Quality Management
Continuous improvement is not a tool or technique as such - it's more a 'way of life' - and it has to be set in the context of 'the quality movement'. idCO recognizes its importance and the role of quality management, auditing, compliance and rescue missions for the successful development of your product.
Firstly, we can help you set up your Quality Management System (QMS).
- Develop a comprehensive QMS for your organization, including manuals, policies, standard operating procedures (SOPs), work instructions, forms
- Write the above controlled documents, allowing for geographical & regulatory differences and taking all stakeholders' opinions & concerns into account
- Establish a mechanism linking personnel training requirements to QMS documents
- Depict processes graphically
Secondly, we can evaluate, or audit, your existing QMS, its documents and the sites where clinical trial work is being carried out for compliance with Good Clinical Practice and/or Good Laboratory Practice (GCP / GLP) standards.
Thirdly, we can help you with compliance and rescue missions:
- Evaluation and inspection of underperforming or non-compliant sites
- Evaluation and inspection of underperforming outsourced service providers
- Compliance advice
- Corrective action plans and implementation
- Success metrics