This document provides a framework for assessing whether a system has impact on Good Manufacturing Practices (GxP) processes and determining the appropriate validation approach. It involves evaluating 14 questions to identify if the system is considered GxP. If any question is answered yes, the system has a GxP impact. It also evaluates if the system stores or allows electronic signatures for electronic records required by regulators. Finally, it categorizes the software based on the GAMP 5 framework as an operating system, standard software package, configurable software package, or custom software. The assessment aims to establish the level of validation required.

1. 1. Introduction
A system GxP impact assessment needs to be carried out in order to ascertain its impact over
various GxP processes and subsequent validation efforts required. The assessment should be
carried out by the user department in consultation with IT team and system vendor.
For each question below evaluate whether the system has impact on GxP process or not. If any of
the questions is answered as “Yes”, then the system is considered as having GxP Impact and
Computerized System Validation will be required. The validation approach and deliverables can be
determined on the basis of this initial risk assessment.
2. GxP assessment
Select appropriate option from “Yes/No/NA” for each “GxP Assessment” section. If “Yes” is
selected needs to mention remark in “Remark” column.
ID Item Yes No NA REMARK
GxP-1
Does system automate or control any of:
Manufacturing, processing, packing, or
holding of in process material, Raw material
and drug product includes packaging and
labeling operations?
GxP-2
Is the system original source of data to
automate or control any of: Manufacturing,
processing, packing, or holding of an in
process material, Raw material and drug
product includes packaging and labeling
operations?
GxP-3
Is the system used for control/monitoring
?(e.g. Environmental monitoring, HVAC,
Purified H2O, Compressed air )
GxP-4
Does system generate analytical data for
testing of finished product, in process
material, raw material, stability, purifies water
and packing material sample?
GxP-5
Is system use for sample management of
finished product, in process material, raw
material, stability, purifies water and packing
material sample?

2. GxP-6
Is this system used for calculations or
algorithms that might affect product quality,
patient safety and Data integrity?
GxP-7
Is the system used to create, modify,
maintain, archive, retrieve, or transmit data
concerning product quality, patient safety
and data integrity?
GxP-8
Is the system used for GxP support functions
like calibration, maintenance and
qualification of equipment /instrument?
GxP-9
Is the system used to handle CAPA, change
control, incident, audit, lab event and recall?
GxP-10
Is the system used for handling market
complaints, or adverse event reporting? /
electronic document submission/reporting to
regulatory agencies?
GxP-11
Is the system used for quality trending,
quality matrices and or product review?
GxP-12
Is this system used to maintain records of
training of personnel?
GxP-13
Is the system used for product disposition?
(Release /Reject/Disposal)
GxP-14
Is the system used for employee
identification and access?
If ANSWER of any above Question is “Yes”, then system is “GxP” If all ANSWER of above
Question is “No”, then system is “Non GxP and further assessment is not required”

3. 3. Electronic records and electronic signatures applicability
Select appropriate option from “Yes/No” for each “ER-ESapplicability” section. If “Yes” is selected
needs to mention remark in “Remark” column.
ID ITEM YES NO REMARK
1.
Does system store electronic record which is required by
regulatory agency?
2.
Does the system include functionality that allows users to sign
records electronically which is required by regulatory agency?
If the ANSWER to QUESTIONS 1 is “Yes”, then ER is applicable to the system.
If the ANSWER to QUESTIONS 1 is “No”, then assessment of “QUESTION 2” is not required.
If the ANSWER to QUESTIONS 2 is “Yes”, then ER-ES is applicable to the system.
4. Classification of software category based on GAMP 5
4.1 Select appropriate option from “Yes/No” for each “Classification of software category”
section.
Sr. No. GAMP 5 categorization checklist YES NO
1 Is the system established commercially and is used to run other
programs/applications?
2 Does the system consist of software which is not directly useful for
business purposes but makes the computer hardware useful? An
example is the Windows Operating System?
3 Is the system used to perform basic tasks, such as recognizing input
from the keyboard, sending output to the display screen, keeping track
of files and directories on the disk, and controlling peripheral devices
such as disk drives and printers?
4 Is the system available as a ready-made product for sale to the general
public?
5 Can the system be implemented without performing any customization
or configuration to it (i.e. system will be used “As-Is”)?
6 Can the system be configured for use for a specific function without
altering the basic program? In other words, can the system be tailored to
meet your business requirements/needs?

4. 7 Does the system consist of a program or group of programs specially
designed for the end users?
4.2 Based on above mentioned GAMP 5 categorization checklist Application software falls
into one of the categories as:
GAMP 5
category
Checklist Evaluation
Category 1 Operating System
[Note: If the answer to question 1 to 3 is Yes, then category 1 is
applicable]
Category 3 Standard Software Packages (Commercial Off the Shelf (COTS) As-Is)
[Note: If the answer to question 4 and 5 is Yes, then category 3 is
applicable]
Category 4 Configurable Software Packages (Configurable COTS)
[Note: If the answer to question 4 and 6 is Yes, then category 4 is
applicable]
Category 5 Custom (Bespoke) Software
[Note: If the answer to question 7 is Yes, then category 5 is applicable.]