Cfr Part 11 - Honeywell Experion PKS Specifications And Technical Data

EP03-300-200
Release 200

21 CFR Part 11

The Experion PKS system provides enhanced capabilities to support the regulated industry and their
unique requirements related to FDA regulations, particularly compliance with 21 CFR Part 11. The
Control Builder related features are discussed in this section. The Server-related features are
described in EP03-200-200, Experion PKS Server Specifications and Technical Data. For more detail
on validating an Experion PKS System, consult 'System validation with Experion PKS' White Paper.
The Control Builder supports three levels of version control:
Manual Version Control,
-
- Basic Version Control, and
- Qualification and Version Control System (QVCS).
These three options are discussed below. The last option, QVCS, specifically supports the regulated
industries and makes system validation easy and efficient.
Manual Version Control is the system default. It allows a user to enter version specific information in
a version parameter available on each configurable Control Builder object. The user is responsible for
updating and controlling the version information. Four additional parameters are maintained by the
system: date created, created by, date modified and modified by.
Basic Version Control is standard available and is enabled through the system preferences menu. It
differs from the functionality mentioned above by automatically assigning a version number and
incrementing it on-change. The version number increment is based on a minor or major change. The
system defines a major change as the addition of a FB or the creation of a parameter connection. A
minor change is, for example, a parameter change or a graphical change. In addition, the version
number is shown on the Control Builder tree view and in the chart title.
Qualification and Version Control System (QVCS) is a licensable option. QVCS is more than a
version control system because it simplifies system qualification by defining and enforcing a user
defined development lifecycle. The user also defines, as part of the lifecycle, what configuration may
be loaded to a controller. The enforced lifecycle guarantees an implementation procedure and reduces
the number of Standard Operating Procedures while eliminating manual signatures and paper trails.
For each configuration object, the system maintains an individual audit trail and stores each individual
version in a version repository. The user is able to retrieve specific versions into the project side of the
Control Builder. The QVCS also allows a specific version of an object to be compared with the checked
out version, the version currently on the monitoring side of Control Builder, the previous version or a
specific version selected in the QVCS. The difference report will indicate in detail, which changes,
additions and deletions have occurred between the two versions.
Experion PKS CEE-based Controller Specifications and Models
QVCS provides the user with the
ability to define the development
lifecycle and the electronic
signatures required to qualify a
configuration object. The system is
flexible and allows for single or
multiple electronic signatures.
Objects can only be modified once
they are checked out of the QVCS
system. Only the user who checked
the object out can modify the
object. The full user name is stored
in the QVCS log for each user
interaction with the system.
12
December, 2003
Version 1.0