A NEW APPROACHManufacturers must address the following issues to ensure improved compliance:
One new approach to improve compliance is to plan for validation before the facility is designed and to implement a modular validation platform when building a facility. This involves thinking about validation holistically without simply launching into the development of a detailed and comprehensive validation master plan (VMP) from the outset. Manufacturers currently believe that such master plans must be compiled at an early stage. However, this adversely affects a validation project because the VMP is a large, inflexible document that requires constant revisions and rewriting during the course of the facility build, resulting in delayed go-live dates and product manufacturing.
A modular program sets out broad intentions and observations in high-level policy and master-plan documents that can be readily adapted as the facility design and construction progresses. This allows specific details to be built into the modular plan as the project evolves and provides more efficient compliance with full traceability back to the initial development and user intentions.
Moving away from traditional approaches to facility validation doesn't involve reinventing the wheel, but will help manufacturers achieve efficient and well-planned validation, allowing greater regulatory compliance; increased standardization of protocols and documents; and better employee appreciation of the processes involved.
With rising costs, a changing regulatory environment, and the availability of improved approaches to validation and document management, now is the time for manufacturers to review facility validation procedures and establish effective platforms. Implementing a modular approach will accelerate the time it takes to bring a facility online by eliminating unnecessary validation while ensuring that the work required is performed and documented correctly and accurately.
Victor Bornsztejn is the global growth director and Brian Collins is the validation program director at GE Healthcare Services, Piscataway, NJ, 732.457.8056, [email protected]