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Arnold Edrick, Fajar Sidik, M.Thoha, Ruri Nitrita, Angga Lazuardy, Narya Wijaya
23-24 September 2019
Hardware Categories
01
Agenda 02 Software Categories
Benefit
03
Standard
Ready to use hardware/
01 infrastructure
Custom
Specially design hardware
specification (DS) must be available
02
Form an integrated environment for “Out of the box product” / “Off the
running and support application shelf product”
and service.
Used by default configuration or else
called parameterization
GAMP 5
Software
Categories
Category 4 – Configured Product
Category 5 – Custom Application You can simply impress your
audience and add a unique zing
Developed software using scripting and appeal to your Presentations.
language to satisfy specific business Easy to change colors, photos.
needs.
23-24 September 2019
•Software Categories 1
System Build
23-24 September 2019
• CSV Component
1. System overview
1. Purpose 2. System architecture
2. System overview 1. System overview 1. Deviation
3. Data & access
3. System Requirement 2. Scope 2. Justification of
management
4. Functional 3. Responsibilities deviation
4. Security matrix
Specification 4. Test plan and 3. Result
5. Process description
5. Technical procedure 4. Conclusion
6. Infrastructure &
Specification 5. Recommendation
software
6. Design Specification 7. Reference document
8. Risk analysis
URS
2.5 Audit trail will record the specific ID start from login until logout with
provided audit trail reporting function in unchangeable format for every
action been done in the system
2.4 During HPLC running a sample no electrical shortage will affect the
system for until minimum of 24hours
Requirements
Point 2 in the 2.5 Limited access to the system using security matrix divided per level
document of access with 2 points verification (ID and password)
2.6 Audit trail will record the specific ID start from login until logout with
provided audit trail reporting function in unchangeable format for every
action been done in the system
a.Recipe management
GxP Risk
ID Process step Risk scenario Action
consequences level
1. System OQ: Test plan to
architecture Recipe management verify the data set
(According to system Wrong set of from ERP
Serialization The data set from
Client PC
architecture recipe data will lead to transferred
2.1.a ERP will not be C
for serialization will incorrect serial successfully and
transferred correctly
be interfaced from code generation correctly in the
ERP) Serialization client
PC
Protocol
Acceptance Criteria
Successful backup and restore sequence
Results
Point 4 – backup result
Conclusion:
23-24 September 2019
• CSV Component Report
Report
Test Description
1. user ID (empty) and correct password
2. Verify that it cannot login
3. Type valid user ID and incorrect password
4. Verify that it cannot login
Acceptance Criteria Evidence
Results
Testing 2 - Backup Restore
This function is for the project database and the log database can be backed up. HPLC Report
Test Objective
To ensure the user with proper rights can use this function.
Test Description
1. Login to LabSolutions as System Administrator
2. Click the [Administration] icon and select the [Backup] by clicking the icon to
start the Backup program.
3. Select 1 or more data from database
4. Verify that the [Backup] function is working
5. Login to LabSolutions as System administrator
6. Click the [Administration] icon and select the [Restore] by clicking the icon to
start the Restore program
7. Verify that the [Restore] function is opened to start the [Restore].
8. Verify that the restore result
Acceptance Criteria
Successful backup and restore sequence
Results
Point 4 – backup result
Point 8 – Restore result
Conclusion:
Template URS
Purpose
(Indicate the wished key objectives and benefits and ensure that these
benefits are covered by the specific requirements included in section 3 and
1.
satisfied using indexes/percentages of improvement.)
Example: 5% of improvement process efficiency.
System overview
2. (Summary of system main function)
3. System Requirement
3.1 Data management (scope backup-restore, data saving, data modification)
3.2 Access level requirement
3.2 ALCOA+ requirement
3.3 Business requirement
3.4 Technical requirement (utility, space, ducting)
3.5 HSE requirement
3.6 Document / Certificate requirement
Template Risk Assessment
ID
(refer to Requirement/ GxP Risk Action
Risk scenario
requirement) process flow consequences level (IQ/OQ/PQ)
1.
2.
3.1
3.2
…
Template IQ Protocol
Protocol
Observations /
Pass/Fail/Pass
No. Action Expected Result Deviations / Sign / Date
with notes
Attachments
I. Sub section of IQ Protocol (system installation condition) / hardware specification / software specification / supporting procedure
/vendor document and certification
1. Verify Procedure … in place Procedure … in place Procedure number : XXxXX Pass ßÀ© 24 Sep 2019
2.
3.
…
Observations /
No. Action Expected Result Deviations / Pass/Fail Initials / Date
Attachments
II. Sub section of IQ (system installation condition) / hardware specification / software specification / supporting procedure / vendor
document and certification
Installed according to
4. UPS installed UPS brand, specification expected result Pass ßÀ© 24 Sep 2019
5.
6.
..
Template OQ Protocol
Test 1 Test 2
General test title General test title
Test Objective Test Objective
what function that this test wanted to introduce/ what function that this test wanted to introduce/
challenged challenged
Test Description Test Description
1. Test step or process to achived objective 1. Test step or process to achived objective
2. 2.
3. 3.
4. 4.
… …
Acceptance Criteria Acceptance Criteria
Result of the test that we are hoping to meet Result of the test that we are hoping to meet
requirements requirements
Results Results
Result
Attachment 1 - Evidence (screenshot)
Attachment 2 - Evidence (screenshot)
Conclusion
The system valid or not
Recommendation
Any observable recommendation
THANK YOU