Turnkey Projects
In Belgium and abroad, BiiON is taking charge of turnkey projects. Our missions are performed against the predefined cost and we stick to our commitments.
Added value of BiiON's services
1. Knowledge of business
- Understanding of the manufacturing process (SOPs)
- Account taken of constraints even if not expressed (Rules of good practice)
- Anticipating problems
- Experience feedback
2. An SOP oriented approach
- Analysis of operators' needs
- Identifying equipment constraints and limits
- Developing automated operations that can be integrated into the customer's operating procedures (SOP)
3. A Pharmaceutical industry focused methodology
- Integration of the QA approach at every stage of the project (V-model, Risk Based Approach as per ICH Q9 and ASTM E2500-07)
- Application development in accordance with GAMP5
- Commissioning and Qualification of systems including hardware and software (FAT/SAT/IQ/OQ)
