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Compliance and Technology: How to meet changing FDA expectations
The book explores how the use of technology in the past decade has helped both regulated companies and regulatory agencies in easing the pains and costs of compliance.
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9 Pitfalls to Avoid During the Document Control Process
In a regulated environment, the document control process can either be an obstacle course replete with pitfalls, or it can be a smooth ride to a successful product launch.
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Spark Medical Marijuana
As a medical marijuana startup or small business you have big ambitions and little margin for error. A digital QMS technology is a driver for getting products ready to go and on the market sooner.
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Get Ready to be in the Market Faster with MasterControl Spark
In industries like medical device, biotech and medical marijuana, the margin between success and failure is thin. Master compliance early on to get ahead of your competition.
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Top 5 Trends for Nutraceuticals in 2018
Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health.
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Top 5 Trends in the Pharmaceutical Industry in 2018
This white paper takes an in-depth look at trends in the pharmaceutical industry that are anticipated to make a significant impact on the sector in 2018.
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Advancing Beyond CAPA Using Innovation for Growth and Improvement
Creating solutions when traditional problem solving and investigations may not work—or when an improvement or breakthrough is needed beyond a traditional CAPA approach—may be more art than science.
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Debunking 5 Common Assumptions About Quality in Business and Life in General
Both FDA inspectors and ISO auditors consider the practices and processes that comprise a corrective and preventive action (CAPA) program to be singularly critical to compliance.
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ISO 13485 - Change? Do I Have To??
Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system.
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How Effective Training Management Can Help You Prevent Quality Issues
“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl.
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5 Tips for Getting Executive Backing for a New or Expanded EQMS
There are many reasons for interdepartmental resistance to system adoption, but the most common is the lack of understanding of the value of quality.
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Cost of Inaction - Taking Quality Management Processes Digital
In the past decade, technological advancements in process automation and enterprise software have made investments in quality management improvements strategic and sustainable.
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What is the True Cost of Not Having an EQMS?
Can you afford the risk of a low quality product due to an inefficient or unsustainable QMS?
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The Pros and Cons of Buying Vs. Building a Quality Management System
Regulated companies investigating a quality management system usually fall under two categories: the small company with no QMS at all, or the established company seeking to improve its existing QMS.
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Annex 11: The EU's New Expectations for Regulated Computerized Systems
This white paper summarizes Annex 11 to clarify the guidelines for when a computerized system replaces a manual operation.
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Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean
Most CEOs and top managers just don’t get it when it comes to ISO 9001 and all the derivative standards. This white paper offers quality strategies and compliance ideas that can educate executives.
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ISO 17025: What it Means for You and Your Laboratory
Keeping up with ISO 17025 standards isn't easy. These standards provide proof that first, second or third-party laboratories are competent enough to test, calibrate and take specified samples.
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Meeting ISO 9001:2008 - Standards with Automated Tools
Introduces the requirements of the ISO 9001:2008 standard and the benefits of automating document control and quality management processes that are required to meet the certification standard.
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cGMP and ISO 13485 Integrated Quality Management System
The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP).
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Understanding ISO 13485: 2016 — A Brief, Yet Comprehensive, Overview
Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities, and obtain recertification to the new revision.
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