Commissioning & Qualification
Achieving compliance with the rigorous GxP guidelines in the life sciences industry requires a deep understanding of processes, installations, and instruments throughout their life cycle. A proficient partner can help address challenges and ensure compliance with confidence.
In addition to years of practical experience, Agidens has the best knowledge of current industry practices and the latest developments in the area of GxP.
OUR APPROACH TO COMMISSIONING & QUALIFICATION
Our comprehensive approach encompasses all stages of the life cycle, ensuring that your equipment, cleanroom, computer systems, and more are fully prepared and compliant. We analyze, test, and validate processes, spaces, and labs, relying on years of practical experience and knowledge of industry best practices and the latest GxP developments.
- Commissioning and qualification plan: developing the C&Q strategy, plan of approach, methodology, and ready-to-use templates
- Pre-inspection checklists
- Functional performance tests
- Design reports
- Training for operation and maintenance of systems
All our documents comply with good documentation practices, enabling them to be used for qualification purposes (leveraging).
OPERATIONS SUPPORT & RETIREMENT
During the operation of installations, various processes and equipment may undergo modifications. We provide the necessary know-how for related quality systems and processes such as change control, CAPA, and deviation management.
Upon retirement of a GxP installation, we offer decommissioning and data migration support, ensuring a smooth transition and continued compliance.
COMPREHENSIVE QUALIFICATION OF INSTALLATIONS & INSTRUMENTS
In compliance with GAMP5© and/or ASTM E2500, our validation engineers are experts in the qualification and verification of installations and instruments, including:
- Utility systems
- Filling lines
- Depyrogenation tunnels
- Packing machines & Packing lines
- Washing machines
- Manufacturing and holding tanks
- CIP/SIP systems
- Granulation and mixing equipment
- Tableting and capsuling machines
- Lab Equipment Qualification
- Cleanrooms and HVAC
- Production systems such as (bio)reactors, dryers, filters, process control systems (PLC, PCS, etc.)
TAKE YOUR COMMISSIONING & QUALIFICATION TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
Process & Cleaning Validation
Process validation guarantees a focus on patient safety, product quality, and data integrity for both producers and consumers. Moreover, Agidens offers guidance and assistance for cleaning activities in laboratory and pharmaceutical production settings.
Analytical Instrument Qualification
The reliability of equipment, accuracy and the integrity of analysis results are of great importance. We support you with our permanent endeavor to comply with all regulations by making use of solution-oriented, multidisciplinary consultants.
As the Life Sciences industry evolves, mastering temperature control and compliance is non-negotiable. Uncover the indispensable role of Thermal Validation services in providing tailored solutions for sterilization and controlled storage processes.
Computer System Validation
CSV provides producers with documented proof that the computerized/automated system performs consistently and in compliance with all regulations involved.