Setting Realistic Timetables For Deviations, Complaints, And CAPAs

By Rosario Quintero-Vives, Senior Regulatory and Compliance Specialist, RQV Consulting

Priorities are important to have in any environment, and regulated environments are no exception. When you are planning your quality system, you must keep your priorities top of mind; otherwise, regulatory agency visits could end in trouble. When you establish timetables to address any deviation of procedure, product complaints, or even CAPAs, you have to plan realistically — or you will put yourself and your business in a very tight position. Prioritization is critical because it can be difficult to remediate too many observations at once while you are still in production.