Comprehensive review of instruments & equipment’s to access the impact based on deviation

Page 1|8
 Comprehensive review of instruments & equipment’s to access the impact based on deviation

1.0 OBJECTIVE

The objective of this document is to assess the impact based on Change Control CC/IT/19-
002 for the equipments / instruments that needs data to be backed up on periodical basis.

2.0 SCOPE:

This comprehensive review is based on to identify the probable impact on the GMP system
due to this change control Reference Number: CC/IT/19-002

3.0 BACKGROUND:
As facility is under project stage & qualification - Initially QC & Microbiology Labs are made
qualified. To support the Lab systems, temporarily servers with Eq ID: CPGB/IT/SER-01 was
installed and qualified. Facility was designed with Central IT at packing block first floor for
full-pledged back up process. In order to have all the servers in the same location of the data
center, and to complete the cable dressing, network downtime was taken from 10:30 to 19:00
hours on 17/08/19. During this period, no connectivity was available. No QC systems will be
able to access the application. Since the cable dressing need to be performed post shift of
server, the network was down.

4.0 IDENTIFICATION OF REVIEW AND IMPACT ASSESSMENT TEAM:

The below mentioned personnel were identified as Subject Matter experts team, who will be
involved in the preparation/practical implementation of this Quality Risk Management.

Page 2|8
 Comprehensive review of instruments & equipment’s to access the impact based on deviation

SME’s Signature Log:

S.No Name Department Sign & Date

1 Vishnuvardhan V MB

2 Vijaykumar KR QC

3 Nalini K QA

4 Rajesh N QA

5 Shivabala B EN

6 Penmetsa Vamsi PRI

7 Arun Patel PRT & PPK

8 K. Veerendra IT

9 Vishwajith V QA

Page 3|8
 Comprehensive review of instruments & equipment’s to access the impact based on deviation

5.0 IMPACT ASSESSMENT:

IMPACT EVALUATION Laboratory system:
Qualification Back up Data
Equipment / Actual
date (Server/Stand availability
S. Dept. Instrument / Autoback Potential
alone) (Server/ Remarks
No Identification code up taken Impact
standalone on
D W M Y status)
CPGB/QC/HPL/01 10/07/18 √ √ √ √ Server 27/05/19 No impact
CPGB/QC/HPL/02 10/07/18 √ √ √ √ Server 27/05/19 No impact
CPGB/QC/HPL/03 28/08/18 √ √ √ √ Server 27/05/19 No impact
During the server downtime, the
CPGB/QC/HPL/04 28/08/18 √ √ √ √ Server 27/05/19 No impact Empower software runs from the
CPGB/QC/HPL/05 28/08/18 √ √ √ √ Server 27/05/19 No impact server. Hence due to server
downtime, Empower cannot be
CPGB/QC/HPL/06 28/08/18 √ √ √ √ Server 27/05/19 No impact access and no analysis can be
Quality CPGB/QC/HPL/07 02/02/19 √ √ √ √ Server 27/05/19 No impact performed.
1 As there is daily, weekly, monthly
Control CPGB/QC/HPL/08 02/02/19 √ √ √ √ Server 27/05/19 No impact and yearly backup available in server
CPGB/QC/HPL/09 27/02/19 √ √ √ √ Server 27/05/19 No impact and manual backup also taking from
starting of the project creation.
CPGB/QC/GC/01 04/09/18 √ √ √ √ Server 27/05/19 No impact Hence no impact on the data
CPGB/QC/AUT-01 11/07/18 x √ √ x Server 15/06/19 No impact availability.
CPGB/QC/KF-01 10/07/18 x √ √ x Server 15/06/19 No impact
CPGB/QC/CC-01 09/08/18 x √ √ x Server 17/05/19 No impact
CPGB/QC/CC-02 09/08/18 x √ √ x Server 17/05/19 No impact

Page 4|8
Comprehensive review of instruments & equipment’s to access the impact based on deviation
CPGB/QC/FTC-01 22/08/18 x √ √ x Server 17/05/19 No impact
CPGB/QC/PSC-01 27/09/18 x √ √ x Server 17/05/19 No impact

