The international legislation in GxP constantly changes. Thanks to advanced training programs our validation and compliance engineers have become experts in current FDA and EU regulations and directives. Agidens supports companies in the full preparation for audits and inspections by customers or by the government. Our unique combination of automation solutions and validation & qualification support makes us an ideal partner for the most challenging projects in Life Sciences industries.
Not only do we analyse your production processes, we also inspect your work instructions and Standard Operating Procedures (SOPs) to examine them against the most recent regulations. Our broad experience in the pharmaceutical and biotechnological sectors ensures that within a few days you have a clear insight as to whether or not you comply with the current regulations.
We conclude such brief studies with a GxP Compliance Assessment Report. It contains a full overview of your activities, showing the measure to which you meet the guidelines and a list of recommendations for rectifying any shortcomings.
- General GMP (Good Manufacturing Practices)
- Standard Operating Procedures (SOP)
- Qualification and verification approach
- Process validation
- Thermal validation
- Packaging and distribution
- Computer System Validation (CSV)
- HVAC and cleanrooms
- Quality systems
How can we help?
Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.