CHAPTER 14: Data Integrity Centric Analytical Instrument Qualification and Computerised System Validation Check Access

Typically, computerised system validation and analytical instrument qualification have been separate tasks, however, with the publication of the updated version of United States Pharmacopoeia <1058> on AIQ, the two tasks are now integrated. From Level 1 of the data integrity model presented in Chapter 5, AIQ and CSV are essential tools for ensuring data integrity. It is essential that software applications are configured to ensure the protection of electronic records and tested to demonstrate that they work as intended. This requires a system architecture that protects records and a flexible approach to computerised system validation. This chapter is not the intended to be a detailed discussion of computerised system validation of laboratory systems as this can be found in other references. Instead, this chapter outlines a general approach for ensuring data integrity for laboratory systems when they undergo analytical instrument qualification with or without computerised system validation. As the new version of USP <1058> contains some major differences these are outlined in this chapter as they will have an impact on the way you now must approach AIQ.