Training Doyens

OVERVIEW Data integrity is the assurance that data records are accurate , complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current  Good Manufacturing Practices (CGMP)  for  US Food and Drug Administration (FDA)-regulated   industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale. WHY SHOULD YOU ATTEND In recent years,  FDA  ha...

Data integrity is the completeness, accuracy and consistency of data, regardless of the format in which it is generated, retained or used.  Maintaining the integrity of data pertaining to GMP activities is very important for maintaining compliance with the regulations. Best practices for maintaining data integrity not only encompass the Quality Control (QC) data but also the data which is generated by other activities like manufacturing, validation, packaging, materials management, facilities management and more. An effective way of maintaining data integrity involves risk-based and holistic assessment of the systems that store the data related to GMP operations, and include manual, electronic and hybrid systems. Here are some of the best practices for maintaining GMP data integrity: Understanding Part 11 Requirements The first step of working towards data integrity includes identifyingand understanding the Part 11 requirements applicable to electronic records and signat...