This webcast features: Martin Laferriere, Director, IT Systems Compliance, Avid Bioservices
Software systems risk management and evaluations should be part of your validation process. It is possible to reduce testing by documenting your risk, actual use, regulation impact, evaluating vendor(s), etc. The approach to managing the risk evolves through audits and prior experience and can tailor the management and approach to system quality within each organizations. In my experience and observations, an efficient system risk management is essential, and it can change wildly throughout our industry. Finding the right fit for your organization is essential: how much risk are you willing to take, how much documentation are your business owners prepared to embark into before the system is implemented, and how much testing are you willing to do if they don’t?
It depends on the size and specialization of your organization: from Big Pharma where it’s possible to plan well in advance and employees in the chain have specialized responsibilities, to smaller companies where more multi-functional employees and a more flexible process is required.
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