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. Discuss recent experiences in applying Part 11 guidance to a SCADA/PLC lyophilizer control system, with recipe management functions. Provide feedback on: 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. 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. 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 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. 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? 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? 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. 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. 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. 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. 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. 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. 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. 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. There may also be a need to clarify which records are required in addition to those specifically identified in predicate rules.