Quality Management Systems
GCP QMS support
Kosieradzki.com supports:
- Sponsors,
- CROs,
- Phase 1 / Early development Units and
- Clinical sites
in the development or improvement of
Quality Management Systems (QMS) by using
- Sponsors,
- CROs,
- Phase 1 / Early development Units and
- Clinical sites
in the development or improvement of
Quality Management Systems (QMS) by using
Training on how to develop and write
Standard Operating Procedure (SOP),Independent QMS gap analysis,
QMS audit,
SOPs review and revision,
We use process mapping, mind-mapping and process workshops for building the framework of the procedures and structure of the QMS.
GCLP
QMS development of Phase 1 units might be supported by an implementation
of Good Clinical Laboratory Practice - GCLP accreditation program
It consists of the following steps:
Development of the GCLP-Strategy – requirements for laboratory processes
GAP analysis of the current status and GCLP-Strategy
Agreement on the scope of work. (Update or implementation of the SOPs, training).
Implementation of the required changes
Confirmation of the GCLP-Strategy Implementation – quality assurance audit
Certification
