|Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful audit or inspection for any GMP regulated quality control laboratory.
US GMP regulations state that “Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: …..”. As a result of the increase in fraud and data falsification detected during inspections, the FDA has developed Compliance Program Guide 7346.832 for Pre-Approval Inspections which will be fully implemented in May 2012. One objective of this CPG is the data integrity audit directly impacting QC laboratories. In addition the European Union has just made a new law (2001/62/EU) regarding the security of global pharmaceutical supply chain which includes contract laboratories.
The course will be based on the life cycle of a laboratory record and look at the integrity and security of it throughout its life time. We will discuss paper records as well as hybrid systems and electronic records.
This 2 day course, a combination of lectures and linked workshops, has the following objectives:
1. To present the regulatory requirements and relevant critical regulatory observations concerning laboratory data integrity and security.
2. To provide attendees with the tools and techniques to define “complete data” in the context of paper, hybrid and electronic records to ensure the integrity and security of laboratory records regardless of the mode of generation.
3. To provide understanding of best practices in the life cycle of laboratory records