60%Less test preparationCase Study · Biotechnology
Global Specialty Pharma Company Automates Quality and Validation with ValidationMaster eQMS™
A U.K.-based specialty pharma company growing through acquisition replaced paper-based quality, training, and validation processes with ValidationMaster eQMS™, ValidationMaster IQ™, and the ValidationMaster® platform.
- 65% Less validation test time
- ERP & eQMS Program
- Pharmaceutical Industry
The Challenge
Manual, paper-based quality, training, and validation processes across more than 60 enterprise technologies.
The Solution
ValidationMaster eQMS™, ValidationMaster IQ™, the ValidationMaster® platform, CloudMaster 365™ for Oracle e-Business, and ValidationPro℠ services.
The Result
A validated ERP system on time and within budget, 100% visibility into quality processes, and 65% less validation test time.
The Challenge
The company was standardizing its supply chain processes to ensure enterprise technology harmonization, interoperability, and compliance, and it selected Oracle e-Business as its ERP system.
Its quality processes were manual and paper-based. It had no controlled system for managing documents, and no automation for tracking customer complaints or managing vendors, CAPA, audits, and other quality processes. Training and validation were also managed on paper. With over 60 enterprise technologies in place, keeping up with change was a constant challenge. The company needed to standardize, harmonize, and automate its quality and validation processes.
The Solution
OnShore Technology Group delivered an integrated, three-part solution built on the ValidationMaster® platform and its Microsoft foundation, with custom workflows created for the client’s internal processes:
- ValidationMaster eQMS™: A configurable SharePoint-based quality system that manages and automates the company’s internal quality program.
- ValidationMaster® platform: Automated testing and full validation lifecycle project management, supported by CloudMaster 365™ requirements and starter IQ/OQ/PQ test scripts for Oracle e-Business.
- ValidationMaster IQ™: Compliant tracking and management of enterprise training and competency.
ValidationPro℠ Enterprise Validation Delivery Services™ prepared all validation deliverables and managed the project from end to end, freeing internal resources for more strategic work. OnShore Technology Group also helped develop the Standard Operating Procedures that govern the ERP system and its validation processes.
The Results
- On time and within budget: The client launched its validated ERP system as planned, with ValidationMaster® implemented out of the box at no additional charge.
- 100% visibility into quality processes: ValidationMaster eQMS™ automated quality processes and provides enterprise dashboards.
- 65% less validation test time: A reusable test script library supports ongoing maintenance of the validated state.
- One source of truth: ValidationMaster® now serves as the single source of truth for validation across the enterprise.
Solutions Used
Customer success
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