Understanding Risk Management
Computerized systems have become a part of almost every aspect of laboratory activities and regulated companies are, therefore, making great efforts to raise their level of compliance with both the regulatory requirements and the expectations of governing agencies. However, companies often end up creating quality systems and mechanical processes that are too rigid for efficient Computer Systems Validation (CSV). This limits their ability to practice the more modern and FDA preferred risk-based compliance methodology. A risk-based compliance methodology delineates clear responsibilities, processes, and documentation requirements that increase the level of compliance while generally reducing the CSV effort and cost. [ Read more ]
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CSols, Inc.
Informatics Insider
www.csolsinc.com/blog
