PHARMADEVILS

IT DEPARTMENT

[Appendix 2e-Template of GxP Assessment]

Title: GxP Assessment for <System Name> Page

Document No. <Document No.> 1 of 10

GxP Assessment
for
<System Name>
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[Appendix 2e-Template of GxP Assessment]

APPROVAL PAGE

Prepared By:

Name Designation Department Signature Date

Reviewed By:

Name Designation Department Signature Date

Approved By:

Name Designation Department Signature Date

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[Appendix 2e-Template of GxP Assessment]

TABLE OF CONTENTS

1.0 INTRODUCTION ................................................................................................................................................... 4

2.0 PURPOSE ................................................................................................................................................................. 4
3.0 SCOPE ...................................................................................................................................................................... 4
4.0 RESPONSIBILITIES .............................................................................................................................................. 4
5.0 REFERENCES......................................................................................................................................................... 4
6.0 DOCUMENTATION PROCEDURE..................................................................................................................... 4
7.0 GxP ASSESSMENT CHECKLIST ........................................................................................................................ 4
8.0 OVERALL ASSESSMENT CONCLUSION ........................................................................................................ 9

REVISION HISTORY

Revision No. Effective Date Reason for Revision

Initial Document
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[Appendix 2e-Template of GxP Assessment]

1.0 INTRODUCTION:

2.0 PURPOSE:

3.0 SCOPE:

4.0 RESPONSIBILITIES:

5.0 REFERENCES:

6.0 DOCUMENT PROCEDURES:

7.0 GxP ASSESSMENT CHECKLIST:

This document consists of check list for below listed items:
1. GENERAL INFORMATION
2. GxP ASSESSMENT
3. ELECTRONIC RECORDS APPLICABILITY
4. ELECTRONIC SIGNATURE APPLICABILITY
5. SYSTEM NATURE (OPEN/CLOSE)
6. COMPUTERIZED SYSTEM (SOFTWARE) CATEGORIZATION AS PER GAMP5
7. HARDWARE CATEGORY

(Tick mark “✓” whichever/ wherever is applicable in this document).

SECTION-A: GENERAL INFORMATION

QUESTION RESPONSE

INSTRUMENT
1. Does the system have an instrument? (Respond as
Yes
Yes/No)
Answer 2 and 3 if 1 is Yes, otherwise mark as NA
Instrument/Equipment Manufacturer:
Instrument/Equipment Model No.:
2. Instrument Manufacturer Name and Model No.

3. Brief description of the Instrument/Equipment

APPLICATION/SOFTWARE
4. Does the System have an Application/ Software?
(Respond as Yes/No)
Answer 5 and 6 if 4 is Yes, otherwise mark as NA
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[Appendix 2e-Template of GxP Assessment]

QUESTION RESPONSE
5. Application/ Software Name and Application/ Software Name:
Software Version No. Software Version:
6. Brief description of the Application/ Software
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[Appendix 2e-Template of GxP Assessment]

SECTION-B: GxP ASSESSMENT

Q. No. Questions (for GXP ASSESSMENT) (√) The Answers

Yes No
Q1 Does the Computerized system impact the patient safety?
N/A
Does the Computerized system functionality create any hazards to the environment Yes No
Q2
including people working on the system such as process control systems? N/A
Is the system involved in capturing information that would alert the organization to
Yes No
Q3 take an action or support the execution of an action that impacts the product quality
N/A
(e.g. product recall, adverse event reporting)?
Yes No
Q4 Does the system impact or store or retrieve data about the quality of the product?
N/A
Does the system produce data which is used to accept or reject product? (e.g.
Electronic Record System or critical process chart recorder) Yes No
Q5
Note: This data could be supporting data and need not be the only criteria for N/A
accepting or rejecting a product?
Is the system a process control system (e.g. PLC, HMI) that may affect product
Yes No
Q6 quality and is there any independent verification of the control system performance in
N/A
place?
Is the computerized application/system the official auditable, archive or record of any Yes No
Q7
regulated activity? N/A
Is the computerized system used to control and/or generate data and documentation to
Yes No
Q8 be included in a regulatory submission or otherwise submitted to the FDA, EMEA or
N/A
other similar regulatory agencies?
Yes No
Q9 Is the computerized system used as part of the company's Quality System?
N/A
Yes No
Q10 Is the computerized system used to control Quality System documentation?
N/A
Yes No
Q11 Is the computerized system used to control Manufacturing documentation?
N/A
Is the computerized system used to control Verification and Validation Yes No
Q12
documentation or data? N/A
Yes No
Q13 Is the computerized system used to control any packaging or labeling activities?
N/A
Is computerized system used to track/perform maintenance and/or calibration of Yes No
Q14
testing, laboratory, manufacturing or production equipment? N/A
Is the computerized system used to maintain purchasing, inventory, or distribution Yes No
Q15
data for the company's products? N/A

Note: If answer is “Yes” to any one question, then system shall be categorized as “GxP Applicable System” ; else
shall be categorized as “GxP Not Applicable System”
Conclusion of Section-B :The system is: GxP Applicable System GxP Not Applicable System

Note: If the system is categorized as “GxP Applicable System”, then answer the questions of Section-C.
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[Appendix 2e-Template of GxP Assessment]

