Simple, Efficient & Effective Solutions for Regulated Small Businesses
Services
QPC Services has developed a significant service portfolio, providing everything from an ISO audit checklist to assisting you with FDA GMP development and improvement. Here are some key points about our services:
Strategic Planning: Strategic Planning is often ignored to the point where it becomes a significant barrier to continuous improvement and greater success. We can help you implement a strategic planning process that reaps benefits.
Internal Quality Audits: Never get behind on your internal audit schedule. We can perform internal audits for you, in accordance with ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing, or guidelines from GHTF Study Group 4 Auditing.
CE Mark Preparation: Need to acquire the CE mark for your medical device? We can lead the development or revision of your Quality Management System to meet the requirements of Medical Devices Directive, the Active Implantable Medical Devices Directive, or the In Vitro Diagnostic Medical Devices Directive.
Corrective and Preventive Action System Development: Let us help you develop a Corrective and Preventive Actions System (CAPA) designed to kill the problem dead!
Design Controls: Product development processes very significantly among different organizations, but the specific requirements for design controls must be met. We can help your organization develop or revise your design control process.
DocAssist: The DocAssist service is a semi-automated documentation management process designed by QPC Services specifically for small regulated businesses. Our partner/supplier Box.net has customized their Cloud Content Management tool specifically for QPC Services, and QPC Services has developed robust procedures to manage the documents through the document lifecycle. Redundant cloud back-up is provided by QPC Services through our back-up system provided by 3X Systems and technical support is provided by Data Doctor's.
Current Good Manufacturing Practice (cGMP) Development and Improvement: QPC Services offers this service to Medical Device Manufacturers, Pharmaceutical Manufacturers, and Supplement Manufacturers. We can help you assure compliance with FDA GMP regulations.
Lean Six Sigma ALTERNATIVE for Small Businesses: QPC Services' Lean Six Sigma ALTERNATIVE for Small businesses is a continuous improvement process design with cost containment in mind. Let us show you how our Lean Six Sigma ALTERNATIVE for Small Businesses can help you!
And more! Contact us to learn more about the services listed above, or the services too involved to describe with a brief description, such as Risk Management, Validation, 21 CFR Part 11, Quality Management System and FDA GMP Development and Improvement, Supplier Management Support, Premarket Notification Submission Development, ISO Audit Checklist Options, and Training Services.
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