What Records are E-Records?A Process Control System Case Study

Jeffrey BeckJeffrey Beck

Manager, Quality EngineeringManager, Quality Engineering

Ortho-McNeil Pharmaceutical, Inc.Ortho-McNeil Pharmaceutical, Inc.

Objectives

Discuss recent experiences in applying Part 11 guidance to a Discuss recent experiences in applying Part 11 guidance to a SCADA/PLC lyophilizer control system, with recipe SCADA/PLC lyophilizer control system, with recipe management functions.management functions.

Provide feedback on:Provide feedback on:

– ScopeScope

– Definitions/criteria for identifying electronic recordsDefinitions/criteria for identifying electronic records

– Records required by predicate rulesRecords required by predicate rules

Recipe Management Overview

Each recipe in the process control system is made up of several Each recipe in the process control system is made up of several critical process parameters stored in a named file.critical process parameters stored in a named file.

Recipes are first “approved” through quality system (change Recipes are first “approved” through quality system (change control and electronic document management) before being control and electronic document management) before being entered and saved in the process control system.entered and saved in the process control system.

The control system loads the recipe parameters from its recipe The control system loads the recipe parameters from its recipe management system, not from the document management management system, not from the document management system.system.

The recipe parameters are printed to a paper report after the The recipe parameters are printed to a paper report after the cycle begins, and this report is signed by the operator. cycle begins, and this report is signed by the operator.

Recipe Issues

Is the recipe in the process control system a required record at Is the recipe in the process control system a required record at all?all?

– Some considered it equivalent to “software”.Some considered it equivalent to “software”.

– Some considered it a part of the Master Production Record.Some considered it a part of the Master Production Record.

Which record is being “Which record is being “relied on to perform regulated relied on to perform regulated activities”activities”??

– Some thought approval of the recipe document was the only Some thought approval of the recipe document was the only regulated activity, others believed loading process parameters into regulated activity, others believed loading process parameters into a control system was also regulateda control system was also regulated. .

Resolutions and Criteria The recipe in the process control system is managed as a The recipe in the process control system is managed as a

discrete unit and is therefore a record (under 211.68 (b)), discrete unit and is therefore a record (under 211.68 (b)), distinct from the control software.distinct from the control software.

Loading process parameters is a regulated activity. Both Loading process parameters is a regulated activity. Both versions of the recipe (document management and process versions of the recipe (document management and process control system) are electronic records under Part 11.control system) are electronic records under Part 11.

Records “used to perform regulated activities” may also include Records “used to perform regulated activities” may also include stored, reusable inputs to process control and other automated stored, reusable inputs to process control and other automated systems.systems.

In this case, the electronic recipes may be considered “low In this case, the electronic recipes may be considered “low impact” as the likelihood of an undetected error is low.impact” as the likelihood of an undetected error is low.

Conclusions and Comments

The narrow scope for Part 11 defined in the current guidance is The narrow scope for Part 11 defined in the current guidance is appropriate, and should be written into a revised regulation.appropriate, and should be written into a revised regulation.

Within this narrow scope, the definition of electronic records Within this narrow scope, the definition of electronic records required by predicate rules would benefit from more detail, required by predicate rules would benefit from more detail, supported by some specific examples.supported by some specific examples.

The current definition should be refined to make clear that “use The current definition should be refined to make clear that “use for regulated activities” may include electronic records used as for regulated activities” may include electronic records used as inputs by computer systems.inputs by computer systems.

There may also be a need to clarify which records are required There may also be a need to clarify which records are required in addition to those specifically identified in predicate rules.in addition to those specifically identified in predicate rules.