Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.

L&R
718 Shipping & Customer Service Version: 1

Local Installation and Performance Qualification Report

Launching/Receiving on <unique computer ID>

TMD System, software TTC, version 4.0

Temperature Monitoring Device

Encl.: Enclosure A: Configuration Item List, xx pages

Enclosure B: Local Installation/Performance Qualification Protocol
Launching/Receiving on <unique computer ID>, xx pages

Enclosure C: Filled out test cases, xx pages

Enclosure D: Computer generated documentation, xx pages
Enclosure E: Validation non conformities, xx pages

Prepared by:

<Name> Date: Signature:

<Init.> ___________ ___________________________
<Title>
<Dept. name>

Reviewed by:

<Name> Date: Signature:

<Init.> ___________ ___________________________
<Title>
<Dept. name>

Approved by:

<Name> Date: Signature:

<Init.> ___________ ___________________________
Unit QA
<Dept. name>

TMD – Temperature Monitoring Device Page 1 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt
Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.L&R
718 Shipping & Customer Service Version: 1

Table of Contents

1. Objective.....................................................................................................3
2. Scope..........................................................................................................3
3. Definitions and Abbreviations......................................................................4
4. Responsibilities...........................................................................................4
5. Results........................................................................................................4
5.1 Summary of Activities and Results..........................................................4
5.2 Summary of Validation non Conformities................................................4
5.3 Baseline and Result of Comparison........................................................5
6. Conclusion.................................................................................................. 5
7. References..................................................................................................5
Change Log.........................................................................................................6

TMD – Temperature Monitoring Device Page 2 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt
Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.L&R
718 Shipping & Customer Service Version: 1

Please perform the following updates of this template:

1. In the header of this document (see above) fill in department no., department name, computer id
and document version as follows:

Novo Nordisk A/S Internal No.: <Dept. no.>.LIQPQR.TMD.<unique computer id>

<Dept. no. and name> Version: <version>

Example:

2. In document fill in all highlighted fields with relevant local information or where relevant remove
highlighted fields.

3. In document perform other relevant updates to align to local conditions

NB! Remember also to delete this text box

1. Objective
This report is written to conclude on the completed local validation of the TMD
system at <dept. name>.

2. Scope
This report concludes on qualification of the TMD system on the specified PC.
After successful execution of the protocol, the system is validated for launch
and/or download of TT devices for shipment of temperature sensitive products.

This qualification has been executed on the following computer:

 <unique computer ID>

This local installation and performance qualification report summarizes the

result of the local qualification for the TMD system, executed according to the
local installation and performance qualification protocol, ref. [1].

The central validation report, ref. [2], summarizes the result of the central
qualification for the TMD system.

TMD – Temperature Monitoring Device Page 3 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt
Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.L&R
718 Shipping & Customer Service Version: 1

3. Definitions and Abbreviations

Definition/Abbreviation Description
CIL Configuration Item List.
TMD Temperature Monitoring Device
TT TempTracer
TTC TempTracer Centre.The PC based software application at each
sending dispatching and receiving site used to launch and
download TempTracers.
VNC Validation Non Conformity

4. Responsibilities
The roles and responsibilities in relation to the local qualification effort are
described in ref. [1].

5. Results

5.1 Summary of Activities and Results

The test cases in the table below have been executed in the local
installation and performance qualification of computer <Unique computer
ID>.

The final conclusion of each test case is stated in the right most column.

Test Areas Test Cases Final conclusion

Description ID Description Accepted?
Test Area 1: 1.1 Baseline – compare CIL with Yes 
Computer used to launch actual computer system No 
TempTracer
Test Area 2: 2.1 Launching functionalities Yes 
Computer used to launch No 
TempTracer
Test Area 2: 2.2 Receiving functionalities Yes 
Computer used to receive No 
TempTracer

5.2 Summary of Validation Non Conformities

The validation non conformities in the table below have been observed
during the local installation and performance qualification of computer
<Unique computer ID>.

TMD – Temperature Monitoring Device Page 4 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt
Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.L&R
718 Shipping & Customer Service Version: 1

VNC ID Test Area, Case, Step Priority Short description

Column Priority: The following classifications apply

High: High priority, the validation non conformity found must be
solved before proceeding with the qualification
Medium: Medium priority, the validation non conformity found
should be solved but it may happen at a later time.
Low: Low priority, the error found may be solved.

5.3 Baseline and Result of Comparison

A baseline for the computer used for launch activities was established
during execution of test case 1.1. The resulting CIL is enclosed as
Enclosure A.

6. Conclusion
All ‘Actual Results’ are equal to ‘Expected Results’ or accounted for in a
validation non conformity form, and all validation non conformities have been
closed and approved by unit QA.
Consequently the acceptance criterion for the local qualification has been met.

The TMD system on <unique computer ID> is considered fully validated for
shipment and receipt of products, and is hereby now ready for use.

7. References
Ref. no. Document title
[1] Internal no. <Dept. no.>.LQP.TMD.<unique computer id>: Local
Installation/Performance Qualification Protocol, Launching/Receiving
[2] Internal no. 718.VPR.TMD.TTC4, Validation Report
Table 7.1: References.

TMD – Temperature Monitoring Device Page 5 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt
Novo Nordisk A/S Internal No.: 718.LIQPQRT.TMD.L&R
718 Shipping & Customer Service Version: 1

Change Log

Vers. Date Reason for revision Revised without

changes
Date/Sign.
1 <Date> New document.

TMD – Temperature Monitoring Device Page 6 of 6

Internal No.: 718.LIQPQRT.TMD.L&R, version: 1
Template for Local Installation/Performance Qualification Report, launch and receipt