Validation Approach and Scope for
Business Process System Validation
Epitome Technologies Private Limited
Table Of Contents:
1.0 GENERAL ... 3
2.0 SCOPE – MODULES COVERED ... 3
3.0 QUALIFICATION APPROACH ... 3
3.1 APPROACH FOR IMPLEMENTED SYSTEM ... 3
4.0 MAJOR STEPS ... 3
4.1 DOCUMENT USER REQUIREMENTS SPECIFICATIONS ... 3
4.2 DEVELOP VALIDATION MASTER PLAN... 4
4.3 GAP ANALYSIS ... 4 4.4 RISK ASSESSMENT ... 4 4.5 INSTALLATION QUALIFICATION ... 4 4.6 NETWORK QUALIFICATION ... 4 4.7 OPERATIONAL QUALIFICATION ... 4 4.8 PERFORMANCE QUALIFICATION ... 4 4.9 DOCUMENTATION ... 4
5.0 GAP ANALYSIS PROCESS ... 4
5.1 PURPOSE ... 4
6.0 RISK ASSESSMENT PROCESS ... 5
6.1 RISK ASSESSMENT ASSOCIATED WITH BUSINESS PROCESS SYSTEM ... 5
7.0 SYSTEM QUALIFICATION ... 5
7.1 INSTALLATION QUALIFICATION (IQ) ... 5
7.2 NETWORK QUALIFICATION (NQ)... 5
7.3 OPERATIONAL QUALIFICATION (OQ) ... 5
7.4 PERFORMANCE QUALIFICATION (PQ) ... 6
7.5 QUALIFICATION DISCREPANCY REPORT ... 6
7.6 VALIDATION REPORT... 6
7.7 TRACEABILITY MATRIX ... 6
8.0 PARTIAL LIST OF CLIENTS... 7
1.0 GENERAL
Epitome undertakes various Computer System Validation projects in the areas of Process Control Systems, Laboratory Computerized Systems and Global Information Systems. Following GAMP guidelines, Epitome ensures compliance to major International Agencies like US FDA / MHRA / TGA etc for Computer System Validation.
This document covers an overview of “Typical Approach to Validation of Business System under use”. This will out line the scope of work, methodology, references etc.
2.0 SCOPE – MODULES COVERED
Modules generally covered for validation are given below a) Material Management
b) Quality Management
c) Production Planning Management d) Sales & Distribution Management e) Plant Maintenance Management f) Human Resources ( Part )
ERP systems being multi location / multi facility set up, it is imperative that each section handling cGMP critical transaction for regulated market is addressed in the process of computer system validation. The severity of testing and scope for complexity can be determined on the basis of criticality of each set up.
3.0 QUALIFICATION APPROACH
3.1 Approach For Implemented System
The approach generally considered for implemented Business Systems is CONCURRENT approach as the system is already under use. During the process, efforts are made to find out available information on specifications, documentation and current practices of the organization. Based on that, further activities are planned.
For every system which is implemented and under use, the model considered is SILC- Software Implemented Life Cycle based on GAMP guidelines.
Validation generally follows the steps as listed below:
4.0 MAJOR STEPS
The following para describes various activities generally covered in validation of Business Process Systems.
4.1 Document User Requirements Specifications
User Requirements document is developed as part of this validation effort. This version-controlled document formally specifies Client’s intended uses for the ERP System.
4.2 Develop Validation Master Plan
A validation master plan is developed to describe the objectives, scope, approach and responsibilities for the Business Process System validation. The validation plan gets approved before any of the protocols are approved.
4.3 GAP Analysis
GAP Analysis to be performed on the existing system validation documents, technical and design documents, required standard operating procedure and existing qualification report. On completion of the analysis any errors found in the documentation or system it should be concluded and then only further qualification activity proceed.
4.4 Risk Assessment
To identify the various risk related to cGMP to operate the Business Process System. During this activity, the system design is evaluated and if the risk cause is not considered in the design then suitable mitigation and change in the system is recommended. All risk identified during assessment process is challenged during the operation qualification.
4.5 Installation Qualification 4.6 Network QualificaTion 4.7 Operational Qualification 4.8 Performance Qualification 4.9 Documentation
On completion of ERP software system qualification, following documents are made available as an evidence of validation activity:
• Validation Master Plan. • GAP analysis report.
• Recommended action plan for serious gaps closures. • Risk assessment report.
• Installation qualification report. • Network qualification report. • Operation qualification report. • Performance qualification report. • Deviation reports.
• Qualification summary report. • Traceability Matrix.
5.0 GAP ANALYSIS PROCESS
5.1 Purpose
To identify the gaps of implemented Business Process system and IT infrastructure.
During GAP analysis, a detailed checklist is prepared for the system. Also, the Checklist is reviewed before the analysis, evaluation and observation. Following points (but not limited to) are generally covered for the preparation of checklist for GAP analysis:
• Review the validation documents for existing application software. • Review the design and technical documents.
• Review the documents for Standard operating procedures of the system. • Process GAP for individual process function wise.
• System hardware design and installation. • Network Infrastructure GAP.
