Software for the pharmaceutical industry
The acadon solution for the pharmaceutical industry is a powerful and fully integrated company software for medium-sized and large-scale enterprises with multiple locations, as well as for internationally oriented organisations. This solution simplifies and standardises business processes, creates transparency throughout the entire company and provides a sound basis for decision-making.
acadon AG organised an independent, external supplier audit on the basis of GAMP 5 as well as on the relevant EU GMP guidelines.
The aim of the audit was to determine audit-readiness for certified suppliers in the highly regulated industry. The following areas were audited:
- Quality management
- System Development Life Cycle (SDLC)
- Development and programming standards
- System documentation
- Testing
- Configuration management
- Software security
- Archiving
- Customer support
- Training of employees
The role-based design enables employees to organise, prioritise and access tasks and information in a single window. Employees quickly learn to use the tried and tested Office user interface without the need for extensive training measures.
Core functions:
- Transfer and blending
- Formulations
- Bundles
- Management of safety data and accident leaflets
- Specifications
- Analysis certificates
- Multi-dimensional batch handling
- End user declarations/supplier declarations
- Ordinance on hazardous goods
- Delivery memos
- REACh trade and import/REACh production
- GHS compliance
- Sample deliveries
- Returns to suppliers
- Customer profiles and purchasing patterns
- Management of sales potential
- Process-oriented manufacturing and capacity planning
- Management of testing equipment in production
- Customs warehouse processing and customs/ATLAS integration
- Integration of DR software
- Validation