Other Healthcare Sectors Served
Healthcare risk management is a significant concern. The pharmaceutical sector in particular is wrought with risks that, if left unaddressed, can significantly impact your organization’s reputation and bottom line. As such, the proactive identification, management and neutralization of these risks is an extremely worthwhile, if not required, endeavor. An experienced, credentialed security professional can assist in identifying the areas of greatest concern and develop plans and programs to manage the risks to acceptable levels. Whether it is a concern with counterfeiting, adulterated products, pilferage or compliance with Title 21 CFR Part 11, Crucible has the practical experience and expertise to properly manage these concerns.
Part 11, as it is commonly called, is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Specifically, Title 21 CFR Part 11 Section 11.1 (a) defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records. Compliance with Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, clinical research organizations and other FDA-regulated industries, with some specific exceptions. Part 11 requires that an organization implement controls, including;
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act or any FDA regulation other than Part 11.
Crucible can provide relevant advice and consultation to more appropriately manage and control access within these areas, to effectively address concerns with counterfeiting, adulterated products and pilferage as well as to ensure compliance with Title 21 CFR Part 11.
The methodology employed will consist of;
Crucible has extensive experience in developing security protocols for organizations that must comply with the Drug Enforcement Agency (DEA) requirements for controlled substances as well as the Prescription Drug Marketing Act (PDMA). Call 201-252-2532 today for a free, no-obligation healthcare risk management assessment to determine your company’s security needs as well as your compliance with Title 21 CFR Part 11, and associated DEA requirements.