Whitepapers
ComplianceQuest Insights And Perspectives
Managing Your Medical Device Master Files and Records
In today’s age of Globalization and cut-throat competition, it has become competitive necessity fo...
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How to Keep it ‘Lean’ to Boost your Business
Implementing lean manufacturing programs to improve performance is the first step to enhancing produ...
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Control or Mess: Where’s My Document?
You are sitting in a room with an auditor who asks for the files about a customer complaint and CAPA...
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Why Supplier Quality Management Is Critical to a Manufacturer’s Success
Manufacturers need to take a much more demand-driven approach in integrating quality management and ...
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The Power of Cloud for Deploying Quality and Compliance Management and why it is so important
With the markets and manufacturers becoming more global and competitive, not only are the pressures ...
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Top 7 Principles to Create a Culture of Quality
Continuous Quality improvement is essential to running a lean and productive enterprise. To drive re...
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At the core of all effective enterprises
Enterprise systems have seen a boom in implementation since the 1990s. Available as big systems and ...
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Regulatory Auditing of Quality Systems of Medical Device Manufacturers
This document has been prepared by Study Group 4: Auditing which was convened by the Global Harmonis...
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ISO 13485 Medical Devices
Today’s competitive business environment has placed tremendous pressure on medical devices manufac...
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Architectural Overview
One of the most critical aspects of any company, and certainly one of the most concerning is product...
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Five Ideas for Making Supplier Quality Management a Competitive Advantage in Complex Manufacturing
For complex manufacturers the very definition of quality is predicated on how well they stay aligned...
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Medical Devices Guidance on the Control of Products and Services Obtained from Suppliers
This guidance document is intended for medical device manufacturers and it is expected that the read...
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Guidance on corrective action and preventive action and Related QMS processes
This guidance document is intended for medical device manufacturers and regulatory authorities. It i...
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Quality Management System for Medical Devices
Nonconformity Grading System for Regulatory Purposes and information Exchange
This document is int...
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Audit Language Requirements
In preparing this guidance, the study group was not aware of any regulations, which required written...
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Global Guidance for Adverse Event Reporting for Medical Devices
The objective of the adverse event reporting and subsequent evaluations is to improve protection of ...
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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers
This document has been prepared by Study Group 4: Auditing which was convened by the Global Harmonis...
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Regulatory Auditing Strategy
This document gives guidance to regulators and auditing organizations conducting audits of quality m...
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Path to Creating a Distinct Competitive Advantage
Manufacturers need to take a much more demand-driven approach to integrating quality management and ...
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How does FDA Train its Inspectors?
Per US FDA, Corrective and Preventive Action is defined as a sub-system to collect information, anal...
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Best Practices and FDA QSR Mandate
Establishing a corrective and preventive action (CAPA) system is a quality system requirement for Me...
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ISO 9000:2008 Requirements
Today’s competitive business environment has placed tremendous pressure on manufacturing companies...
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