Training Doyens

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...