CHAPTER 11: Data Integrity and Paper Records: Blank Forms and Instrument Log Books Check Access

Document control is a fundamental tenant of GXP regulations. This is easily understood and can be implemented in paper and electronic forms relatively easily. However, a major problem is found at the back of many SOPs in analytical laboratories and this is a blank form. This has been thoughtfully designed by the subject matter expert who wrote the procedure to help people record the execution of the SOP. The problem is that blank forms can be filled in, then discarded if the analyst is not happy with the result, photocopied and filled in again and again. Blank forms are high on every regulator's hit list, as we will see in this chapter. Another paper document is a log book for analytical instruments and chromatographic columns that should be used to record the use and maintenance of each one. The logs need to be controlled but if used correctly can be a valuable resource in ensuring data integrity in the second person review presented in Chapter 17.