The FDA requires that software systems used for quality purposes in place of paper records be validated for their intended use [Title 21 CFR Part 820.70 (i)]. This means that when using configurable off the shelf (COTS) systems, companies must verify that the software is configured correctly to meet their business needs. Even if you are intending to do a relatively vanilla implementation you need to have documented evidence verifying that the system was correctly installed and configured correctly.
The following is a list of many of the services provided by PGTS:
The key to our service is that we bring a commonsense approach to every project we are a part of. At PGTS we want to be your documentation resource, not your one time connection.
Penny Goss Technical Solutions