Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 1 of 9
GxP ASSESSMENT DOCUMENT OF SCADA SYSTEM
FOR XYZ
Equipment ID : [ ]
Location : [ ]
Supersedes No. : [ ]
MFG Name : [ ]
Effective Date : [_________________]
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 2 of 9
CONTENTS
1.0.0 APPROVAL SIGNATURES:................................................................................................3
2.0.0 GENERAL:.......................................................................................................................... 4
2.1.0 PURPOSE:...................................................................................................................4
2.2.0 SCOPE:........................................................................................................................4
2.3.0 REVISION HISTORY:..................................................................................................4
3.0.0 RESPONSIBILTY:...............................................................................................................5
4.0.0 REFERENCES:.................................................................................................................... 5
5.0.0 GXP ASSESSMENT............................................................................................................6
6.0.0 LIST OF ABBREVIATIONS.................................................................................................9
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 3 of 9
1.1.0 APPROVAL SIGNATURES:
The signatures below indicate approval of this GxP Assessment.
GxP ASSESSMENT APPROVAL
Prepared By Name Signature & Date
Mystical Vision
Technologies
Indoco Remedies Ltd. Plant-III, Goa
Reviewed By Name Signature & Date
Engineering
Information
Technology (IT)
Production
Quality Assurance
Indoco Remedies Ltd. Plant-III, Goa
Approved By Name Signature & Date
Head- Quality
Assurance
Authorized By Name Signature & Date
Plant Head
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 4 of 9
2.1.0 GENERAL:
2.2.0 PURPOSE:
The purpose of this GxP Assessment is to identify and document that the SCADA system of “XYZ”
is determinate the GxP criteria.
2.3.0 SCOPE:
This GxP Assessment is applicable of SCADA system “XYZ” which is located in “ABC”.
2.4.0 REVISION HISTORY:
Version No. Effective Date Reason for Change
00 Initial Document
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 5 of 9
3.1.0 RESPONSIBILTY:
Mystical Vision Technologies:
Collect all manuals and documents or any other data necessary for the preparation, Review and
execution of GxP Assessment from M/S. Indoco Remedies Ltd. Plant-III, Goa.
Preparation, Review of GxP Assessment.
Indoco Remedies Ltd. Plant-III, Goa
4.1.0 Engineering To Review GxP Assessment
Information Technology
(IT) To Review GxP Assessment
Production To Review GxP Assessment
Quality Assurance To Review GxP Assessment
Head- Quality
Assurance To Approve GxP Assessment
Plant Head To Authorized GxP Assessment
REFERENCES:
The GxP Assessment Document is consistent with the following references:
Guideline Details
GAMP-5 Good Automated Manufacturing Practices
21 CFR Part 11 Part 11 Electronic Records; Electronic Signatures
EU GMP Annex-11 European Union Good Manufacturing Practices Annexure-11
VMP Validation Master Plan (MVT/IRL/VMP-001/00)
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 6 of 9
5.1.0 GXP ASSESSMENT
Response
Sr. No GxP Questionnaires
YES or NO
Does the application or system directly control, record for use or
01 monitor GxP manufacturing or packaging process and affect YES
directly or indirectly affect the product quality?
Does the application or system directly control, record for use or
02 NO
monitor laboratory testing, clinical or safety data?
Does the application or system perform GxP calculations or
03 algorithms that will support a regulatory submissions or NO
registrations?
Is the application or system an integral part of the
04 equipment/instrumentation/identification used in testing, release NO
and/or distribution of the product/sample?
Does the application or system define material to be used? i.e.
05 NO
raw material, packaging components, formulations, etc
Can the application or system be used for product/sample recall,
reconciliation, stock tracing, product history or product- related
06 NO
customer c
omplaints?
Does the application or system is used to support quality control
07 NO
product release?
Does the application or system handle data which could impact
08 YES
product purity, strength, efficiency, identity, status or location?
Does the application or system employ electronic signature
09 capabilities and/or provide the sole record of the signature on a NO
document subject to review by a regulatory agency?
Is the application or system used to maintain compliance with
10 YES
GxP requirements?
Does the application or system create, update or store data prior
11 NO
to transforming to an existing validated system?
Response
Sr. No GxP Questionnaires
YES or NO
12 Does the application or system used for physical access to GxP NO
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 7 of 9
to the environment (i.e. area or location)?
Does the application or system the official, auditable, archive or
13 YES
record of any regulated activity?
Is the application or system used for GxP data backup, restore,
14 NO
archival or storage?
Does the application or system use for GxP data security or
15 NO
access/ domain control?
Is the application or system used for collecting, monitoring,
16 signaling, assessing and evaluating adverse effects information NO
from healthcare provider and patients. i.e. pharmaconvigiliance?
Is the application or system used for data security or access
17 NO
control?
Does the application or system is used to support quality control
18 NO
product release?
Does the application or system control or store GxP documents
19 YES
data?
20 Does System use for employee identification and access? NO
21 Does System use for quality trending or product review? NO
Does the software component of the system analyze and
22 categories in GAMP-5 software category-1 (i.e. Infrastructure NO
Software)
Does the software component of the system analyze and
23 NO
categories in GAMP-5 software category-2 (i.e. No longer used)
Does the software component of the system analyze and
24 categories in GAMP-5 software category-3 (i.e. Non-Configured NO
Software)
Response
Sr. No GxP Questionnaires
YES or NO
Does the software component of the system analyze and
25 categories in GAMP-5 software category-4 (i.e. Configured YES
Software)
Does the software component of the system analyze and
26 categories in GAMP-5 software category-5 (i.e. Custom NO
Software)
27 Does the hardware component of the system analyze and YES
categories in GAMP-5 Hardware category-1 (i.e. standard
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 8 of 9
hardware component)
Does the hardware component of the system analyze and
28 categories in GAMP-5 hardware category-2 (i.e. custom built NO
hardware component)
GxP Determination: If “yes” is the response to any of the 28 GxP questions (above) then the system
is GxP Applicable.
01 Determination: Yes or No YES
Remark The system is GxP applicable
Vendor: Client:
Mystical Vision Technologies,
Vadodara Indoco Remedies Ltd. Plant-III, Goa
Title GxP Assessment of SCADA System for XYZ
Equipment ID Document No. Page 9 of 9
6.1.0 LIST OF ABBREVIATIONS
Acronym Description
cGMP Current Good Manufacturing Practices
GAMP Good Automated Manufacturing Practices
GMP Good Manufacturing Practices
ID Identification Number
GxP Good ‘x’ Practice, where ‘x’ one of clinical, laboratory, manufacturing etc
PLC Programmable Logic Controller
MVT Mystical Vision Technologies
IRL Indoco Remedies Ltd.
SCADA Supervisory Control And Data Acquisition
