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Computerized System Validation

The document outlines a validation protocol for Minitab 17 software. It describes testing the computer hardware, operating system software, Minitab application software, and process capability index calculations in Minitab to verify they meet specifications and operate as intended. The objective is to qualify Minitab 17 for use at PT. Caprifarmindo Laboratories. Tests include checking hardware and software specifications and comparing process capability index calculations in Minitab to those calculated manually in Excel. Successful testing will verify Minitab operates properly and produces accurate results.

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Eka Oktawiguna
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373 views14 pages

Computerized System Validation

The document outlines a validation protocol for Minitab 17 software. It describes testing the computer hardware, operating system software, Minitab application software, and process capability index calculations in Minitab to verify they meet specifications and operate as intended. The objective is to qualify Minitab 17 for use at PT. Caprifarmindo Laboratories. Tests include checking hardware and software specifications and comparing process capability index calculations in Minitab to those calculated manually in Excel. Successful testing will verify Minitab operates properly and produces accurate results.

Uploaded by

Eka Oktawiguna
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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COMPUTERIZED SYSTEM

VALIDATION
MINITAB 17 VALIDATION PROTOCOL
Outline

Computerized System Validation (CSV)

Minitab 17

Objective and Scope

Critical Parameter

Performance Qualification Test


Computerized System Validation (CSV)
Minitab 17
Objective

• The purpose of this Minitab validation protocol is to


provide documented verification that the Minitab is
able to be operated according to the predetermined
specification by lay down the procedure for carrying
out validation of Minitab.
Scope

• This protocol covers all aspects for Minitab that located at PT.
Caprifarmindo Laboratories, Cimareme.
• This protocol will define the methods and documentation used to
qualify the Minitab.
• The re-validation of Minitab will be performed concurrently.
• Successful completion of this protocol will verify that the aMinitab
is working properly and result as per
Critical Parameter

• Function Process Capability Index (Cpk)


Values of Cpk Result
0 < Cpk ≤ 1 Process is poorly capable of
producing aimed results statistically
1 < Cpk ≤ 1.33 Process is statistically capable but
indicate the need of improvement

1.33 < Cpk ≤ 1.67 Process is statistically capable


producing aimed results
Cpk > 1.67 Process is much better than
needed to meet the limitst
Performance Qualification Test

Hardware Software Process


Verification Verification Capability
Test Test Index Test
Hardware Verification Test
Objective:
Description: PC Workstation
to ensure the computer hardware
Minimum specification required for the system.
Actual Verified All of the as found conditions comply
Aspect Requirement Pass/Fail
Specification By/Date with specifications and properly tagged
Specification
or identified and installed as specified.
Manufacturer Intel Corporation
Procedure:
Processor Intel Pentium 4 Check brochure or manual book to
ensure the computer hardware tagged
512 MB Recomended or indentified and installed as
Memory
1+ GB specification.
Harddisk 2 GB
Acceptance Criteria:
For computer hardware of Minitab, all
the as-found conditions shall comply
with the manufacture specifications
Software Verification Test
Objective:
Description: Operating System
to ensure that the software required for
Minimum minitab, all as found conditions comply
Actual Verified
Aspect Requirement Pass/Fail with specifications, and that the
Specification By/Date
Specification software required for this system are
Manufacturer Microsoft Corporation installed as specified.
Microsoft Windows 7
Model Procedure:
or Higher
Check brosure or manual book to ensure
Version Servis Pack 1 the computer software installed as
Serial/ specification, list of the model, version,
License N/A serial or license number
Number
Acceptance Criteria:
Software specification required for
Minitab comply with manufacture
specification
Software Verification Test
Description: Application Software

Minimum Requirement Actual Verified


Aspect Pass/Fail
Specification Specification By/Date
Manufacturer N/A

Model Minitab

Version 17.2.1
Serial/
License N/A
Number
Process Capability Index Test The value displayed on the Minitab
1. Ensure that Excel is on expected to equal to that produced
2. Sort out three quantitative by the Excel calculation
test from selected batchs There should not be any difference
from Minitab in 2nd decimal
3. Checking calculation with
an Excel by the manual
formula Acceptance
4. Fill out the form on the
observation Criteria:
Data
Review:
Test 1. The results of the test shall be
Procedure: recorded on the protocol sheets
Objective: titled ‘Calculation Test Form’.
2. The protocol sheet shall be
to ensure that the reviewed and approved by PT. Sanbe
process capability Farma Unit 3 or nominated
index test for representative.
minitab is working 3. The completed and approved
properly and result protocol sheet shall be appended to
as per requirement this Performance Qualification.

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