Pharmaceuticals

The pharmaceutical industry is one of the most heavily regulated industries served by EAM vendors.  Maintenance and facility managers at pharmaceutical manufacturers must struggle to interpret and comply with Good Manufacturing Practice (GMP) requirements and FDA 21-CFR-11 guidelines.
 
Implementing EAM in such a heavily regulated environment should be done with the assistance of someone who has traveled the road before.  Must-have functionality such as Audit Trails, Electronic Records/Signatures, Security Profiles, and the like are considered high end functionality by EAM providers and are not to be implemented without a full understanding of the client's business processes and requirements.  Any software implementation must be accompanied by exhaustive and accurate documentation of the software package's Installation and Production Qualification (IQ/OQ) detail.  Validation of the software must be performed, ideally prior to commissioning, but sometimes in a retroactive fashion.  Avoiding costly penalties from the FDA is a given, and Stratum Consulting Partners can help you confidently deploy EAM in your production environment.