PROTOCOL No.

:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 1 of 13

ALARM VERIFICATION

REPORT

FOR

INCUBATORS

(MICROBIOLOGY, Q-BLOCK)

EQUIPMENT ID. No.

Incubation Room, Microbiology Section
LOCATION
Q-Block
DATE OF QUALIFICATION

SUPERSEDES PROTOCOL No. NIL

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 2 of 13
REPORT CONTENTS

S. NO. CONTENTS PAGE No.

1. PRE APPROVAL 3

2. OBJECTIVE 4

3. SCOPE 4

4. RESPONSIBILITY 4

5. REASON FOR STUDY 5

6. SITE OF STUDY 5

7. EQUIPMENTS DETAILS 5

8. SYSTEM DESCRIPTION 5

9. PRE-QUALIFICATION REQUIREMENTS 6

10. ALARM VERIFICATION TEST RESULTS 8

11. CHECKLIST OF ALL TESTS 10

12. DOCUMENTS TO BE ATTACHED 10

13. NON COMPLIANCE 10

14. DEVIATIONS FROM PREDEFINED SPECIFICATIONS, IF ANY 11

15. CHANGE CONTROL, IF ANY 11

16. REVIEW (INCLUSIVE OF FOLLOE UP ACTION, IF ANY) 11

17. CONCLUSION 11

18. RECOMMENDATION 11

19. ABBREVIATIONS 12

20. POST APPROVAL 13

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 3 of 13
1.0 PRE APPROVAL:

PREPARED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

OPERATING MANAGER
(QUALITY ASSURANCE)
HEAD
(QUALITY CONTROL
/ MICROBIOLOGY)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 4 of 13
2.0 OBJECTIVE:
 To provide documented evidence that the Equipment is performing consistently, repeatedly and
reproducibly within its established operating range and the results of all the test parameters meet the
pre-defined acceptance criteria.
 To confirm the suitability of the Standard Operating Procedures for all routine activities associated
with the system.
 To compile the data of Alarm Verification carried out as per the general protocol no.-H/GNP/0119-
00 in Incubation area of Microbiology of Q-Block.
3.0 SCOPE:
 This Report is prepared to Challenge the Audio Visual Alarm system in Microbiology Section of I
block at Pure & Cure Healthcare Pvt. Ltd., Haridwar.
 This activity is trigger against the Change Control No.-CC/H-I/QC/20/0294

4.0 RESPONSIBILITY:
The verification study group, comprising of a representative from each of the following departments,
shall be responsible for the overall compliance of this report:

DEPARTMENTS RESPONSIBILITIES
 Preparation, Review, Approval and Compilation of the
Verification Report.
 Co-ordination with Engineering and Production to carryout
Quality Assurance
Verification Activity.
 Monitoring of Verification Activity.
 Post approval of Activity after execution.
 Review of Verification Report.
Microbiology  To Execute Verification Activity.
 Post review of Verification Report report after execution.
 Reviewing of Verification Report for correctness,
completeness and technical excellence.
 Responsible for trouble shooting (if occurred during
Engineering
execution).
 Maintenance & preventive maintenance as per schedule.
 Post review of Verification Report after execution.

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 5 of 13
5.0 REASON FOR STUDY:
 This activity is trigger against the Change Control No.-CC/H-I/QC/20/0294

6.0 SITE OF STUDY:

 Microbiology Laboratory, Q-Block, Pure and Cure Healthcare Pvt. Ltd. Haridwar

7.0 EQUIPMENT DETAILS:

Following are the key detail of incubator and temperature limit.

S. NO. INCUBATOR ID. TEMP. LIMIT

1. PC/INS/S-39/01 55-60°C

2. PC/INS/S-39/02 35-39°C

3. PC/INS/S-39/03 42-44°C

4. PC/INS/S-39/04 55-60°C

5. PC/INS/S-39/05 20-25°C

6. PC/INS/S-39/06 30-35°C

7. PC/INS/S-39/07 20-25°C

8. PC/INS/S-39/08 30-35°C

9. PC/INS/S-39/09 35-39°C

8.0 SYSTEM DESCRIPTION:

 The Temperature monitoring system contains Control Panel box, Temperature Sensors and Audio
Visual Alarm Unit in Incubation area. The Audio visual alarm system is provided to indicate the
user when temperature of the incubator chamber goes beyond specific temperature.
 The System consists of following Parts:-

 Temperature Sensors

 Control Panel Box

 Audio Visual Alarm Unit in Incubation area.

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 6 of 13

9.0 PRE – QUALIFICATION REQUIREMENTS:

9.1 Training:
The Training for the entire concerned person shall be provided and record shall be attached with
the qualification report.

*Training Evaluation
Trainee
S. No Name of Trainee Designation (Satisfactory / Not
(Sign. / Date)
Satisfactory)

Training Given By:

Sign & Date
*Note: Training evaluation shall be done on the basis of oral assessment.

