SeerPharma has been engaged by a major multinational manufacturer to provide guidance and support on Computer System Validation (CSV) for a digital migration project. Based in Singapore this company has a global client base of leading companies in the Life Sciences and Medical industry. The client is heavily involved in the design and manufacture of equipment used in areas such as point-of-care, imaging, diagnostics, and pharmaceutical drug research.
The manufacturer currently uses SAP (ECC6) to support the management of its inventory, logistics and quality management processes. With support for ECC6 ceasing soon, the client will be migrating to SAP S/4 HANA. Being a key computerised system that is involved in the manufacture of regulated products, our customer must demonstrate that the use of SAP remains in a validated state during the transition to S/4 HANA.
SeerPharma has been engaged to be part of the project team, which will include the client’s SAP implementation partner. We will provide validation and consulting services to the project by following the FDA Computer Software Assurance (CSA) framework.
SeerPharma will use a proven methodology for the validation of SAP where the steps follow the CSA model for a pragmatic approach with traceability. Where the implementation partner is contracted to provide deliverables which are required as part of the CSA validation process, SeerPharma will provide validation/QA input and review the implementation partner’s deliverables.
SeerPharma activities and basic sequence for the validation of the system will be:
- Prepare a Computer Software Assurance SOP for the client which will be used to guide the validation activities for the project.
- Provide validation/QA input and review the User Requirements Specification (URS) for the system.
- Provide training in the CSV/CSA approach to all project team members early in the project to ensure everyone is aware of the regulatory importance of the validation process.
- Perform a ‘discovery’ workshop to fully assess the project approach from the implementation partner, regulatory and functional risk assessment on SAP ‘module’ use to assess the scope and level of validation required. This will rely on inputs from the implementation partner and URS from the client. The outputs will form the content of the Validation Plan.
- Provide validation/QA input and review to the client’s IT/IS governance processes and determine those that need updating due to the SAP cloud infrastructure being used. This will allow for appropriate reference to these from the SAP Validation Plan.
- Develop a system Validation Plan (VP) including deliverables, roles, responsibilities and validation timelines.
- Lean on relevant Technical Specifications from the SAP implementation Partner describing any customisations or configuration of critical setup data. SeerPharma will provide validation/QA input and review with the intention of these as Design/Configuration documents (including user security access/menus/customised queries and reports/critical parameters).
- Provide validation/QA support as requested to any Quality critical unit/system/integration testing performed by the system implementation partner. SeerPharma will provide validation/QA input and review to the SIT report.
- Review the SAP support agreement and write an IQ Summary Report for the infrastructure and SAP application.
- Provide training in the CSV/CSA approach and the importance of good testing and test documentation practices to the business users who will be involved in User Acceptance Testing, to ensure that testing documentation meets regulatory requirements.
- Work together with the implementation partner to prepare Quality critical Test Plans and Test Cases for User Acceptance Testing (challenging the URS) to be executed by the client. SeerPharma’s responsibility is to ensure Quality critical UAT documentation meets regulatory requirements and provides appropriate objective evidence based on the risk assessment. Non-Quality critical UAT Test Plans and Test Cases will be prepared solely by the implementation partner, while Quality critical UAT Test Plans and Test Cases will be prepared by the implementation partner in conjunction with SeerPharma to avoid duplication. SeerPharma to provide validation/QA input and review to User Acceptance Testing reports. Note that the following types of testing are to be considered:
- User Profile tests
- There will be several different user profiles that affect the operation of SAP. Some profiles will not allow features of the product to be used. Selected user profiles with restricted access (not all) will be tested, again with a focus on GMP critical records.
- Workflow tests
- These tests are designed to ensure that discrete work areas test their critical transactions and be assured that they are fully functional before the whole workflow of multiple transactions. Workflow tests will be run to validate the business cycles.
- User Profile tests
- Develop a Requirements Traceability Matrix (RTM). This will demonstrate requirements tracked to design/configuration through to testing.
- Prepare a Validation Summary Report, detailing the results and conclusions of the project.
- Provide ad-hoc Validation/QA input to the project as required, including participation in Stage Gate decision-making meetings, review of client activities, responding to validation support requests or queries, and review of implementation partner activities or deliverables.
- Attend status meetings and ensure ongoing communication with the client and Implementation Partner via calls, emails and project tracking.
- Prepare a Decommissioning Plan, provide Decommissioning Data Integrity Tests and oversight, and prepare a Decommissioning Report.
The project will run through 2026 and will require our team to provide support in-person and remotely over that period.
SeerPharma has a wealth of experience in assisting regulated clients in the Pharmaceutical and Medical Device industry to ensure their key IT business systems and applications are compliant to FDA, EU and international requirements.
Contact us should you wish to learn more about how SeerPharma can provide CSV support to your organisation.
