AUDIT TRAIL REVIEW FOR DATA INTEGRITY: CRITICAL QUESTIONS YOU MUST ASK TO ENSURE YOUR COMPANYS SYSTEMS STACK UP TO FDA GUIDELINES
Audit trail is a record of the “who, what, when, and why” of a record. Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. How does your Company’s systems stack up to this FDA Guideline?
In this post we explain the fundamentals of Data Integrity via the acronym ALCOA+ that defines the framework required to achieve and maintain Data Integrity.
Dry Runs are often misunderstood. While they can be of huge benefit to a project, time and again they do not get factored into the testing schedule, and so, they can become a ‘nice to have’ rather than a mandatory part of the testing cycle.
GAMP – Good Automated Manufacturing Practices was founded in 1991 and is a trademark of the International Society for Pharmaceutical Engineering (ISPE). GAMP-5 was launched in 2008 and includes a set of procedures that help to ensure automation equipment/software meets required quality standards.
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