Setting inappropriate Alert and Action alarms on your Environmental Monitoring System (EMS) could be a big contributor to lost revenue, longer downtimes, and a lot of discarded products. Misinterpretation of cGMP guidelines and an inadequate approach to the use of your EMS alarming functionality may set you up for failure right from the start.
By partnering with the right EMS supplier you can have a major impact on your manufacturing process, product revenue and regulatory approval process. Installation and proper use of an EMS depends on investing in the right supplier and on them having adequate resources to assist in maintaining the system and providing the right technical support required to enable business continuity. PICs GMP Annex 11 Computerized Systems discusses the need for a strong vendor partnership and ongoing support. So selecting the right supplier will assist in a monitoring system working for you and not against you.