Recent Observation for IT system controls

Mohamed Anvar Deen

CSV_Validation Manager at Accenture

发布日期: 2023年9月12日

?? Lack of Access Controls , ???? Unauthorized Admin Rights, ?? Traceability Gap, ?? Inadequate Backups, ?? Software Expertise Gap.

For more Details : https://www.dhirubhai.net/feed/update/urn:li:activity:7107376917523148800?utm_source=share&utm_medium=member_desktop

For More IT Observations : Join now for free and access all IT observations through Anvar's FDA 483 Tech Observation Alerts group.?(https://www.dhirubhai.net/groups/10393807/)

要查看或添加评论，请登录

Mohamed Anvar Deen的更多文章

"WHAT IF -Series#1"

2025年2月17日

"WHAT IF -Series#1"

Revolutionizing Regulatory Oversight: The Potential of AI-Driven Audits in the Pharmaceutical Industry The U.S.

1 条评论
"WHAT IF -Series#1"

2025年2月17日

"WHAT IF -Series#1"

Revolutionizing Regulatory Oversight: The Potential of AI-Driven Audits in the Pharmaceutical Industry The U.S.
FDA Exposes Record Deletion & Falsified Data in Pharma Plant: A Crisis of Trust and Compliance – Recent 483 observation for IT systems.

2025年2月13日

FDA Exposes Record Deletion & Falsified Data in Pharma Plant: A Crisis of Trust and Compliance – Recent 483 observation for IT systems.

In the pharmaceutical industry, compliance with Good Manufacturing Practices (GMP) is not just a regulatory requirement…
Recent observation on IT system controls

2022年12月23日

Recent observation on IT system controls

Is that companies are not serious about data integrity or users are not trained enough on Data integrity. Yes, recently…

1 条评论
Recent IT GxP 483 and It's CAPA "SUGGESTION"

2020年11月2日

Recent IT GxP 483 and It's CAPA "SUGGESTION"

Hope all the beloved members in the group are safe and healthy at this pandemic situation. Dear Reader's, SME's , GxP…

11 条评论
Recent observation for Computer control : Master BMR soft copy was controlled by production

2020年2月7日

Recent observation for Computer control : Master BMR soft copy was controlled by production
Recent observation on Computer controls

2020年2月3日

Recent observation on Computer controls

Administrative privileges assigned to analyst. Deletion of Test results and aborted sample set results .

3 条评论
Observation Related to Audit trail: Failed to review audit trail periodically

2019年10月14日

Observation Related to Audit trail: Failed to review audit trail periodically
Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

2019年10月12日

Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

1 条评论
Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

2019年10月12日

Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

6 条评论

See all articles

Mohamed Anvar Deen的更多文章

"WHAT IF -Series#1"

"WHAT IF -Series#1"

FDA Exposes Record Deletion & Falsified Data in Pharma Plant: A Crisis of Trust and Compliance – Recent 483 observation for IT systems.

Recent observation on IT system controls

Recent IT GxP 483 and It's CAPA "SUGGESTION"

Recent observation for Computer control : Master BMR soft copy was controlled by production

Recent observation on Computer controls

Observation Related to Audit trail: Failed to review audit trail periodically

Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

Observation for Failure to Restrict "Recycle bin & Desktop D Drive"

社区洞察