Data Integrity

Data integrity within a CGMP environment is defined as “the assurance that data records are accurate, completed, intact, and maintained within their original context, including their relationship to other data records”. This requirement applies to paper, electronic, and hybrids of both electronic and paper records to ensure that data is reliable, true and accurate. The FDA and other regulatory agencies …

Data Logging & Mapping

We have all bought something that didn’t quite work the way we wanted. We get home, we set it up, and in the end, we get a dose of disappointment. Hopefully it can be returned and all we have wasted is time. However, in the world of compliance, a piece of equipment that does not work the way it needs …