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Periodic Review Checklist 1

The document outlines a periodic review checklist for evaluating a system with over 15 questions covering risk assessment, supplier evaluation, incident handling, procedure and qualification changes, calibration activities, user access controls, and available upgrades. It includes sections for documenting the review period, results for each question, recommended next steps, and approval signatures.

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Srinivas Reddy Maram
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352 views2 pages

Periodic Review Checklist 1

The document outlines a periodic review checklist for evaluating a system with over 15 questions covering risk assessment, supplier evaluation, incident handling, procedure and qualification changes, calibration activities, user access controls, and available upgrades. It includes sections for documenting the review period, results for each question, recommended next steps, and approval signatures.

Uploaded by

Srinivas Reddy Maram
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PERIODIC REVIEW CHECKLIST

Note: The below tables do not contain the complete set of items to be evaluated as part of Periodic Review
process and serves as a guidance or example on how a Periodic Review Template could be created. Based on the
applicable local regulations, processes at your organization, system classification and intended usage tailor the
template as needed.

If you have more questions, please write to us at [email protected]

Periodic Review Start Date:

Periodic Review End Date:

S. No. Question Results Recommended Additional


Next Steps (if comments
applicable)
1 Is Risk Assessment and System  Yes
Classification performed up to  No
date?  N/A

2 Is the supplier Evaluation up to


date?
3 Are the changes performed on the
system follows the applicable
change process?
4 Are there any incidents, deviations,
Nonconformances happened since
the last review?
5 Are the incidents, deviations,
Nonconformances analyzed and
closed with proper justification?
6 Are there any changes to the
procedure (business operations as
well as system administration) for
the review system? Does this
impact the current package and
periodic review process?
7 Is the qualification performed on
the system follows the applicable
change control process and
remains in compliance?
8 Are the Calibration / PM activities
performed as per the schedule?
9 Is there an Instrument Logbook (s)
available and meets the
requirements set?
10 Is the audit trail review process
performed?
S. No. Question Results Recommended Additional
Next Steps (if comments
applicable)
11 Is the archiving of data happens as
described in the procedures?
12 Has user certification process
performed on the frequency
defined?
13 Is the data restricted folders and
network drives remain in the
restricted state for users?
14 Are there any procedural controls
establish as par to the Remediation
or Qualification or previous
Review? If yes, are these still valid?
15 Are there any new upgrades
available from the vendor that
could be leverage for better
compliance?

Summary of Documents Reviewed

Document Number Document Title

Overall Conclusion of Review

Periodic Review Report Approvals

Function Name Signature Date


Author
Business System Owner
Quality Assurance

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