Production systems for the pharmaceutical and food industries have to comply with ever-stricter regulations, quality standards and production guidelines (like ISO and GxP). Organisations often struggle to guarantee that their products meet all requirements.
Many quality professionals in the industry are experiencing the pressure:
- Do we comply with all GxP and ISO 13485 demands?
- Can’t we make our quality control systems more efficiënt without compromising on performance?
- Should we validate all IT systems? Which modules of our ERP-system are critical for GXP compliance?
- How can we improve the integration of our quality control system with our production processes?
- How can we lower our total compliance costs?
We can help
We perform a thorough on site risk assessment of your ISO and GXP compliancy. The result is a detailed gap analysis and a CAPA list with critical actions. Based on the urgency of the actions, we prioritize the actions in a capability maturity plan.
The Quick Scan comprises the following activities: