![]() ![]() ![]() FDA Guidance on Part 11 Scope and Application states - We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.The CSV course Computer System Validation - Reduce Costs and Avoid 483s will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Ĭomputer system validation is a regulatory requirement.Understanding the computer system can help regulated companies, software vendors and Saas/cloud providers. Therefore regulated companies that outsource must ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters. Software vendors who provide Software as a Service (SaaS) and cloud computing IT resources are not regulated. A consistent process to validate these systems is invaluable to companies who use COTs software The commercial-off-the-shelf (COTS) software developed and supplied by software vendors must undergo validations by end users. Software vendors design and develop systems to ensure they meet the industry standards. The regulated industry has developed requirements and standards for managing systems and processes related to product design, development, manufacturing, packaging, distribution, and monitoring. ![]()
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