The Food and Drug Administration is a federal arm of the United States government whose responsibilities include the oversight and regulation of products and treatments for use by the general public. At its heart, the FDA is essentially a federally appointed control board to help ensure public safety.Speak With Our FDA Compliance Specialists
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You pride yourself on being a company that pays attention to detail. You make every effort to ensure that your clients are 100% satisfied with your services. And you want to take the same conscientious approach to FDA compliance.
It’s important to get it right.
But keeping up with changing regulations can feel like a full-time job, and you know that you must be overlooking things…and you likely are.
It’s time to consider a partnership with an IT support firm specializing in FDA compliance?
Finding the right IT support firm for your company can be challenging, but you’ve come to the right place!
When it comes to FDA standards, you can’t afford to be someone’s guinea pig. You need an IT support firm with proven industry experience. You need someone who just “gets” you and what you do. We’re ready to deliver a high-level of professional FDA compliance management to your business and to become a part of your team.
Areas we can include in our Managed Security Services include:
The Food and Drug Administration is a federal arm of the United States government whose responsibilities include the oversight and regulation of products and treatments for use by the general public. At its heart, the FDA is essentially a federally appointed control board to help ensure public safety.
The Center for Drug Evaluation and Research (CDER), a subsection of the FDA, published a Manual of Policies and Procedures (MAPPs) which outlines the federal directives and required documentation for all internal policies and procedures. These MAPPs are required by law and detail the mandatory processes for industry-specific compliance with the Federal Food, Drug, and Cosmetic Act as well as other laws instituted by the FDA. This manual outlines the minimum safety requirements to establish a high-quality product worthy of federally approved licensing for the manufacture and sale to the general public.
To assist with the understanding and comprehensive compliance with these regulations, the FDA has compiled and released a Compliance Program Guidance Manual (CPGM) to guide businesses in successfully implementing FDA compliance protocols into their companies.
The FDA spreads a wide umbrella over which companies are required to submit to FDA compliance regulations. As the arbiter of public health safety, its nets encompass (but are not limited to) all food-related services including agriculture and farming, the cosmetics industry, medical research facilities, drug and supplement manufacturing, veterinary medicine, vaccinations, blood and tissue products as well as biomedicine and biotechnology, and medical and radiation-emitting equipment and devices. If a company is involved in the development, manufacturing, or selling of these products in any capacity, that business is required by law to comply with FDA protocols.
Failure to comply with FDA compliance regulations carries penalties which can be quite severe.
Compliance with the FDA is not optional, but there are different routes a business can take to implement required FDA protocols into its workflow.
Through procurement of the CDER’s Manual of Policies and Procedures and the Compliance Program Guidance Manual, some businesses opt to walk through the implementation of all required practices by systematically working through the manuals with their employees.
Other businesses opt to employ a managed IT services firm with expert knowledge of FDA compliance regulations to either work alongside them to meet established FDA standards or to manage the project exclusively. Companies like KalioTek™ have the in-depth knowledge of FDA compliance policies and procedures, allowing them to take the burden of the FDA technicalities off their clients’ shoulders.
The KalioTek™ team can give you complete peace of mind that your business is one hundred percent compliant, one hundred percent of the time.
KalioTek™ is the leading IT support firm for FDA compliance serving the San Francisco Bay and Silicon Valley areas.
Published On: 14th October 2017 By: Mark Richards
KalioTek™ > Technology Services and Technology Management for Bioteck In San Francisco Bay Area > FDA Compliance Standards