Quality & Validation

Validation

Our cost-effective range of validation, qualification, and testing solutions help you improve your systems and processes to reduce variability, mitigate the risk of non-compliance and ensure reliability.

Whatever sector you operate in, our experienced subject matter experts use proven processes and industry best practices to help you comply with all necessary regulations and drive value across your supply chain.

Computer Systems Validation (CSV)

Enterprise Resource Planning (ERP)
Electronic Product Code Information Service (EPCIS)
Quality Management Systems (QMS)
Electronic Document Management Systems (EDMS)
Corrective Action and Preventive Action (CAPA)
Learning Management Systems (LMS)
Manufacturing Execution Systems (MES)
Laboratory Information Management Systems (LIMS)
IT infrastructure and security
Data integrity assessment and validation

Process and Method validation
Sterilization validation
Cleaning validation
Facilities and Utilities qualification
Temperature and environmental monitoring
Equipment qualification
Factory and site acceptance testing
Risk assessment and mitigation
Validation and compliance training

Quality Management

We offer a range of quality management services to ensure your systems are optimized and compliant from the very beginning of your journey towards commercialization. This helps mitigate your risk of experiencing costly and/or time-consuming non-compliant situations when going to market, while at the same time driving process reliability and repeatability. From Strategy through Sustainability, our subject matter experts can also provide ongoing guidance and support around how your systems should be validated and maintained in order to comply with new or evolving legislation.

Quality Health Check
Quailty Systems Implementation Plan
Compliance Assessment and Auditing
Gap Analysis
Inspection Readiness
Audit Support
Remediation Plan and Execution