The FDA requires that U.S. life sciences companies validate all computer systems that can affect product quality or consumer health. This computerized system validation process involves demonstrating and documenting that computer systems are performing as expected per a set of defined requirements. Through computer system validation, life sciences companies can establish a good practice (GxP) approach to reduce risk and ensure products are being consistently produced according to high quality standards. Digesting the FDA’s vast amount of guidance on this topic can be a formidable task, so it is highly recommended to choose an experienced computerized system validation partner who can help you navigate this complex yet critical area.
Here are some of the key aspects in choosing a validation partner:
- Does your GxP validation partner have a deep familiarity with guidance documents such as ISPE’s GAMP5 risk-based approach to GxP computer system validation?
- Is your GxP validation partner familiar with the FDA’s Title 21 CFR Part 11 regulations on electronic records and electronic signatures? Title 21 CFR Part 11 defines the set of controls under which electronic records and electronic signatures can be considered the equivalent of paper records.
- What is the time-to-implementation commitment from your partner? Does it take months, weeks or days to get started?
- What are the recurring costs? Do they have a plan if work grows beyond the scope in the SOW?
- How about scalability? Is your partner equipped with extra resources that are already trained on computerized system validation?
Through addressing the points listed above, a potential computerized system validation partner will be well-positioned to help you develop a high-quality validation process. For more details about vendor assessment, feel free to schedule a free consultation session with our team at Prana Life Sciences.
Also Read,
