Life Sciences Regulatory Compliance Services

Wonderware team of dedicated industry experts is focused on providing companies 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, Information Technology). Wonderware offerings also include quality audits and assessments.
Our full range of services and solutions are vendor and platform independent, providing organizations with an objective and authoritative view.

 

 

Regulatory Compliance: The Wonderware Difference

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

Key Capabilities

  • Vendor and 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 and EU cGMP Annex 11 compliance
  • Biotech process simulation

Key Benefits

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