What Records are E-Records?

A Process Control System Case Study

Jeffrey Beck
Manager, Quality Engineering
Ortho-McNeil Pharmaceutical, Inc.
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
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.
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.
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.
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.