In the light of the ever increasing complexity of the regulatory environment, companies must rely on efficient and transparent quality systems. Every company functions in a different way and therefore, there is no off-the-shelf-fits-all solution. A quality system should be as simple as possible to ensure optimal acceptance and compliance.
The Archemin team
- provides advice, guidance and assistance in the development of Standard Operating Procedures
- develops and manages the implementation of CAPA plans
- prepares companies for and supports them during inspections
- performs audits, reviews or compiles contracts between various partners involved in the implementation of the quality system
- edits training manuals, provides and documents trainings
Good Distribution Practice
- Application for a wholesale and distribution license (local as well as international trade) for Medicinal Products (including narcotics, cold chain), Medical Devices, Active Pharmaceutical Ingredients
- Development and maintenance of the procedure handbook
- Training of warehouse personnel
- Preparation of and support during Audits by the National Health Authorities or Customers
- Warehouse and Transport Validation
- Temperature Mapping
Pharmacovigilance, Materiovigilance, Cosmetovigilance
- Development and maintenance of the procedure handbook
- Training
- Preparation of and support during Audits by the National Health Authorities
ISO 13485
- Gap analysis
- Development and maintenance of quality systems compliant with the most recent internationally recognised industrial standard ISO 13485:2003 for the medical device industry
- Setup of a document management system and programmation of the required software
- Validation of the process management system
- Training
- Preparation of and support during Audits by the Certification Bodies
Want to know more / require a quote ?
Send your request to qa-qc [at] archemin.eu