As regulatory
bodies require more ability to trace process changes and
ensure compliance with current Good Manufacturing
Practices (GMP), manufacturers are seeking ways to be
assured the process has not been altered without
approval.
MDT AutoSave is
part of the change management, approval and audit
infrastructure that ensures this compliance. It tracks
changes in PLCs, human-machine interface systems, and
workstations to ensure a proper audit trail and
notification of changes. This can be invaluable in
understanding what changes were made, why, and by whom.
In addition to providing rollback and recovery data in
the event of device failures, our software periodically
queries your automation devices and compares the code
running in the processor with the latest revision stored
on the AutoSave Server. If a
mismatch is detected (indicating someone went around our
system to make a change), a notification is sent to key
personnel highlighting the mismatch along with
information pinpointing the changes.
To further
increase the level of change control, AutoSave provides workflow approval routing and
electronic signature functionality in support of 21 CFR
11 guidelines.
MDT Software has enhanced AutoSave to support electronic
approval and audit trail management required by highly
regulated environments. Now, workflows and approvals can
be managed electronically, greatly streamlining the
review process. Features include:
•
Electronic signature
approvals
•
Multiple review
statuses
•
Verification and
confirmation processes
•
Additional security
features: password control, electronic log
messages,
configurable approval messages and more.
This feature set can be enabled on devices requiring
a formal change process, allowing user-defined groups
for review and approval. As a change progresses through
the review process its status is updated to indicate who
has reviewed the change. Only approved changes can be
downloaded for testing, and only after validation can it
be “implemented.” All activities are logged, and reports
can be generated on-demand to show activity and status
of changes
MDT serves the
life sciences market through our distribution and
integration network.
