1. Business Intelligence Solutions
Quality System Solutions for
FDA Regulated Industries
www.busintellsol.com
Telephone: 781 589 0013
FDA COMPLIANCE: IS IT A PRIORITY
Business Intelligence Solutions
www.busintellsol.com
781 589 0013
Jon Nugent
Practice Manager Life Sciences
jnugent@busintellsol.com
Quality System Solutions for
FDA Regulated Industries

2. Executive Summary
FDA COMPLIANCE: IS IT A PRIORITY FOR YOUR BUSINESS?
Many pharmaceutical, biotech and medical device executives realize the responsibility for FDA
compliance is one of the many frustrating and never ending aspects of the job. A well-prepared and
thoroughly executed Quality Control and Compliance system is not only one of the more stressful parts
of the job – it’s a necessity to ensure compliance at every step of the organization’s operations.
Despite the fact that Quality Control is so necessary, a lack of quality control measures and
implementation procedures continues to hurt businesses. It ends up on the back burner for many of
those tasked with the responsibility for maintaining compliance in their organizations.
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You may be thinking that your compliance is acceptable and intact, and that merely the presence of a
Quality Control, Compliance or Assurance department and its operations are sufficient enough to ensure
compliance. If you haven’t been concerned about whether or not your Quality Control Systems are up
to par, and if your company could withstand an FDA Audit, or receipt of a 483 warning letter, consider
since 2009, 483 Warning Letters are up 23%.
Taking a few simple steps to ensure appropriate Quality Control measures and operations are in place
could save you a big headache later – and it could also save your business.
Many executives and other upper level management are aware that they need to intensify Quality
Control directives within their businesses, but the “status quo” has changed. Many organizations are not
aware that it is not enough to ensure acceptable Quality Control in today's zero tolerance FDA
environment. To ensure that your operation is in compliance, you will need to do more.
Start by organizing an internal audit. If there’s any doubt that you could survive an FDA Audit, or that
you’re in compliance with FDA Regulations, it’s time to develop a corrective protocol. This protocol
should become top priority, not only to you and upper level management, but to ALL employees –
particularly those at the Quality Control level.
Quality Control staff should be working with you to implement a compliance structure that will ensure
all employees comply. Your audits should also be implemented regularly, to ensure that any corrective
measures are maintained between audits.
Proper Quality Control to ensure FDA compliance isn’t just an ordinary hassle of the job – avoiding
proper compliance measures, whether due to cost or convenience, has been a direct cause of
businesses shutting down before, and will again. It’s important that you understand what challenges
your business is facing, and if necessary, work with a cost-effective strategist or consultant to help
develop Quality Control measures that meet the criteria set forth in FDA regulations.
Jon Nugent | Business Intelligence Solutions | T: 781-589-0013 | Fax: 781-687-9151 | email: info@busintellsol.com