Scribd
Upload
2K views2 pages

Risk Assessment Example For CSV - EDMS

This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

Uploaded by

venki_bee
Copyright
© Attribution Non-Commercial (BY-NC)
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
2K views2 pages

Risk Assessment Example For CSV - EDMS

This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

Uploaded by

venki_bee
Copyright
© Attribution Non-Commercial (BY-NC)
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
You are on page 1/ 2

WORKED EXAMPLE

Risk Assessment Form


Fixemol Facility EDMS

Example only - Not all-inclusive


Project Number

Project Title / Risk Assessment Overview

FXM-123

Assessment Scope / Assumptions Made See relevant CS Validation Plan. Function Subfunction Assessment of Risk Probability Severity Measures Class Detect. Priority

Relevance (GxP / Business)


GxP GxP GxP

Risk Scenarios

Document Approval

Display document to approve

Wrong document displayed Corrupted document Incorrect version displayed Approver not authorized, but accepted: system bug wrongly configured fraud Approver authorized, but not accepted bug configuration Operation seems successful but approval applied to incorrect document incorrect document incorrect version

M L M

H H H

One Three One

M H L

H L H

Specific testing. User SOP Acceptable Testing. User SOP

Apply electronic signature to approve

GxP

L M L

H H H

Three One Three

L L L

M H M

System test Config test. Config SOP including verification Training and security policy

GxP

L M

L L

Three Three

H H

L L

Acceptable Acceptable

GxP

L L

H H

Three Three

L L

M M

Design review of logic. System test Design review of logic. System test

Risk Assessment Approved by:

Page 1 of 2

WORKED EXAMPLE

Risk Assessment Form


Fixemol Facility EDMS

Example only - Not all-inclusive


Project Number

Project Title / Risk Assessment Overview

FXM-123

Assessment Scope / Assumptions Made See relevant CS Validation Plan.

Function

Subfunction

Relevance (GxP / Business)


GxP

Risk Scenarios

Assessment of Risk Probability Severity

Measures Class Detect. Priority

Apply electronic signature to approve

Incorrect approver details recorded Incorrect signature meaning recorded Time/date details incorrect Rejected document is flagged as approved

GxP GxP Reject document if approved GxP

Risk Assessment Approved by:

Page 2 of 2

You might also like