STANDALONE SYSTEMS

CPGB/QC/FTR-01 x √ √ x Standalone 22/07/19 No impact

19/07/18
CPGB/QC/UV-01 26/07/18 x √ √ x Standalone 22/07/19 No impact
Manual backup has been taking from
starting of the project creation.
Quality CPGB/QC/PLM-01 17/08/18 x √ √ x Standalone 22/07/19 No impact Hence no impact on the data
Control availability. Manual backup has been
CPGB/QC/TOC-01 05/07/18 x √ √ x Standalone 22/07/19 No impact taking from starting of the project
creation. Hence no impact on the
CPGB/QC/IC-01 26/09/18 x √ √ x Standalone 22/07/19 No impact data availability

CPGB/QC/AAS-01 05/11/18 x √ √ x Standalone 22/07/19 No impact

Page 5|8
Comprehensive review of instruments & equipment’s to access the impact based on deviation

IMPACT EVALUATION - MICROBIOLOGY:

Back up Data
Equipment / Actual
Qualification (Server/Stand availability
S. Autoback Potential
Dept. Instrument / alone) (Server/ Remarks
No date up taken Impact
Identification code standalone
D W M Y on
status)
CPGB/MB/VK-01 16/11/18 x x x x Standalone NA No impact Not in Network/ Server,
manual backup taking by
CPGB/MB/LPC-01 01/02/19 x √ √ x Standalone 22/07/19 No impact
external drive
CPGB/MB/INC-01 10/08/18 x √ √ x Server 17/05/19 No impact
Backup has been taken.
CPGB/MB/INC-02 10/08/18 x √ √ x Server 17/05/19 No impact
Hence no impact on the data
availability
CPGB/MB/INC-03 20/08/18 x √ √ x Server 17/05/19 No impact

2 Microbiology CPGB/MB/INC-04 13/08/18 x √ √ x Server 17/05/19 No impact

CPGB/MB/INC-05 10/08/18 x √ √ x Server 17/05/19 No impact

CPGB/MB/INC-06 10/08/18 x √ √ x Server 17/05/19 No impact Backup has been taken.
Hence no impact on the
CPGB/MB/CC-01 10/08/18 x √ √ x Server 17/05/19 No impact data availability
CPGB/MB/DF-01 18/09/18 x √ √ x Server 17/05/19 No impact

CPGB/MB/WIC-01 23/04/19 x √ √ x Server 17/05/19 No impact

Page 6|8
 Comprehensive review of instruments & equipment’s to access the impact based on deviation
CPGB/MB/WIC-02 30/04/19 x √ √ x Server 17/05/19 No impact

CPGB/MB/HSS-01 04/01/19 x x x x Standalone NA Impact

IMPACT EVALUATION OTHER AREAS:

Back up
Equipment / Data availability
Qualification (Server/ Stand
Dept. Instrument / (Server / Actual back Potential
S. No date alone) Remarks
Identification code standalone up taken on Impact
status)
D W M Y
CPGB/PRI/ONV-01 NA x x √ x Standalone NA No impact
CPGB/PRI/FIT-01 NA x x √ x Standalone NA No impact
CPGB/PRI/VAT-01 NA x x √ x Standalone NA No impact
3 PRI CPGB/PRI/VWM-01 NA x x √ x Standalone NA No impact
CPGB/PRI/STS-01 NA x x √ x Standalone NA No impact Production instruments
CPGB/PRI/VSM-01 NA x x √ x Standalone NA No impact not connected to
Servers.
CPGB/PRI/VFS-01 NA x x √ x Standalone NA No impact
Hence no impact
4 QA Stability Chambers NA x x √ x Standalone NA No impact
CPPB/PPK/YCC-01 NA x x √ x Standalone NA No impact
5 PPK
CPPB/PPK/VLM-01 NA x x √ x Standalone NA No impact
6 EN CPUS/EN/CBT-01 NA x x √ x Standalone NA No impact

Page 7|8
 Comprehensive review of instruments & equipment’s to access the impact based on deviation

CPUS/EN/PWO-01 NA x x √ x Standalone NA No impact

CPUS/EN/PWG-01 NA x x √ x Standalone NA No impact
CPUS/EN/PWD-01 NA x x √ x Standalone NA No impact
Network connection
upon restore, the data for
the network down time
was from 10:30 to 19:00
hours of 17/08/19. Hence
CPUS/EN/EMS-01 14/06/19 x x √ x Standalone NA No impact EMS data is not
captured. In parallel,
there is manual
monitoring in the areas.
No outages were
reported in the
manufacturing areas.
N N N N
7 PRT NILL NA NA NA NA NA
A A A A

Page 8|8