IT - QC

Description of Responsibilities

1 Logbook Verification and Review of PTR
Verify IT-related logbooks, including Server Room
Temperature, Server Room Entry/Exit, Access Card Issue and
Return, Backup, Eurotherm FTP, Patch Update, and Access
Rights records.

2 Identification of Gaps and CAPA
Identify and document discrepancies, gaps, and non-
compliances during logbook verification. Initiate appropriate
corrective and preventive actions (CAPA), communicate
findings to concerned personnel, and follow up for timely
closure.

3 Site-Specific PTR Review
Review individual PTRs for sites to ensure completeness,
accuracy, and compliance with established procedures.
Communicate observations and coordinate necessary
corrective and preventive actions.

4 SOP Implementation and Compliance

5 SOP Review and Revision
Inform relevant departments about newly applicable SOPs and
coordinate follow-up to ensure implementation and
compliance.
Periodically review IT SOPs to identify the need for updates,
amendments, or revisions. Coordinate with concerned
departments for review, comments, and feedback.

6 Change Control Management
Initiate and coordinate change control procedures for changes
related to IT hardware, software, and SOPs, as applicable.
Ensure appropriate documentation and follow-up in
accordance with approved procedures.

7 Deviation and CAPA Management

8 SOP Finalization and Circulation
Initiate deviation documentation for deviations from approved
procedures, coordinate necessary corrective and preventive
actions, and follow up for timely closure.
Incorporate comments received from relevant departments,
finalize SOP documents for approval, and coordinate printing
and controlled circulation of approved SOPs.

9 Documentation Tracking
Maintain and update the Deviation Tracking Sheet and Quality
Risk Management (QRM) Sheet to ensure proper tracking and
documentation.

10 Verification of IT Forms and Records
Verify IT-related forms and records, including User Details,
Cronos, Ovis, Digital Clock Performance, Eurotherm, Folder
Creation/Modification, Group Details, and Server Hardening
records.

11 Forms and Formats Management
Ensure completeness and accuracy of IT forms and records.
Identify documentation gaps and coordinate appropriate
corrective actions. Review and update IT SOP templates and
formats, as required.

12 Training and Awareness
Conduct SOP training for new joiners and relevant personnel,
as applicable, to ensure awareness and understanding of
approved procedures. Maintain training records wherever
applicable.

13 Archival and Record Management
Ensure proper archival, maintenance, and retrieval of IT
logbooks, forms, formats, PTRs, and associated records in
accordance with approved document-control and record-
retention procedures.