Quality Management Systems
- Cloud or Paper Based Solutions
- Standard Operating Procedures
- GMP, GDP, Cosmetic, Medical Device ISO13485
- CAPA, Audits, Change Control
- Regular Quality Review Meetings
- Key Performance Indicators
- Tried and Tested Processes Adapted to Your Work Environment
We act as the Quality Assurance Department on behalf of a number of licence holders, ensuring they meet their requirements for document control and quality review.
Cloud based or paper based Standard Operating Procedures (SOPs) can be adapted to local requirements ensuring the current copy of any SOP is available at the point of use.
All our SOPs are bespoke to each client; we do not sell any ‘off the shelf’ systems. We draw on our experience across different pharmaceutical forms, product therapeutic areas, and GXP systems to ensure best practice is applied to each Quality Management System (QMS).
We recommend regular Quality Review Meetings with Key Performance Indicators to ensure full oversight of the QMS by all relevant parties – the licence holder, service providers, quality department, etc.
We run a risk-based SOP audit programme to ensure that every SOP is periodically reviewed for compliance and that the SOP is being used as intended.
We have established and proven systems for Corrective Action and Preventative Action (CAPA) system and Change Control that can be adapted for any situation.
We have a range of training methods, taking into account new starters, minor amendments, major revisions and periodic review.
We can provide a system to meet your specific quality requirements – GMP, GDP, Medical Device (ISO13485), Cosmetic – to ensure compliance with current regulations.
Contact us to discuss your requirements.