We have found that the PerformOEE™ product is in full compliance with these regulations and can be validated by our customers to assure compliance.
The findings of the compliance audit can be found in the “PerformOEE™ - 21CFRPart11 Compliance Validation” document.
This document will fully support the implementers and users of PerformOEE™ in certifying to the regulatory authorities how PerformOEE™ complies with the regulations and agency guidelines.
However, it is important to understand that a successful 21CFR Part 11 compliant installation of the PerformOEE™ software requires shared responsibilities.
OEEsystems aim is to provide our customers with the technical means and system implementation experience necessary to ensure that our applications fulfil the requirements of Part 11. There are certain “limitations” which apply to both parties, but OEEsystems will endeavour to provide a system that can be managed with relative ease in order to meet FDA rules and guidelines.
