If you are a quality manager, make it your life's ambition to persuade major operational stakeholders in your company to accept joint ownership of quality & compliance strategies and concepts. Because Quality Management and Assurance is so much more efficient when everybody is singing from the same sheet music.

We can help you in setting up efficient and lean Quality Management concepts from the same sheet music for:

• Document Management and Control
• Records, Templates, and Workflow Management
• Change Control Management
• Corrective and preventive actions (CAPA), Investigations
• OOS* and OOT** Management; Investigating Out-of-Specification; full scale and root cause analysis
• Audit Management (internal, external, self inspections)
• Vendor Audit Management
• Deviation Management
• Training Management
• Compliant Management
• Process Mapping
• Compliance standards to ICH Q9 and Q10, ISO 13485, ISO 9001:2008 etc.

At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more proactive and risk-based approach to quality management and assurance backed by proven expertise and IT systems from our partners.

We focus on value-added operational processes to achieve regulatory compliance and inspection readiness.

Discover with us the easiest way to comply with regulations. Start your Live Proposal Request right now.

* Out of specification (OOS) results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer.

** Out of trend (OOT) results includes all suspect results that fall outside the trend specifications or acceptance criteria for the trends established in new drug applications, official compendia, or by the manufacturer.