CHAPTER 18: Record Retention Check Access

Retention of records generated during regulated GXP laboratory activities, e.g. method validation, analysis of non-clinical studies, clinical studies, analysis of starting materials, in process and finished goods and well as stability testing is an important requirement under existing GXP rules (most of which were written when paper was the dominant record format). Retention of paper records is well known and understood. However, electronic records generated by a computerised system will usually outlive the system that generated them. Records retention is the biggest problem facing any electronic or hybrid system as the records are stored in a proprietary format.