Validation & Compliance

We screen business processes and procedures to comply with specific guidelines. This can also include compliance with specific inspections (FDA, MHRA, WHO GMP, etc.).

Agidens Life Sciences supports companies in the full preparation for audits and inspections by customers or by the government. For this, we analyse production processes and inspect work instructions and Standard Operating Procedures (SOPs) to examine them against the most recent regulations.

Together we can compile courses about the hows and whys of working under GxP. The differences between GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) are clearly explained. The course consists of a theoretical part and a workshop with examples from practice.

The current health economics guidelines require processes to be demonstrably controlled. Whether it is sterilization, disinfection, or thermally controlled storage or distribution, companies must guarantee that processes comply with the required conditions. Agidens Life Sciences offers bespoke solutions for this.

Cleanrooms, production facilities for pharmaceutical products, operation rooms, and LAF cabinets are subject to international legislation of the EU, FDA, and ISO 14644 Annex 1. This entails an obligation of validation and revalidation. Agidens Life Sciences provides advice and support from A to Z.

Global regulatory agencies focus on the entire pharmaceutical supply chain. Pharmaceutical manufacturers and distributers are obligated to guarantee that their products get to the patient, under the required temperature conditions. To demonstrate compliance, qualification and validation of essential components is a must.

Hospitals invest in professional sterilization departments with a focus on quality. After all, a controlled disinfection and sterilization process promotes patient safety. Agidens Life Sciences supports these departments with a wide range of validation and qualification services.

Flexible endoscopes offer many technical possibilities, making it increasingly complicated to clean and disinfect them. Mechanical cleaning is the recommended method, but requires a controlled process.

Agidens Life Sciences helps to check whether cleanrooms, production areas and operating rooms meet the international regulations and standards or GAMP. We develop a programme for the periodic control inspection or (re)qualification of cleanrooms.