1. What Records are E-Records? A Process Control System Case Study Jeffrey Beck Manager, Quality Engineering Ortho-McNeil Pharmaceutical, Inc.

2. Objectives  Discuss recent experiences in applying Part 11 guidance to a SCADA/PLC lyophilizer control system, with recipe management functions.  Provide feedback on: –Scope –Definitions/criteria for identifying electronic records –Records required by predicate rules

3. Recipe Management Overview  Each recipe in the process control system is made up of several critical process parameters stored in a named file.  Recipes are first “approved” through quality system (change control and electronic document management) before being entered and saved in the process control system.  The control system loads the recipe parameters from its recipe management system, not from the document management system.  The recipe parameters are printed to a paper report after the cycle begins, and this report is signed by the operator.

4. Recipe Issues  Is the recipe in the process control system a required record at all? –Some considered it equivalent to “software”. –Some considered it a part of the Master Production Record.  Which record is being “relied on to perform regulated activities”? –Some thought approval of the recipe document was the only regulated activity, others believed loading process parameters into a control system was also regulated.

5. Resolutions and Criteria  The recipe in the process control system is managed as a discrete unit and is therefore a record (under 211.68 (b)), distinct from the control software.  Loading process parameters is a regulated activity. Both versions of the recipe (document management and process control system) are electronic records under Part 11.  Records “used to perform regulated activities” may also include stored, reusable inputs to process control and other automated systems.  In this case, the electronic recipes may be considered “low impact” as the likelihood of an undetected error is low.

6. Conclusions and Comments  The narrow scope for Part 11 defined in the current guidance is appropriate, and should be written into a revised regulation.  Within this narrow scope, the definition of electronic records required by predicate rules would benefit from more detail, supported by some specific examples.  The current definition should be refined to make clear that “use for regulated activities” may include electronic records used as inputs by computer systems.  There may also be a need to clarify which records are required in addition to those specifically identified in predicate rules.