CHAPTER 7: Data Integrity Policies, Procedures and Training Check Access

Owing to either poor data management practices or data falsification in the industry, regulatory agency inspectors are now trained to detect the data integrity violations. The pharmaceutical industry needs to respond and not simply by paying lip service to the subject but by having effective data integrity policies and procedures in place throughout an organisation from an overall data integrity policy, good documentation practices for paper, hybrid and computerised systems but also how to interpret laboratory data. To do this, the key issue for laboratories working GMP or GLP is to understand the terms complete data and raw data, which is explained in detail here. Coupled with the policies and procedures there must be effective staff training and, where necessary, evidence of the effectiveness of that training. Typical poor documentation practices and record keeping failures are highlighted here as a means of ensuring that they are avoided. This chapter will only focus on training for data integrity and will not consider the wider scope of training in GXP regulations as applicable for staff to perform their jobs.