Category: Validation

Audit Trail Reviews for Data Integrity Audit trail is a record of the “who, what, when, and why” of a record. Data integrity arrangements must

Data Integrity Data Integrity is not a new requirement in medical device and pharmaceutical industries – it features heavily in Chapter 4 of the EU

Dry Run Dry Runs are often misunderstood. While they can be of huge benefit to a project, time and again they do not get factored

Good Automated Manufacturing Practices GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International Society for Pharmaceutical Engineering