Ensuring regulatory compliance is the key to success in the life science industry.
Manufacturers of pharmaceutical and medical products must adhere to a range of stringent compliance demands to assure product safety and quality as well address corporate governance, risk and various industry-specific regulatory issues. These issues can affect all areas of the organisation and may also vary from region to region.
Endress+Hauser offers a range of measurement solutions and value-add services to deliver compliant projects for the life science industry in any country.
Based on our experience to conduct automation projects and project management according to the GAMP5 guidelines, we have evolved our expertise in field network engineering and automation for:
- clean room monitoring
- distillation columns
- energy monitoring and management
- water for injectables
- many others skids applications from upstream to downstream processes
Simple integration of measuring instruments into control and visualisation systems is a major benefit for users. Additionally the users have the freedom to apply any bus technology. Whilst this ability is regionalised, it is further supported and continuously improved by our dedicated Centres of Competence for the life sciences industry, which are established in Reinach (Switzerland) and in Greenwood (U.S.A.).
Life cycle costs have become increasingly important across all industrial processes. This is particularly the case in the life science industry where there are requirements for relevant information and documentation according to the qualification needs and User Requirement Specifications (URS).
A suite of software solutions that cover each phase of the life cycle supports these requirements:
- Applicator selection, design and calculation,
- Fieldcare - configuration, through to asset management Installed Based Audit (IBA) risk evaluation
- W @ M portal- hosts the linking of afore mentioned tools
These solutions contribute to saving time and money and minimising problems while allowing the highest level of life cycle assets management.
Highly accurate metrology
Highly accurate and repeatable critical process measurements are a crucial aspect in Life science and a proud competency for Endress+Hauser. To ensure this, all production facilities calibrate using the same measurement standards, methodologies and leading production equipment.
Open and web-based information
Via web-based, web-enabled and non-proprietary technologies, we streamline data to provide customer-relevant information only. The result is more consistent drug manufacturing quality and increased profitability of the licensed production.