The definition of the words pharmaceutical validation means ‘the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.’
In the Pharmaceutical industry the importance of the pharmaceutical validation process consistency for product compliance is critical. This therefore involves strict monitoring of a products environment throughout manufacture and how that data is stored and reported.
The qualification of equipment such as environmental monitoring systems and software is a must and users need to ensure the system they purchase is put in place using strict installation and operational qualification processes provided by the supplier. The resulting completed validation documentation provided to customers will go on to satisfy auditors time and time again.
But be warned, what you can get from other suppliers offering validated systems surprisingly varies and may not be up to scratch.
We recommend you contact us to determine exactly what is involved when validating a system, whether you choose to buy from us or not so that you know exactly what to expect. When validation is concerned you cannot afford to take a risk.
The IMC Group has produced a fully validatable environmental monitoring system in line with pharmaceutical organisations for over 15 years and they continue to meet the strict requirements set out by FDA 21 CFR Part 11.
For a fully validated compliant system supported by robust IQ and OQ protocols you can trust, contact the experts here at the IMC Group. We would be happy to talk you through how we differ from other suppliers on market. Contact us today.