Inference:
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
Reviewed By: ______________
Manager QA
Sign/Date

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 7 of 13

9.2 Verification of Documents:

Record the observations for documents in

the below mentioned table.
Checked By QA
S. No. Document Name SOP No.
Sign/Date

Inference:
………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

Reviewed By: ______________

Manager QA
Sign/Date

9.3 Calibration Status Verification:

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

Inference:

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 8 of 13
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………

Reviewed By: ______________

Manager QA
Sign/Date

10.0 ALARM VERIFICATION TEST RESULTS:

The method of Challenge test of alarm system is described in the below table temperature wise,
photograph of execution of challenge method shall be taken and attached along with report.
S. Incubator Temp.
Case Method
No. Id. Limit
When Challenge Lower Set the lower limit value more than the display
1. PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
55-60°C
39/01 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
2. 35-39°C
39/02 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
3. 42-44°C
39/03 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
4. 55-60°C
39/04 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
5. 20-25°C
39/05 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
6. 30-35°C
39/06 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
7. 20-25°C
39/07 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
8. 30-35°C
39/08 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.
FORMAT NO.: QAH-093/F07-02
 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 9 of 13
When Challenge Lower Set the lower limit value more than the display
PC/INS/ S- Limit value of temperature. value. Alarm will blow for lower limit challenge.
9. 35-39°C
39/08 When Challenge Upper Set the Upper limit value less than the display
Limit value of temperature. value. Alarm will blow for Upper limit challenge.

Date of Test: ____________

10.1 Alarm verification while Challenging the Lower set limit of temperature:
Temperature Setting up lower Complies/
Temperature Done
S. No. Equipment Id Display value Temp. Limit More than Observation of Alarm not
Limit By
(oC) display value (oC) complies
1. PC/INS/ S-39/01 55-60°C
2. PC/INS/ S-39/02 35-39°C
3. PC/INS/ S-39/03 42-44°C
4. PC/INS/ S-39/04 55-60°C
5. PC/INS/ S-39/05 20-25°C
6. PC/INS/ S-39/06 30-35°C
7. PC/INS/ S-39/07 20-25°C
8. PC/INS/ S-39/08 30-35°C
9. PC/INS/ S-39/09 35-39°C
10.2 Alarm verification while Challenging the Upper set limit of temperature:
Temperature Setting up Upper Complies/
Temperature Done
S. No. Equipment Id Display value Temp. Limit Less than Observation of Alarm not
Limit By
(oC) display value (oC) complies
1. PC/INS/ S-39/01 55-60°C
2. PC/INS/ S-39/02 35-39°C
3. PC/INS/ S-39/03 42-44°C
4. PC/INS/ S-39/04 55-60°C
5. PC/INS/ S-39/05 20-25°C
6. PC/INS/ S-39/06 30-35°C
7. PC/INS/ S-39/07 20-25°C
8. PC/INS/ S-39/08 30-35°C
9. PC/INS/ S-39/09 35-39°C
Acceptance Criteria:
 Audio visual Alarm with red light indicator shall be generated.
Checked By: ______________ Verified By: ______________
Microbiology Quality Assurance
FORMAT NO.: QAH-093/F07-02
 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 10 of 13
Sign/Date Sign/Date
Inference:
…………………………………………………………………………………………………………..
………………………………………………………………………………………………………………
……..
Reviewed By: _____________
Manager QA
Sign/Date

1.0 CHECKLIST OF ALL TESTS:

This checklist is provided to ensure that all tests or checks required for this report have been executed.

TESTS OR CHECKS EXECUTED [YES / NO] REMARK

Alarm Verification

Checked By: ______________ Verified By: ______________

Microbiology Quality Assurance
Sign/Date Sign/Date

Inference:
…………………………………………………………………………………………………………..
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
……

Reviewed By: _____________

Manager QA
Sign/Date

2.0 DOCUMENTS TO BE ATTACHED:

……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 11 of 13
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

3.0 NON COMPLIANCE:

……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

4.0 DEVIATION FROM PREDEFINED SPECIFICATIONS, IF ANY:

……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

5.0 CHANGE CONTROL, IF ANY:

……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

6.0 REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY):

……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

7.0 CONCLUSION:
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
FORMAT NO.: QAH-093/F07-02
 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK) REVISION NO.: 00
PAGE No.: 12 of 13
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

8.0 RECOMMENDATION:
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………

9.0 ABBREVIATIONS:
o
C : Degree centigrade
GNP : General Protocol
GNR : General Report
CC : Change Control
QC : Quality Control
QA : Quality assurance
SOP : Standard operating procedure
ID. : Identification Number
INS : Instrument
Ltd. : Limited
No. : Number
QB : Q- Block

FORMAT NO.: QAH-093/F07-02

 PROTOCOL No.:
PURE & CURE ALARM VERIFICATION REPORT
H/GNP/0119
HEALTHCARE FOR REVISION NO.: 00
PVT. LTD., INCUBATORS REPORT No.:
H/GNR/0119
HARIDWAR (MICROBIOLOGY, Q-BLOCK)
REVISION NO.: 00
PAGE No.: 13 of 13
10.0POST APPROVAL:

PREPARED BY:

DESIGNATION NAME SIGNATURE DATE

OFFICER/EXECUTIVE
(QUALITY ASSURANCE)

REVIEWED BY:

DESIGNATION NAME SIGNATURE DATE

OPERATING MANAGER
(QUALITY ASSURANCE)
HEAD
(QUALITY CONTROL
/ MICROBIOLOGY)
HEAD
(ENGINEERING)

APPROVED BY:

DESIGNATION NAME SIGNATURE DATE

HEAD
(QUALITY ASSURANCE)

FORMAT NO.: QAH-093/F07-02