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Apr 29, 2015

Cut through the Clutter: Simplifying Regulatory Compliance

Cut through regulatory red tape to improve
quality, compliance and time to market.

by David R. Butcher, Marketing Communications, MasterControl

For any business, the process of getting a product to market – from concept initiation through release – is often long and arduous. For manufacturers that must navigate the maze of regulatory red tape, hoops and hurdles, the process of bringing an innovative product to market can be even more punishing and the stakes even higher: one wrong step can stall or completely derail the entire product development effort, giving competitors a major advantage in the race to market.

As highly regulated companies’ leaders look to bring their innovative products to market, many consider mounting regulatory pressure a key disruptive issue in their industries moving forward.


In a 2014/2015 Emergo survey of more than 2,200 quality assurance and regulatory affairs professionals in the medical device industry worldwide, respondents in all regions said their work isn’t getting any easier in terms of regulatory requirements. Overall, regulatory compliance was said to be getting more challenging in many key markets. When the medical device regulatory consulting firm asked more than 600 executives to identify the biggest challenges they face, “changing regulatory requirements” was topped only by “financing.”

Other recent findings, based on PricewaterhouseCoopers’s (PwC) 2015 global CEO survey, indicate that the top threat to business growth prospects is over-regulation. Based on interviews with more than 1,300 company leaders in 77 countries, PwC’s survey findings indicate that 78 percent of CEOs are concerned about over-regulation, up from 72 percent in 2014 and 69 percent in 2013.

As regulatory challenges continue to rise for manufacturers in all industries, so too does the need for tools to help navigate the increasingly complex regulatory landscape.



Enterprise quality management systems (eQMS) that enable robust recording keeping, traceability, change control and document control can help highly regulated companies tackle the challenges that tend to slow down development and manufacturing processes. That is why, for many regulated companies, an eQMS is becoming an integral part of their overall plan to shorten the time from product design to delivery while remaining compliant.

This article is related to the Video: MasterControl QMS Made Simple.

An effective eQMS can help regulated companies achieve faster time to market in a number of key ways:

  • Streamlining critical processes – An effective eQMS will improve efficiency related to quality processes critical in compliance. Automating tasks like routing, tracking, escalation, review and approval of documents and forms will help simplify the compliance environment by standardizing and streamlining processes and promote efficiency. Reducing bottlenecks and streamlining processes through automation will help cut down throughput processes and cycle times significantly.
  • Improving communication and collaboration – An effective eQMS will extend communication and collaboration across multiple departments, facilities and suppliers, and makes this communication available to all parties involved, including auditors. This means less time waiting for documents to be routed and approved or tasks to be completed, and more time focusing on higher priorities. The end result is faster time to market at a lower cost than with manual communication processes.
  • Mitigating risk of noncompliance – In addition to maintaining efficient processes and effective communication, highly regulated companies must also document everything they do in a way that complies with regulatory requirements. One simple mistake within an otherwise-adequate development plan can cause costly product delays. An effective eQMS will help avoid potentially devastating delays and ensure compliance with even the strictest requirements imposed by the FDA, ISO, EMEA or other regulatory bodies.

The regulatory drivers are only part of the appeal of an eQMS. The competitive advantage opportunities gained by automating quality processes are equally compelling. As federal regulations and international standards increase, further complicating an already-complex regulatory environment, companies that adopt an effective eQMS will be better positioned to increase efficiency, decrease risk and maintain compliance – ultimately delivering higher-quality products to market quicker than their competition.


To learn how MasterControl helps companies navigate complex regulations to get their products to market faster, check out this video or contact MasterControl.


David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends newsletter and blog and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions magazine. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.


Resources:

1) “Outlook for the Medical Device Industry in 2015,” Emergo, January 2015. http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey

2) “18th Annual Global CEO Survey,” PricewaterhouseCoopers, January 2015. http://www.pwc.com/gx/en/ceo-survey/2015/



Watch Related Videos

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White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
Product Data Sheet: MasterControl Suite Overview
Product Data Sheet: MasterControl Documents™
White Paper: ISO 9001-2000 Standards: Automating Quality Systems



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