As part of the evolving data integrity focus, regulators are closely examining software systems. In particular, auditors are looking for instances where software configuration and use may create data integrity issues. Confirming that a lab’s software configurations do not create data integrity risks is an essential part of computer system validation
How this new focus impacts your lab?
Past audits may have looked for evidence of data integrity breaches. The current trend is for auditors to look at the “opportunity component” of Cressey’s fraud triangle—specifically, does the configuration prevent breaches? If your lab receives an FDA Warning Letter citing one of your computer systems, the remediation requirements will likely expand to include all of your systems.
For these reasons, computer systems must be validated for intended use, which is how the software is configured to meet regulatory requirements. That way, any deficiencies and risks will be documented (and corrected), and your lab can avoid the costs associated with regulatory action.
Software validation requirements are based on two primary approaches:
- GAMP 5—the risk-based approach and associated V model
- Electronic Records and Electronic Signatures (ERES)—21 CFR Part 11 for the U.S. and equivalent requirements for other regulatory agencies (such as Annex 11 in Europe)
What about computer system validation (CSV)?
Computer system validation (CSV) ensures that the intended workflows, including software use, are rigorously tested to identify and correct any issues. Although required for pharmaceutical and other regulated industries, it is often perceived as a cost that can delay implementation of essential new software.
By partnering with Agilent and applying Agilent CSV starter kits—which are based on the GAMP 5 model—your lab can save both time and money. In fact, an Agilent CSV starter kit can reduce implementation time by 50% or more, leaving you with more time for scientific analysis.
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