Approach
The ability to audit processes and documentary records is a core requirement of the FDA and all global pharmaceutical regulatory bodies. For SOLABS’ customers this is not a ‘nice-to-have’ extra-cost module. It is an integral part of the GxP compliant design. Audit can often highlight gaps in procedures as well as lack of compliance. SOLABS’ insistence on providing best practice knowledge and expertise as a standard part of its offering sets it apart from its competitors.
SOLABS works continually on improving its own internal practices for developing technical solutions deployed in GxP environments. Similar to our customers, we welcome being audited as part of a project deliverable. We have been audited by Merck & Co., Inveresk Research, CRCHUL, Invensys VT, amongst others.
Customers can have access to SOLABS’ Policies, methodologies, SDLC and standards document upon request.