QUALITY MANAGEMENT SYSTEMS

Services for the Regulated Environment

Federally regulated industries represent a significant sector of the current GCI client base, including Food, Pharmaceutical and Cosmetic manufacturers. Many of our clients are now faced with more stringent enforcement of regulations while manufacturing equipment and control systems continue to become increasingly complex.

GCI recognizes the challenges facing our regulated clients and takes a proactive role in Process Validation, Computer-Related Systems Validation, and Equipment Qualification through our Quality Management Systems and Services.

As we design, construct and commission our products, we incorporate processes, procedures and documentation essential to the qualification of our systems.By working directly with our client�s Quality personnel, we are able to proactively identify the requirements, deliverables and acceptance criteria for system validation. This allows our clients to leverage the quality activities we devote to constructing their systems, thus eliminating duplicate effort, costly delays and rework.

GCI Quality Systems Services is a flexible offering to enable the client to choose the level of service required for a particular project. We offer everything from content-specific products to turnkey qualification packages. Our Subject Matter Experts can offer guidance and clarification or can be an extra pair of hands for protocol development and execution.

As a member of ISPE and CSIA, our quality methodology is based on accepted standards such as the ISPE Baseline Guide on Commissioning and Qualification and the Good Automated Manufacturing Process GAMP 4 Guide.

QMS Methodology

QMS Documentation