Are You Ready to Automate Processing Computer System Valida

Computer System Validation Template

PURPOSE

In this guide, we go over how to generate Computer System Validation (CSV) deliverables using linke
matrix, having unique IDs of each and every requirement.

This set of linked spreadsheets will help you stay in charge of all tasks related to the computer system
(including URS, RA, and FS) as you are required to per ISPE GAMP5. The idea here is to make it eas
deliverables in different spreadsheets by using formulas that automatically update content across all r
guaranteeing error-free mapping of User Requirements with Functional Specification, Configuration S
and Test Scripts to automatically develop a Traceability Matrix without wasting hours on verifying and

Most so-called computerized systems in regulated industries must not only be tailored to their intende
specific regulatory requirements. ISPE GAMP5 guidelines aim to safeguard patient safety, product qu
GxP computerized systems by facilitating and encouraging effective, reliable, and high-quality system
Assurance (often abbreviated to just CSA) is achieved by following computer system validation princip

GAMP advocates for a computerized system validation framework to achieve and maintain GxP comp
computerized system life cycle. The framework is based on system-specific validation plans and repo
appropriate operational controls. Validation plans and reports provide a disciplined and consistent app
requirements, leading to appropriate documentation at the right level. Such documents are valuable in
and passing regulatory inspections. The framework is applicable to the majority of computerized syste
built based on these principles by clarifying the scalability of the approach, and the central role of QRM
efficiently cover the broad range of systems in scope.

HOW TO USE THIS SPREADSHEET

The Basics

1. Columns with titles are shown in two formats: highlighted (yellow) and standard (purple).
2. Highlighted (yellow) columns are meant to be filled in or selected manually (e.g., by using the dropd
not change standard (purple) columns; they are updated automatically when a user enters data in the
3. Make sure to review all highlighted (yellow) fields before moving on to the next sheet.
4. The values in the highlighted (yellow) dropdown columns can be modified based on the requiremen
5. Do not change the formulas found in any sheet. This will change or stop the automated functions in

Understanding the URS Sheet

There are three columns:

1. URS ID column: Generated automatically only when information is added in the ‘User Requirement

2. Category column: Selected manually to define the category of a requirement (either functional or re

3. User Requirement Description column: Entered manually to define the requirement description.

Understanding the RA Sheet

There are four columns:

1. URS ID column: URS ID values are automatically populated from the ‘URS ID’ column of ‘URS’ and
dropdown.

2. RA ID Column: Generated automatically only when the URS ID is selected from the dropdown list o

3. Assessment of Risk Heading: Columns under this heading are:

• Relevance column: The relevance can be selected using a dropdown as either functional or regulat
• Risk Scenarios column: Risks related to the selected user requirement are documented in this colum
• Probability column: Probability can be selected from the dropdown as ‘H’ for high, ‘M’ for medium, o
Values in this dropdown are filled based on information provided in the RA Matrix.
• Severity column: Severity can be selected from the dropdown as ‘H’ for high, ‘M’ for medium, or ‘L’
this dropdown are filled based on information provided in the RA Matrix.
• Risk Class column: Automatically generated after selecting values in the Probability and Severity co
• Detectability column: Detectability can be selected from the dropdown as ‘H’ for high, ‘M’ for medium
Values in this dropdown are filled based on information provided in the RA Matrix.
• Risk Priority column: Automatically generated based on the selection of detectability only when valu
severity, and risk class columns are filled in. Values in this dropdown are based on information provid

4. Assessment of Risk After Mitigation column: Columns under this heading are:

• Risk Mitigation Action column: Risk mitigation actions for the identified risk scenario are documente
• Probability After Mitigation column: Probability after mitigation can be selected from the dropdown a
medium, or ‘L’ for low probability. Values in this dropdown are filled based on information provided in t
• Severity After Mitigation column: Severity after mitigation can be selected from the dropdown as ‘H’
‘L’ for low severity. Values in this dropdown are filled based on information provided in the RA Matrix.
• Risk Class After Mitigation column: Automatically generated after selecting values in the Probability
Severity after mitigation columns.
• Detectability After Mitigation Column: Detectability after mitigation can be selected from the dropdow
medium, or ‘L’ for low detectability. Values in this dropdown are filled based on information provided in
• Risk Priority After Mitigation column: Automatically generated on the selection of detectability after m
in the probability after mitigation, severity after mitigation, and risk class after mitigation columns are f
dropdown are filled based on information provided in the RA Matrix.
Understanding the FS Sheet

