ISPE releases guide to data integrity

Data Integrity by Design is aimed to form a bridge between the company’s pre-existing GAMP guides

The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest GAMP RDI good practice guide: Data Integrity by Design. This guide was written by a group of experts and reviewed by regulators and practitioners in the field. ISPE says it supports a holistic data integrity approach using data governance and knowledge management activities.

The guide provides a bridge between the system lifecycle approach defined in GAMP 5: A Risk-Based Approach to Compliant GxP Computerised Systems, and the data lifecycle approach in the GAMP Guide: Records and Data Integrity. Data integrity can only be achieved, ISPE says, when both lifecycle approaches are adopted, understood, and actively managed.

Several additional areas are covered in this guide’s appendices, including knowledge management, instrument devices and an appendix on computer software assurance (CSA) that details CSA key concepts and provides illustrative case studies.

“Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation and retirement of computerised systems supporting that business process,” said Lorrie Vuolo-Schuessler, Guide Co-Lead, Senior Director Computer Systems Quality and Data Integrity, Syneos Health. “It promotes the application of critical thinking to identify how data flows through the business process and to proactively assess and mitigate risks across both the system and data lifecycles. It emphasizes data integrity as foundational to protecting patient safety and product quality.”

“Computer Software Assurance was born from US FDA CDRH’s Case for Quality which treats compliance attainment as the baseline and promotes the inclusion of critical-to-quality practices that result in improved quality outcomes,” said Charlie Wakeham, Guide Co-Lead, APAC GxP Compliance Manager, Waters Corporation. “An industry team was formed, and work begun on the development of an FDA Draft guidance to apply this paradigm to computerised system validation (CSV). In an industry first, members of this CSA team have collaborated closely with GAMP subject matter experts to create an appendix to the Data Integrity by Design Guide detailing the key concepts of CSA and providing illustrative case study examples of its application.”

“As with all GAMP guides, the content has been written by active industry personnel, passionate about patient safety and improvements to the regulated industry, who have experienced the problems, the issues, and the pain in their day jobs,” said Jim Henderson, Guide Co-Lead, Business/Computer System QA, Eli Lilly and Company. “This elicits a level of practicality and detail in the guidance that allows the reader to readily apply the guidance to their own organisations.”

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