Computer system Validation

Good Documentation Practice Basic Concepts of Good Documentation Practice in Pharmaceutical Industry     Why Document? In the pharmaceutical industry it has been said that, “If it isn’t documented, it didn’t happen” Therefore, in the pharmaceutical and medical device industry, we document to provide written proof that something happened. What is Good Documentation practice? Good Documentation practices are the guidelines which one follows in recording raw data entries in a legible, traceable and reproducible manner. Good Documentation Practices are commonly referred to as GDPs. Change Management!!! “A systematic approach to proposing, evaluating, approving, implementing and reviewing changes.” All changes should be formally requested, documented and accepted by representatives of Production, QC/QA, R&D, Engineering and Regulatory Affairs as appropriate. The likely impact (risk assessment) of the change on the produ