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CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
Approval Page
Name
Designation
Department
Prepared By
Reviewed By
Approved By
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
Table of Contents
Purpose.......................................................................................................................................................4
Scope..........................................................................................................................................................4
References..................................................................................................................................................4
System Overview.......................................................................................................................................4
GxP Relevance...........................................................................................................................................5
References..................................................................................................................................................6
Level of Risk..............................................................................................................................................7
GAMP Categorization................................................................................................................................8
Summary....................................................................................................................................................9
Comments:.................................................................................................................................................9
Revision History........................................................................................................................................9
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
Purpose
This document is prepared to assess the GxP impact, GAMP categorization and risk level of the
system.
Scope
This document is applicable to XXXX system installed at XXXX location in USV Ltd.
References
a.
b.
System Overview
(Write system description, current procedure which shall be replaced by system, whether
application is customized or standard software, use of the system, process flow, etc..)
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
GxP Relevance
Questions
Yes/ No
5.1
5.2
Is the system used in the collection, analysis or storage of data from perclinical studies or clinical trials?
5.3
Is the system used to produce or process data that will be used in (drug)
regulatory submissions?
5.4
5.5
5.6
5.7
5.8
5.9
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
ERES
Applicable if the system is classified as GxP Relevant
Question
6.1
Yes/ No/
NA
Does the system support business processes that are part of the product
development, registration, manufacturing or the distribution of products
that are to be delivered to the US and/or European market and/or to any
other market that is regulated regarding ERES?
Yes/ No/
NA
6.2
6.3
6.4
If 6.2 and/or 6.3 is answered with Yes, Electronic records are applied to the system.
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
Level of Risk
For GxP relevant system, determine the Level of Risk (Severity of harm) based on system
impact on GxP relevance, Business relevance and failure consequence. Use below table for this
purpose.
Assessment Step:
Assessment regarding GxP relevance (Yes/No)
Assessment regarding Business relevance (Yes/No)
Assessment regarding Failure Consequence (High/ Moderate/ Low/ No)
If system is classified as GxP relevance, system must be automatically classified as business
relevance and at least moderate for the failure consequence.
If system is impacting on business, which means on activities like quality control, production,
sales, etc. then system should be classified as Business Relevance.
If system is classified as neither GxP nor business relevant, the classification of the failure
consequence could not exceed low.
If failure of system functionality causes a violation of GxP regulation, with direct impact on,
Product quality, Patient Safety and Data Integrity, then the system failure consequences shall
be High.
If failure of system functionality causes violation of GxP regulation, with No direct impact on,
Product quality, Patient Safety and Data Integrity, then the system failure consequences shall
be Moderate.
If failure of system functionality causes an indirect violation of GxP regulation, with No direct
impact on, Product quality, Patient Safety and Data Integrity then system failure consequences
shall be Low.
If failure of system functionality causes no impact on GxP regulation with no direct/ indirect
impact on, Product quality, Patient Safety and Data Integrity then system failure consequences
shall be No.
Yes- 10, No- 00, High- 20, Moderate- 08, Low- 02
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
GxP Relevance
Business
Relevance
Failure
Consequence
Caluculated
Risk
Yes
Yes
High
40
No
Yes
High
30
Yes
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
Moderate
Moderate
Low
No
Low
No
28
18
12
10
02
00
Level of Risk
High
Moderate
Low
Question
Response
7.1
7.2
7.3
7.4
Calculated Risk
7.5
Level of Risk
GAMP Categorization
Category
Question
Yes/ No/
NA
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
Summary
Respond to the questions according to section 5 to 8 of this document.
Questions
Response
10
Comments:
11
Revision History
CONFIDENTIAL-USV
USV LIMITED
High Level Risk Assessment (HLRA) for XXX system
CONFIDENTIAL-USV