SECTION-C: ELECTRONIC RECORDS APPLICABILITY

Q. (√) The
Questions (for Electronic Records Applicability)
No. Answers
Yes No
Q1 Does the system generate GxP applicable electronic records?
N/A
Yes No
Q2 Does the GxP applicable electronic records stored on durable media?
N/A
Note: If Answer to both the questions of Section-C are Yes, then Electronic Records is “Applicable” else “Not
Applicable”

Conclusion of Section-C :Electronic Recordsis: Applicable Not Applicable

SECTION-D: ELECTRONIC SIGNATURE APPLICABILITY

Q. (√) The
Questions (for Electronic Signature Applicability)
No. Answers
Yes No
Q1 Does the system has provision to practice Electronic Signature in system?
N/A
Yes No
Q2 Does the mechanism of Electronic Signature is enabled in the system?
N/A
Note: If Answer to both the questions of Section-D are Yes, then Electronic Signature is “Applicable” else “Not
Applicable”
Conclusion of Section-D :Electronic Signatureis: Applicable Not Applicable

SECTION-E: SYSTEM NATURE (OPEN/ CLOSE)

Close System: An environment in which system access is controlled by persons who are responsible for the
content of electronic records that are on the system
Open System: An environment in which system access is not controlled by persons who are responsible for the
content of electronic records that are on the system

Q.
Questions (for System Nature) (√) The Answers
No.
Yes No
Q1 Does the system is Close System?
N/A
Yes No
Q2 Does the system is Open System?
N/A
Conclusion of Section-E :System is: Close System Open System
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[Appendix 2e-Template of GxP Assessment]

SECTION-F: COMPUTERIZED SYSTEM (SOFTWARE) CATEGORIZATION AS PER GAMP5

(√) The
Q. No. Questions (for Software Categorization)
Answers
Are the software functions as operating software used to manage the operating
Yes No
Q1 environment of the computerized system?
N/A
Example: Operating system, Data base etc.

Are the software functions as utility software used to manage the utility function of the
Yes No
Q2 computerized system?
N/A
Example: Anti-virus, Remote access, Printer, Backup solution etc.,
Is the computerized system having software, only it is used to perform basic tasks,
such as recognizing input from the keyboard, sending output to the display screen, Yes No
Q3
keeping track of files and directories on the disk, and controlling peripheral devices N/A
such as disk drives, printers, office tools?

Is the computerized system application software, cannot be configured to suit the

Yes No
Q4 business process but runtime parameters can be entered / stored?
N/A
Example: Setting of the defined recipe, creation of users etc.

Is the computerized system application software, often very complex that can be
configured by the user to meet the specific needs of the user’s business process, but not Yes No
Q5
possible to alter the source code? N/A
Example: LIMS, Data Acquisition, SCADA systems, SAP etc.

Is the computerized system application software custom designed and coded to suit the Yes No
Q6
business process? N/A

Note: GAMP 5 categorization of Software with computerized system shall be considered as below:
1: If answer is Yes to anyone of the question among Q1 to Q3, but answer is No or N/A to all other Questions, then
Category 1 (Infrastructure Software).

2: If answer is Yes to only question, Q4, but answer is No or N/A to all other questions, then Category 3 (Non
configured Products).
3: If answer is Yes to only question, Q5, but answer is No or N/Ato all other questions, then Category 4
(Configured Products).
4: If answer is Yes to only question, Q6, then Category 5 (Custom Applications).

Conclusion of Section-F

The Software system is categorized as: Category 1 Category 3 Category 4 Category 5

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[Appendix 2e-Template of GxP Assessment]

SECTION-G: Hardware Category

Category 1: Standard Hardware Component
Standard hardware components should be documented including manufacturer or supplier details and version
numbers. IQ should verify installation and connection of components. The model, version number and where
available, serial number of pre-assembled hardware should be recorded.

Category 2: Custom built (Bespoke) Hardware Components

In addition to hardware category 1 requirements, bespoke items of hardware should have a design specification
and be subjected to acceptance testing. A supplier audit should be performed for bespoke hardware development.
Assembled systems using bespoke hardware from different sources require verification confirming compatibility
of interconnected hardware components. Any hardware configuration should be identified in the design
documentation and verified in the IQ.

Conclusion of Section-G:
System is: Category 1: Standard Hardware Component
Category 2: Custom built (Bespoke) Hardware Components :
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[Appendix 2e-Template of GxP Assessment]

8.0 OVERALL ASSESSMENT CONCLUSION:

The above Impact Assessment carried out for system in scope and conclusions are as below:
Section Title Outcome
GxP Applicable System
B GXP ASSESSMENT
GxP Not Applicable System

C ELECTRONIC RECORDS APPLICABILITY Applicable Not Applicable

D ELECTRONIC SIGNATURE APPLICABILITY Applicable Not Applicable

Close System
E SYSTEM NATURE (OPEN / CLOSE)
Open System
COMPUTERIZED SYSTEM (SOFTWARE) Category 1 Category 3
F
CATEGORIZATION AS PER GAMP5 Category 4 Category 5

G HARDWARE CATEGORIZATION Category 1 Category 2