Proven Validation Solutions
Ensure your pharma, biotech, and life sciences systems operate reliably and meet regulatory requirements.
Validation is a structured, evidence-based process that confirms systems, equipment, and processes consistently operate as intended—producing safe, reliable, and high-quality results. From early design and process development through commercial manufacturing, validation plays a critical role at every stage of the product life cycle.
RoviSys provides comprehensive validation services that align with current Good Manufacturing Practices (cGMP) across pharmaceutical, biotechnology, and life science industries. Our experienced engineers and validation specialists ensure your systems meet regulatory expectations while maintaining operational efficiency. By combining automation expertise with proven validation methodologies, we help clients reduce risk, document compliance, and achieve confidence in every batch, process, and facility.
Full Service Commissioning & Qualification Delivery
Validation requires expertise across engineering, quality, and regulatory disciplines. RoviSys combines industry knowledge and hands on experience to deliver compliant, end to end validation solutions.
Supporting Design and Requirements Definition
- URS – User Requirements Specification
- FS – Functional Specification
- DS – Design Specification
Commissioning & Qualification Planning
- Develop and manage C&Q Plan & Master Plan
Drafting & Executing Protocols
- DQ – Design Qualification
- IQ - Installation Qualification
- OQ - Operational Qualification
- PQ - Performance Qualification
- FAT/SAT – Factory/Site Acceptance Testing
Qualification summary reporting
Discrepancy/deviation management
Decommissioning
Consulting
- Data Integrity Assessments
- Security Risk Assessments
Validation Master Planning
A Validation Master Plan (VMP) serves as the foundation for all validation activities, providing a clear roadmap from planning through execution.
A strong foundation for all validation activities is a vital part of success. RoviSys empowers teams to define objectives, responsibilities, and standards that guide all validation activities.
We provide a clear roadmap from planning through execution. Each plan defines project objectives, methodologies, documentation standards, timelines, and roles so that stakeholders are aligned and systems meet regulatory and operational expectations.
- Regulatory Alignment: Validation activities are designed to fully comply with current regulatory standards and industry best practices.
- Risk Mitigation: Critical control points are identified early to minimize risks and prevent downstream quality issues.
- Operational Clarity: Clear procedures and documentation standards streamline execution and reduce variability.
- Cross-Disciplinary Collaboration: Validation goals and criteria are aligned across engineering, quality, and operations to ensure consistent outcomes.
Computerized System Validation (CSV)
As organizations transition to paperless operations and implement advanced software solutions, it’s essential to ensure these systems perform as intended.
Computer System Validation (CSV) confirms that critical software is reliable, secure, and fully compliant with FDA and industry regulations.
Maintain Data Integrity: Verify the accuracy, consistency, and reliability of electronic records throughout the system lifecycle.
Ensure System Security: Safeguard sensitive data against unauthorized access and cybersecurity threats.
Support Regulatory Compliance: Deliver clear, traceable documentation to simplify audits and demonstrate adherence to regulatory standards.
Enhance Operational Efficiency: Minimize manual effort, reduce errors, and streamline validated system performance.
Project Spotlight
Validated Controls Network Modernization
Design, implementation, and validation for a modern industrial controls network for a regulated pharmaceutical facility. The objective was to standardize infrastructure, reduce risk, and support compliant operations with minimal disruption.
Project Scope
• Standardized GMP ready network architecture
• Resilient core and distribution network design
• VMware infrastructure for validated systems
• Firewalls and segmentation for secure operations
• Validated Windows Active Directory environment
Validation and Delivery
• Design driven by approved functional specifications
• Factory Acceptance Testing prior to deployment
• Installation and Operational Qualification execution
• Audit ready validation documentation and traceability
Operational Continuity
• Integrated with existing business network
• Minimal impact to ongoing manufacturing
The result: A secure, scalable, and fully validated controls network that supports compliant operations today and future system growth.
DeltaV DCS Validation and Qualification
A Chicago based manufacturer partnered with RoviSys to validate a DeltaV Distributed Control System supporting critical process operations in a regulated pharmaceutical environment. The effort focused on confirming the system as installed as well as defining requirements, validation expectations, and audit standards.
Project scope
• Validation of DeltaV DCS control system
• Replication of production system in development environment
• System configuration documentation
• Support for manufacturing management and control
Validation and Execution
• Developed Design and Configuration Specification
• Installed and configured DeltaV DCS environment
• Executed Installation Qualification and Operational and Performance Qualification
• Managed traceability across nearly 100 URS and FRS requirements
Compliance Outcomes
• End to end requirements traceability
• Audit ready validation documentation
• Confirmed system fitness for regulated manufacturing use
The result: A fully validated DeltaV control system with clear documentation, strong traceability, and confidence in compliant operation of critical process systems.
Production Capacity Automation Upgrade
RoviSys expanded production capacity by automating new buffer preparation, storage, and critical utility systems. The project focused on reducing buffer wait times while ensuring reliable, compliant operation of expanded process infrastructure.
Project Scope
• Five new buffer prep and storage vessels
• New CIP skid and expanded RO distribution
• New AWFI distribution loop
Automation Delivery
• Control code development and testing
• Approximately 350 automated field instruments
• Foundation Fieldbus and DeviceNet integration
• New and modified control panels
Testing and Qualification
• CIP skid FAT using portable DeltaV system
• AWFI loop commissioning
• Installation and Operational Qualification
The result: A commissioned and qualified automation expansion that increased production capacity, reduced utility wait times, and supported reliable operation in a regulated manufacturing environment.
