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Life Sciences Regulatory Compliance

 

Life Sciences Regulatory Compliance

The Invensys Operations Management team of dedicated industry experts is focused on providing you with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, IT). The Invensys offerings also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing you with an objective and authoritative view.

Invensys partners with you by developing a streamlined, cost effective and customized approach focused on results, targeting those areas that represent the highest business and compliance risk. Part of what makes the Invensys solution so effective is our ability to seamlessly blend in with your team. We guide you through project deployment and implementation of real solutions. From systems, to processes, to operations, Invensys provides a partner with a proven track record that will empower you to manage and improve your business performance.

Key Benefits

  • Greatly reduce or eliminate the risk of non-compliance and the related costs and other business impacts
  • Improve reliability and efficiency of your processes throughout their life cycle
  • Increase availability and production throughput for your manufacturing facilities

Key Capabilities

  • Vendor/platform independent regulatory compliance, validation, consulting and integration services
  • Risk management, including regulatory compliance gap assessments, interpretation of regulations and compliance assessment of systems from sensor to boardroom
  • Project management planning, management, implementation and execution
  • Training of personnel, management and staff
  • Science-based Quality by Design (QbD) and Process Analytical Technology (PAT) project support
  • Legacy equipment 21 CFR Part 11/EU cGMP Annex11 compliance
  • Biotech process simulation
Life Sciences Regulatory Compliance 
 

Related Success Stories

Raylo Gilead

Raylo Gilead implements Foxboro pH sensors which provide a robust design that helps improve process efficiency and batch yields while reducing equipment and maintenance costs.

Read the success story (pdf)

For Any Inquiries

General – Jonathon Thompson, +1-812-272-6302, jonathon.thompson@invensys.com or Life.Sciences@invensys.com  

US Regulatory Compliance - James Lysaght, +1-336-686-3764, James.Lysaght@invensys.com  

CAD Regulatory Compliance – Martin Boisvert, +1-514-591-7923, Martin.Boisvert@invensys.com