Quality Management

Our offer comprises gap analyses of established Quality Management systems, the generation and/or revision of Standard Operating Procedures (and further steered documents) as wel as a spot check Quality Assurance by independent audits.

Quality Management Systems

You want to submit your Standard Operating Procedures (SOPs) to a critical review or to establish a new Quality Management System? Based on our detailed experience in clinical operations and our work on several SOP systems we quickly identify potential gaps and consult you in the implementation of revisions and/or supplements.

Development or Revision of Standard Operating Procedures

Based on the results of our gap analysis or on you own analyses we support you in the revision and/or generation of SOPs, Working Instructions, templates and other steered dcuments in a competent way. Our writing style is pragmatic, our formulations precise, clear and understanfdabke.

Audits

You are in need of an independent Auditor who supports you within your Quality Management System? We can support you with the conduct of site audits, vendor qualification or by auditing your internal processes. The audits would be conducted either on the basis of our or your standards (SOP).