quality practices. You will need to evaluate all their processes for quality management according to your expectations and any formal audit procedures.ĭepending on the risk of the vendor, eg, how good are their quality practices, this can be done as a 1-day audit every 2 to 3 years if their practices are robust. However, it is standard to audit the vendor’s procedures and software development lifecycle to ensure it meets your company’s quality standards. Relying on vendor experience can minimize the need for a client to “retest” the software core functionality. This reduces some of the validation burden on companies since they can now partner with vendors and leverage their knowledge, experience, and validation documentation. One of the more important features of GAMP 5 that is unique to prior GAMPs versions is that it allows you to “partner” with vendors and, in turn, leverage supplier involvement. Source: GAMP 5-A Risk-Based Approach to Compliant GxP Computerized Systems. Upon release to Operation, the system is monitored, applying any changes using change control through system Retirement. The lifecycle of a computer system is comprised of different subprojects within the lifecycle phase: in Concept, assessments are done, validation plans are developed, scripts are written, and governance processes are formalized. GAMP 5 not only provides a rich resource of information for computer systems, electronic signatures, and software development lifecycles, but also provides a risk-based approach and guidance on all validation issues. The current version, GAMP 5, is followed by most validation personnel in regulated industries such as pharma and biotech. To that end, Good Automated Manufacturing Practice, GAMP ®, is an industry guideline that provides a risk-based approach to compliant GxP computerized systems. This may result in more validation being performed than required. The regulation is very broad and can be interpreted in several ways.
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The FDA Code of Federal Regulation (CFR), and specifically 21CFR11, provides not only guidance for validation and testing, but also for other important criteria such as record protection and retention, system access limitation, operational system and authority checks, personnel qualification, system documentation, and audit trails. Regardless of expertise, validation has pitfalls and challenges and is resource intensive. These clients possess a range of experience in software validation-from those who have internal resources who are very familiar with regulatory requirements for software validation to small companies who need more support and external expertise. As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries.
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