Finding an effective and fully compliant change management system that works is not easy. And yet, regulators look for one. Here are a few tips from Peter Smith, in Strategic Compliance Consulting at PAREXEL International, on how to deal with common change management problems such as assessments and documentation of the change. Smith is a former senior official with FDA.
For starters, do not use “planned deviations.” Many companies use the erroneous concept of “planned deviations,” which are not deviations at all, but rather, changes. These changes are often temporary and handled within the deviation management system or similar program. Deviations are unexpected events wherein some control is lost and the product quality impact of the event must be evaluated retrospectively. No one wants to “plan to deviate” and deviations raise a red flag to regulators…. Read the rest of the answer in the June issue of PharmTech.