Description
SECTION - I: SCOPE OF WORK AND RESPONSIBILITIESSCOPE
The scope shall include the validation of SAP Business One (Application): Version 9.2 on HANA and preparation of protocols and reports, the details of which are mentioned subsequently.
> Processes / Implement Modules
- Material Management
- Quality Management
- Sales & Distribution Management.
- Ware House Management
- Production Planning
- Finance
- HR
- Sales
> Site review, collection of process list inventory
A collection of process inventory list to be done for the overview of the processes being used in the SAP Business One (Application): Version 9.2.
> Develop Validation Master Plan
A validation master plan must be developed to describe the objectives, scope, approach and responsibilities for the SAP Business One (Application): Version 9.2 validation. The validation master plan shall be approved before any of the protocols are approved.
> Document User Requirements Specifications
A user requirements document must be developed as part of this validation effort. This version-controlled document will formally specify PHARMAX’s intended uses for the various function of SAP Business One (Application): Version 9.2 systems.
> Risk Assessment I (Initial Risk Assessment)
SAP functions/Module corresponding to all business processes pertaining to PHARMAX Pharmaceuticals must be listed out in a document called ‘Business Process Master List’ (BPML).
GxP relevant questionnaire to be executed for each of the processes lay down in the respective module BPML, similar process step which comes across multiple BPML processes shall be performed once.
> Risk Assessment II
Having determined in Risk Assessment-I that a particular function is GxP relevant, the assessment shall proceed to carry out their detailed analysis to identify the effect of failure of process/data/operations associated with the said function i.e. identifying all risk scenarios.
Various risks related to GMP to operate the SAP Business One (Application): Version 9.2 systems must be identified. All risk identified during assessment process must be challenged during the operation qualification.
> Installation Qualification (IQ)
Prepare installation qualification protocols for SAP Business One (Application): Version 9.2 server system and carry out challenge testing for recommended installation practices by the manufacturer / developer.
Prepare a discrepancy / deviation report
> IT Infrastructure Qualification / Network Qualification.
IT Infrastructure or Network supporting the SAP Business One (Application): Version 9.2 Functions must be qualified as a 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
> SOPs for IT
Content to all required IT SOPs must be provided and also help the PHARMAX to convert them to the IT SOPs to support SAP Business One (Application): Version 9.2.
> Operational Qualification (OQ)
Prepare operational qualification protocols for each sub systems and carry out challenge testing for systems functional and operational programs. Operational Qualification will be carried out in Simulation or test server.
> Data Migration
There is no legacy system available; hence this part is not applicable
> Performance Qualification (PQ)
For the systems involving complex control loops performance qualification to be carried out for the systems’ response and stability to process condition variations and load changes.
Performance Qualification must be carried out in Live Database.
> Validation Summary Report & Traceability Matrix
Prepare Validation Summary Report to provide for summary of test result and qualification status at the end of protocol execution. The Traceability Matrix must establish the linkage between URS / FS to Risk and Challenge Testing.
> Documentation
• User Requirement Specifications / Functional Specifications
• Validation Master Plan.
• Risk Assessment Report.
• Installation Qualification Protocol and Report.
• Infrastructure Qualification Protocol and Report (Network Qualification)
• Operation Qualification Protocol Report.
• Performance Qualification Protocol and Report.
• Deviation Reports.
• Qualification Summary Report with Traceability Matrix
• Preparation of IT SOPs for SAP Business One (Application): Version 9.2
> Periodic Review & Support
• Hardware / software change control
• Software version control and patch management
• Application up-grades
• Revalidation