SAP ERP Validation
We at RADIANT CONTROL SYSTEMS have been proud partners of many companies in the life sciences industry (pharmaceutical and medical technology). Our clients are top pharmaceutical, Biotech and Medical devices companies and we have helped them with the implementation and further development of their SAP systems. We specialize in SAP/ERP validation protocols such as Microsoft Dynamics, SAP, and Oracle (JREdwards and e-business suite).
Thanks to our years of experience, we have crafted SAP validation processes that are cost-effective, risk-based and scalable. We are an SAP validation company that helps you with the entire lifecycle, starting from implementation to decommissioning and data archiving. It includes SOPs, templates, training materials and tools for software validation.
- Evaluating and validating new system requirements: This helps you expand your R&D capabilities so that you can meet advanced scientific requirements.
- Prospective SAP validation: To validate SAP systems and their business processes during implementation.
- Retrospective validation: To ensure compliance of ERP protocol when there’s a change in usage pattern or configuration update requirements.
- IT Infrastructure Qualification: We make sure that your IT infrastructure components are validated and qualified in line with the audit.
- Turnkey implementation of SAP Validation Remediation projects for audit readiness.
- SAP software validation methodology: We create SAP validation frameworks with work instructions for SAP validation. Once done, we implement ourselves and train your staff.
- Revalidation services: To cater to major system/process changes in mergers, divestiture, acquisition, etc.
- Ongoing systemic validation: To continuously perform upgrades to maintain standards at par with the latest industry requirements, integrating all changes in the existing ERP Life Cycle.
The SAP/ERP validation process consists of many steps. It starts with defining validation plans and ends with auditing suppliers and service providers. Here’s what the process looks like:
- Concept of validation strategy, plan and report
- Creation / Review of Life Cycle Documents
- Requirement management and process mapping
- Project, Training & Test Management
- Data migration and data verification strategies
- Change Management
- Periodic Review
- Supplier management
- Audits of suppliers and service providers
Compliance with GAMP 5 Protocol
We make sure that our ERP validation is in compliance with the GAMP 5 protocol of the SAP ERP solution.
Decades of Expertise
Thanks to our decades of experience, we have developed potent methods for SAP implementation and validation.
End-to-End SAP/ERP Solution
We provide you with end-to-end validation of SAP systems including detailed documentation, implementation, testing and training.