Process manufacturers face the complex challenge of complying with worldwide country-specific regulations.
Since many firms wish to take advantage of the large US pharmaceutical market for products and devices, they must comply with US FDA regulations. However, most companies are also selling products to the growing worldwide pharmaceutical markets, and must also comply with regulations from other countries, for example specific regulations from the European Union (EU), United Kingdom, Canada, Japan, Australia and ICH.
Invensys offers software. technologiesand peoplethat support compliance and also regulatory consulting and validation services that help meet the most stringent regulations, country by country. Compliance requires a combination of features, tools, people, policies and procedures as well as validation of the process, systems and methodologies.
