Introducing CIMQUEST, Inc.
 
CimQuest has become a recognized leader in providing a variety of compliance services to the Life Sciences Industry. As a full-service company we offer consulting services related to Technology and Compliance including Risk Management, Computer Systems Validation, Electronic Records & Electronic Signatures, Auditing and Training in the Quality Assurance, Laboratory, IT/IM, Business Processes, Manufacturing, Operations and R&D environments.
 
A privately held, career based company incorporated in 1992, CimQuest, along with our Global Alliance partners, provides services worldwide and has successfully executed projects throughout the US, Canada, Puerto Rico, Switzerland, France, Ireland, the UK, Spain and Mexico.
 
Our knowledge of current regulatory expectations and international standards, combined with our technology expertise, enable us to understand the challenges and issues faced by pharmaceutical, biotech and medical device companies. We help our clients achieve their business goals and objectives while maintaining regulatory compliance and a state of control across all operational areas within the enterprise.
 
With a depth of expertise in all facts of the system development and implementation life cycle we are able to assist our clients to reach their goal of efficient and economic system implementation and validation. This includes Research & Development, Clinical Trials, and Quality Assurance, Laboratory, IT/IM, Operations, Manufacturing and Distribution. CimQuest will evaluate and access your current business operations then provide solutions to streamline processes and reduce regulatory exposure. The application and implementation of recommended standard solutions will increase harmonization and management of critical cross-functional business systems. Thus, mitigating the risk of non-compliance, reducing costs, increasing profitability, and helping to achieve Operational Excellence.
 
CimQuest has been working with regulated industries for nearly two decades, giving us a unique perspective and an understanding of what it takes for any size company to be in compliance with FDA and other governmental regulatory agencies. We have demonstrated expertise in the following areas:
 
• Mock FDA Inspections
• Risk Based Approaches (including Assessments, Validation and Management)
• Systems Selection, Configuration & Implementation Assistance
• Network Infrastructure / Servers / Component / Qualification
• Computer Systems Validation
• Electronic Records / Electronic Signatures Compliance
• Laboratory Commissioning
• Lab Instrument Qualification
• Manufacturing Equipment Qualification
• Supplier Audits (Manufacturing, CRO, Software Supplier)
• Training