The objective of this operational qualification protocol is to verify that the LogiLAB SDMS is fit for its intended use.
Each section provides a result area to document the outcome of the procedural elements.
Screenshots will be taken as evidence of all actual results, annotated appropriately, and attached to the executed protocol. The attachments will be referenced in each section.
The Discrepancy Log is to be completed for any discrepancies recorded in the outcome of the procedure execution.
The Attachment Log is to be completed to list any attachments/records used during the procedure execution or generated as protocol execution output.
Company Name: | |
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Department: | |
Contact: |
This procedure is intended to verify that the software is functional and fit for use.
Validation of the functionality of the LogiLAB SDMS modules for their intended use.
Acronym/Initials |
Meaning |
CFR |
Code of Federal Regulations |
FDA |
Food & Drug Administration. |
CGMP |
Current Good Manufacturing Practice |
HTML |
Hypertext Markup Language |
LAN |
Local Area Network |
IQ |
Installation qualification |
IIS |
Internet Information Server |
N/A |
Not applicable |
N/AV |
Not available |
N/S |
Not specified |
OQ |
Operational qualification |
PC |
Personal Computer |
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Portable Data File |
QA |
Quality Assurance |
QC |
Quality Control |
SOP |
Standard Operating Procedure |
UPS |
Uninterruptible Power Supply |
LIMS |
Laboratory Information Management System |
BLOB |
Binary Large Objects |
DSN |
Domain Source Name |
TCP/IP |
Transmission control Protocol / Internet Protocol |
ASCII |
American Standard Code for Information Interchange |
SDMS |
Scientific Data Management System |
FTP |
File Transfer Protocol |
DB |
Database |
6.2.5 Providing trained users, specialists, and technical support, as required for the preparation, review, and execution of this qualification protocol.
APPSVR |
Date: 27-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
NOTE: All the fields in this page are mandatory.
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
NOTE: Drive Path is created during FTP site configuration
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
NOTE: Make sure the FTP Configuration Service is configured and running.
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Record will be added
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
NOTE: Create an Administrator group with all rights and other user groups with required privileges prior to executing the action steps.
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: |
Reviewed By: |
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Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
26.1.4 Select a tag in the Master Tag List and add it to the Tag hierarchy list.
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 28-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
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Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Date: 30-07-2019 |
Reviewed By: |
Vijay Dhamanaskar |
Pass o / Fail o |
| |
Comment: Pass | ||
Attachment / Screenshot: Refer Annexure- B |
Discrepancy No. |
Test ID |
Discrepancy Tile |
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Att. No. |
Description |
No. Of Pages |
Document |
1 |
LogiLAB SDMS Operational Qualification Supporting Document. |
74 |
Annexure-B |
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