The Connection Between Data Integrity and Computer System Validation

Margaret Blackburn, PerkinElmer, Charles City, USA (margaret.blackburn@perkinelmer.com)

Data integrity applies to all regulated environments. Understanding which regulations are applicable will help drive compliance for laboratories. Key fundamentals of a compliant space include basic good documentation of all data. GDP, good documentation is the foundation of data integrity. The importance of DI in a regualted space allows the trusting of all data and what it represents. The FDA defines data integrity as all data being complete, consistent and accurate throughout the data life cycle. Regardless of data being paper or electronic, DI is expected and enforcable.  As technologies advance and companies partner to grow, there is an increase in the number of DI violations seen by the FDA. The increase in DI violations are seen as a result of the increase in the warning letters and 483's issued globally. In 2017 of the 82 warning letters issues, 68% had a DI component. Many of the violations stem from 21CFR Part 11 which was put into the federal registry in 1997 and contains the regulations pertaining to electronic records and signatures. While the regulations on electronic signatures is well understood, regulations surrounding electronic records still leads to confusion. Computerized system validation many times is a source of this confusion. Understanding that validation is not a one-time event for laboratories and that validation must be complete in order to satisfy the regulators is a lesson being learned by many in the industry now. Linking CSV and DI together provides an understand of the importance of the validation and how it justifies and demonstrates compliance to DI in the regulated environment.

             

 

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Short Biography of Presenting Author

Margaret Blackburn is a CQA certified Quality and Compliance veteran in the industry with over 17 years of quality auditing for both internal and external regulatory inspections. Her background is developing and implementing quality systems that are the right fit for a company, writing quality manuals, validating instruments and clinical methods, developing quality procedures and policies that re aligned with cGXP, and cultivating a quality atmosphere not only interdepartmental but company wide. She has participated in working groups for CPT code approvals through the AMA, managed product lines of novel tumor markers, and served as SME for beta site testing and new site implementation of the product. Her experience in industry ranges from Quality Directorships and Chief Compliance Officer to Product Manager for an international medical device company, blood banking, national reference laboratories, biotech, CRO, BSL3 companies. Margaret is currently the Global Lead of Compliance for OneSource.