By Chris Seifarth, Director, Client Solutions.
Managing inspections is one of the most challenging requirements across the life science industry today. Many companies struggle with developing internal capabilities and infrastructure for proactively managing inspections and the remediation of observations. Contributing factors include lack of resources, evolving regulations, lack of experience and inconsistent or limited standards for early and on-going assessments, for managing, identifying, and addressing quality, risk and performance.
So what can companies do? Utilize a post inspection tool kit to:
- Change mind-sets
- Evaluate the preparation for the inspection
- Improve and develop teams
- Develop a Remediation Play Book
Ultimately, the best way to survive any inspection is to always be ready for it. As part of any Inspection readiness program, using risk assessments, quality gates, and training at multiple points in time across the lifecycle of the program to ensure all employees are aware of inspection procedures, what items to have ready during an inspection and how to interact with inspectors.
For more information on the post inspection toolkit, published in the April edition of the Research Quality Association (RQA) magazine Quasar, contact email@example.com.
Quasar is published quarterly and is provided free to members.
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