There are four columns:

1. URS ID column: The URS ID values are automatically populated from the ‘URS ID’ column of ‘URS
dropdown.

2. FS ID Column: Generated automatically only when the URS ID is selected from the dropdown list in

3. Functional Requirement Description column: Functional requirements related to the selected user r
and added manually in this column.

4. JIRA/Reference Task Number column: The JIRA/Reference Task Number for the specific URS/FS
entered manually in this column.

Understanding the CS Sheet

There are three columns:

1. URS ID column: The URS ID values are automatically populated from the ‘URS ID’ column of the ‘U
from the dropdown.

2. CS ID column: Generated automatically only when the URS ID is selected from the dropdown list o

3. Configurational Requirement Description column: Configurational requirements related to the selec

to be added manually in this column.

Understanding the PQT Sheet

There are eight columns:

1. RA ID column: The RA ID values are automatically populated from the RA ID column and selected

2. URS ID column: Generated automatically only when the RA ID is selected from the dropdown list o

3. PQT ID column: Generated automatically only when the RA ID is selected from the dropdown list o

4. Script ID column: The Script ID values are automatically populated from the Script ID column and s

5. Procedure Step column: Testing procedure requirements related to testing of the URS need to be d
column.

6. Expected Result column: The expected outcome/result of the test procedure step for the selected U
manually in this column.

7. Actual Result column: The actual result obtained after testing for the selected URS need to be docu
column.

8. Pass/Fail column: The status of the execution of test as (pass or fail) for the selected URS need to
this column.

Understanding the TM Sheet

You must fill in the sheets URS, RA, FS, CS, and PQT before this sheet can pre-populate automatica
this sheet:

1. URS ID column: Contains the URS IDs for the user requirement specifications.

2. RA ID column: Contains the RA IDs for the respective user requirement specifications.

3. RA Risk Class column: Contains the risk class as assessed in the RA sheet (not the RA matrix) for

4. FS ID column: Contains the FS IDs for the respective user requirement specifications.

5. CS ID column: Contains the CS IDs for the respective user requirement specifications.

6. PQT ID column: Contains the PQT IDs for the respective user requirement specifications.

Understanding the RA Matrix

This is important for risks identification and mitigation that come with various URS items. This sheet is
on a GAMP5 risk analysis. The tabulated risk calculation is designed and linked with other sheets (RA
to auto-generate the data.

Each URS item is analyzed to identify potential risks that specific functionality may pose from a functio
requirement perspective. Once identified, these risks are classified according to their severity and pro
mitigation is used to define risk priority. The following diagrams illustrate how this process is applied:

1. As shown above, risk class is initially defined for identified risk scenario(s) of each URS ID. For exa
carries a medium probability and a medium severity, this matches the tabs of both elements and yield
class 2).

2. Next, the risk class is compared with detectability. In our example from above (risk class 2), if detec
low, then the red-colored box depicts a high-risk priority for the identified risk scenario and requires co
high and medium risk priorities, mitigation is required. For low risk priorities, no action is required.

3. Based on the mitigation plan, risk priority is recalculated, recommended actions are updated, and th
uter System Validation (CSV)?

V) deliverables using linked sheets with a traceability

ed to the computer system validation deliverables

dea here is to make it easy to write validation
pdate content across all related sheets while
cification, Configuration Specification, Risk Scenarios,
ng hours on verifying and mapping data.

be tailored to their intended use but must also meet

patient safety, product quality, and data integrity in
e, and high-quality systems. Computer System
r system validation principles defined in the GAMP5.

e and maintain GxP compliance throughout the

validation plans and reports and the application of
plined and consistent approach to meeting regulatory
documents are valuable in successfully preparing for
rity of computerized systems. This guide has been
nd the central role of QRM, to effectively and

ndard (purple).
y (e.g., by using the dropdown function). Please do
a user enters data in the highlighted columns.
next sheet.
based on the requirements.
he automated functions in these linked sheets.
 in the ‘User Requirement Description’ column.

ent (either functional or regulatory).

quirement description.

