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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