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The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
On April 12, 2017, the International Society for Pharmaceutical Engineering (ISPE) announced the publication of ISPE GAMP Guide: Records and Data Integrity. The guideline addresses how companies can ensure data and record integrity in a regulated industry and includes concepts such as risk management, data governance, data lifecycle, and ALCOA (attributable, legible, contemporaneous, original, and accurate). Data integrity violations have been a focus for FDA recently, resulting in several FDA warning letters sent to pharmaceutical manufacturers.
The new guide is aligned with ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems and was developed by ISPE’s GAMP Community of Practice, which is comprised of practitioners and subject matter experts with more than 25 years’ experience in developing guidance on risk-based approaches. Regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency and the World Health Organization, also provided input.
“This new guide describes the data lifecycle, and was intended to be used along with GAMP 5, which describes the system lifecycle,” said Mark Newton, associate senior quality assurance consultant, Eli Lilly and Company, in a press release. “Together, they provide a comprehensive overview of concepts necessary to create data with integrity and quality. The elucidation of the data lifecycle, a maturity model, and the great appendices make this guide different from other data integrity publications to date.”