As a result of this activity system gaps are identified. The gaps generally could be
- Lack of Documentation and Adequacy - Deficiency in IT Infrastructure
- cGMP definition in implementation
6.0 RISK ASSESSMENT PROCESS
The focus of the risk assessment is to assess those risks associated with the process/ operation of the system. The risk assessment process allows users to identify and minimize the impact of adverse events, while at the same time providing the necessary justification for the validation approach taken to support the system qualification.
6.1 Risk Assessment Associated With Business Process System
a. Identify GMP risk b. Identify risk scenarios c. Assess likelihood
d. Assess the severity of impact e. Assess probability of detection f. Overall priority
g. Appropriate measure for risk
7.0 SYSTEM QUALIFICATION
7.1 Installation Qualification (IQ)
IQ protocol is developed to verify and document that all critical aspects of the systems functions has been installed in accordance with the approved system specifications, manufacturer’s specifications and as-built documentation.
7.2 Network Qualification (NQ)
Network qualification (NQ) is associated with the network infrastructure of the ERP system and is carried out as part of Installation Qualification. Functions are verified to establish that the hardware and system software is installed in accordance with design and vendor/manufacturer recommended practices.
7.3 Operational Qualification (OQ)
OQ protocol is developed to verify proper system functionality with functional testing throughout all anticipated ranges and modes of operation. The operational tests are designed
to challenge and demonstrate the system’s ability to operate in accordance with the approved system functional/configuration specifications.
7.4 Performance Qualification (PQ)
PQ protocol is developed to verify proper system functionality with observation of actual performance. The performance tests are designed to challenge and demonstrate the system’s ability to perform in accordance with the approved user specifications.
7.5 Qualification Discrepancy Report
Any discrepancy noted during the execution of qualification is documented. Whenever a discrepancy is closed or justified, thereafter only the system is considered ready for the next qualification.
7.6 Validation Report
On successful completion of all qualifications, validation report is prepared. It confirms that the Business Systems is working as intended.
7.7 Traceability Matrix
A Traceability matrix is created to show logical linking between approved functions (FS and URS as available) with various qualification documents and procedures for easy maneuverability of validation documentation.
8.0 PARTIAL LIST OF CLIENTS
Epitome has successfully completed various SAP and other business systems validation projects. A partial List of clients is given below
Sr No Client Location
List of SAP Validation Projects
1 M/s Alembic Limited Vadodara
2. M/s Claris Lifesciences Limited Ahmedabad
3 M/s Intas Pharma Limited Ahmedabad
4 M/s Lupin Limited Mumbai / Mandideep / Goa Tarapur
5. M/s Medley Pharmaceuticals Limited Mumbai, Daman, Jammu
6. M/s Microlabs Limited Banglore / Goa
7. M/s Nicholas Piramal India Limited Mumbai / Pithampur / Zahirabad / Ennore
8. M/s NATCO Pharma Limited Hyderabad
9. M/s Strides Arcolab Limited Banglore 10. M/s Torrent Pharmaceuticals Limited Ahmedabad
11. M/s Wockhardt Limited Aurangabad
List of Other ERP System Validation Projects
10. M/s Alkem Limited Mumbai / Daman
11. M/s Aurobindo Pharma Limited Hyderabad 12. M/s Dishman Pharmaceuticals &
Chemicals Limited
Ahmedabad
13. M/s EIPICO ( Oracle Process Management)
Egypt
14. M/s Global Pharmatech Private Limited Banglore 15. M/s J B Chemicals & Pharmaceuticals
Limited ( J D Edwards )
Mumbai / Panoli
16. M/s Jubilant Organosys Limited Noida / Nanjungud / Roorki
17. M/s Medreich Limited Banglore
18. M/s Oman Pharmaceutical Products Llc Oman 19. M/s Plethico Pharmaceutical Limited
J D Edwards Systems
Mumbai / Indore
20. M/s Promed Exports Private Limited Delhi, Solan 21. M/s Sidmak Laboratories (India) Limited Dehradun
9.0 REFERENCES
The publication listed below form part of any project being the reference documents. Each publication shall be the latest revision and addendum in effect on the date of this proposal shall be approved for execution unless noted otherwise.
Annexure 11 EU GMP regulation for Computerised System, Eudralex Volume 4 PIC/S guide Good practices for Process Systems in Regulated “GXP” Environments
GAMP 5 Good Automated Manufacturing Practices, Version 4, Guideline document for Automated Systems from International Society of Pharmaceutical Engineering GAMP guide Good Practice Guide – Testing of GxP systems
21 CFR 210 Code of Federal Regulations; Current Good Manufacturing Practicing Manufacturing, Processing, Packing, or Holding of Drugs
21 CFR 211 Code of Federal Regulations; Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR 11 Rule for Electronic Records and signatures
7132a.07 FDA’s Compliance Policy Guide; Process Drug Processing: Input/Output Checking
7132a.08 FDA’s Compliance Policy Guide; Process Drug Processing: Identification of Persons on batch Production and Control Records
7132a.11 FDA’s Compliance Policy Guide; Process Drug Processing: CGMP Applicability to Hardware and Software
7132a.12 FDA’s Compliance Policy Guide; Process Drug Processing: Vendor Responsibility
