Invensys Validation Technologies quality management practice offers regulatory services to assist our clients and efficiently solve quality issues related to automation, manufacturing IT solutions, equipment and facilities. The methodologies, documentation, implementation, and consulting services provided by Invensys Validation Technologies help our clients manage quality systems, and facilitate GMP compliance and validation.
We help companies develop and implement sustainable compliance programs and quality systems. Our unique Quality Management practice ensures the establishment of a quality system supported by the organization’s values, culture and business processes. Our approach to quality management starts with a risk assessment or gap analysis of existing regulatory compliance capabilities or processes and continues throughout the lifetime of the process or product.
Some of our services include:
- Risk assessment and prioritization of the client’s existing regulatory compliance capabilities
- Development of suitable tools, policies, and procedures to facilitate compliance
- Production of a Validation Master Plan
- Management of validation activities
- Management of 21 CFR Part 11 entire life-cycleof services from awareness and inventory to remediation
- Qualification of manufacturing IT networks.
- Ongoing monitoring and continuous improvement
- Training and instruction services on regulatory compliance issues, policies, and procedures
- Six Sigma processes
- Statistical process control
We specialize in listening to your needs and concerns. We start by asking specific questions that reflect our experience and help us to provide the right solution for your application.
"Quality is more than a goal - it is an integral part of our business. Through our people and methodologies, we provide high quality professional services to the life science industries. Together, as partners with our clients, we are committed to developing new and innovative ways to reduce costs and increase efficiencies, while continually maintaining the highest validation and quality standards."
Richard Fecteau
Vice President, Invensys Pharmaceutical Solutions
