Tuesday, June 30th, 2020
Data integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle. It is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.
Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and data disposal after the record’s retention period ends. System design and controls should enable easy detection of errors, omissions, and unexpected results throughout the data’s life cycle.
In this webinar, data integrity requirements for filter integrity test instruments will be discussed and demonstrated, with specific focus on: static electronic record, electronic audit trail of relevant GMP parameters, access control, data backup and data transfer.