Data Integrity Practices for the Laboratory and Beyond

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.

In this 90-minute accredited training, we will discuss effective batch record review. 

THIS TRAINING IS PART OF OUR GMP LABORATORY CONTROL PROFESSIONAL CERTIFICATION

• To enroll into the complete GMP Laboratory Control Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications 

​To register for this individual course ONLY, click the Register Now button below.