Invensys Validation Technologies is a recognized global leader in providing computer systems validation and regulatory compliance services for the pharmaceutical, biotechnology and healthcare industries. Our work with computer and automated systems, including compliance with the U.S. FDA’s 21 CFR Part 11, is well known throughout the industry. Invensys Validation Technologies’ resources encompass a broad range of compliance expertise with most major manufacturers.
Invensys Validation Technologiess has a dedicated group of pharmaceutical engineers, consultants and specialists focused on this industry, regulations and new technology tools. Our services include a full range of products, automated tools, validation services (VTI) and procedures to help enable compliance to 21 CFR part 11 and the EU Annex Part 11. We leverage our expertise to provide systems, tools, policies and procedures for compliance.
Invensys solutions for life science companies can helps you achieve and maintain a competitive advantage by:
- Developing state-of-the-art solutions for compliance
- Developing a prioritized list of specific improvements that need to be implemented
- Identifying specific actions necessary to become compliant
- Automating software validation process
- Implementing automated tools for validation and validation management
- Meeting validation schedules and critical path
- Minimizing the effort required for on-going regulatory compliance
- Improving operational efficiency
Invensys Validation Technologies has validation expertise and experience with all types of computer systems across the enterprise, including manufacturing, packaging systems, laboratory systems, clinical trial systems, and information technology/ business systems. Our expertise includes the development of global standards and methodologies across the supply chain. Invensys Validation Technologies™ can assist you in defining and implementing your requirements involving computer systems by providing the following services:
- Determination and prioritization of your computer system validation requirements (risk analysis)
- System validation master planning
- Definition of system design requirements and specifications (user and functional)
- Development of policies and procedures (information systems, business systems, supply chain, manufacturing, laboratory, etc.)
- Documentation and testing of systems (test plans, test protocols, scripts, execution, and reports)
- Computer validation training
- Software vendor audits
- System implementation and project management
- Prospective and legacy system validation
- Electronic record/electronic signature compliance (21 CFR Part 11)
Invensys Validation Technologies provides expertise and assistance in computer system validation by applying proven, efficient solutions based on current industry standards.
Through the use of risk analysis tools, we can define the scope and focus of your computer system validation effort. Defining and justifying the end point of each computer system validation project is key to managing the scope and thereby the project plan of computer system validation. Invensys has broad experience in system validation across the supply chain.
- Our enterprise expertise includes tremendous knowledge and experience with all typesofcomputersystems and networks:
- Information Technology/ Global Business Systems (Link to ERP Practice section 5.5.1)
- Manufacturing, Automation and Control Systems (Link section 5.5.3)
- Facilities and data management systems (link to facilities Section 5.6)
- Packaging and Laboratory Systems, Equipment and Instruments (Link to Laboratory Systems, Equipment and Instruments Section 5.6)
Invensys Validation Technologies has the experience, expertise and corporate commitment to deliver cost-effective and compliant solutions.