S ID’ column of ‘URS’ and selected from the

d from the dropdown list of the ‘URS ID’ column.

ither functional or regulatory.

e documented in this column.
or high, ‘M’ for medium, or ‘L’ for low probability.
Matrix.
gh, ‘M’ for medium, or ‘L’ for low severity. Values in

Probability and Severity columns.

H’ for high, ‘M’ for medium, or ‘L’ for low detectability.
Matrix.
etectability only when values in the probability,
sed on information provided in the RA Matrix.

are:

scenario are documented in this section.

cted from the dropdown as ‘H’ for high, ‘M’ for
n information provided in the RA Matrix.
from the dropdown as ‘H’ for high, ‘M’ for medium, or
rovided in the RA Matrix.
g values in the Probability after mitigation and

selected from the dropdown as ‘H’ for high, ‘M’ for

on information provided in the RA Matrix.
tion of detectability after mitigation only when values
r mitigation columns are filled. Values in this
 ‘URS ID’ column of ‘URS’ and selected from the

d from the dropdown list in the ‘URS ID’ column.

ated to the selected user requirement are documented

r for the specific URS/FS requirement need to be

‘URS ID’ column of the ‘URS’ sheet and selected

d from the dropdown list of the URS ID column.

ments related to the selected user requirement need

A ID column and selected from the dropdown.

d from the dropdown list of the ‘RA ID’ column.

d from the dropdown list of the ‘RA ID’ column.

he Script ID column and selected from the dropdown.

g of the URS need to be documented manually in this

ure step for the selected URS need to be documented

cted URS need to be documented manually in this

he selected URS need to be documented manually in

pre-populate automatically. There are six columns in

tions.

pecifications.

et (not the RA matrix) for the respective URS.

pecifications.

pecifications.

nt specifications.
 URS items. This sheet is used to assess risk based
ked with other sheets (RA and PQT), using formulas

y may pose from a functional or regulatory

g to their severity and probability, after which risk
w this process is applied:

) of each URS ID. For example, if one identified risk

f both elements and yields a yellow colored box (risk

bove (risk class 2), if detectability is considered to be

k scenario and requires compulsory mitigation. For
no action is required.

ctions are updated, and the RA matrix is refreshed.

 URS ID Category
URS-0002 Functional
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 User Requirement Description
Login
 ASSESSMENT OF RISK

URS ID RA ID Relevance

URS-0001 RA-0002 Regulatory

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 ASSESSMENT OF RISK

Risk
Risk Scenarios Probability Severity
Class

Login H H 1
 ASSESSMENT OF RISK AFTER MITIGATION

Probability Severity
Risk
Detectability Risk Mitigating Action after after
Priority
mitigation mitigation
H L Login H H
TER MITIGATION

Risk Class Detectability Risk Priority

after after after
mitigation mitigation mitigation
1M M
 URS ID FS ID

URS-0001 FS-0002
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 Functional Requirement Description

Login
JIRA/ReferenceTask
Number
 URS ID CS ID
URS-0001 CS-0002
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 Configurational Requirement Description

Login
 Script
RA ID URS ID PQT ID Procedure Step
ID
RA-0001 URS-0001 PQT-0002 1 Login
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 Actual
Expected Result Pass/Fail
Result
 RA Risk
URS ID RA ID FS ID CS ID
Class

URS-0002 RA-0001 1 FS-0001 CS-0001

0
0
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0
0
0
0
0
0
 PQT ID

PQT-0001
DO NOT EDIT OR REMOVE! Probability
L M H
H 2 1 1
Severity

M 3 2 1

L 3 3 2

Get Risk Class

Detectability
H M L
1 M H H
Risk Class

2 L M H

3 L L M

Get High Risk Class