In a perfect world, policy and practice are one in the same. Unfortunately, each year a great number of companies discover only after a DEA investigation that their written policies are not consistently followed. The results of such can mean fines, suspense of registration, and bad public press.
The FixNix consulting experts provides compliance auditing services to help identify and correct issues before they result in regulatory fines. Our compliance auditors can complete company created audits or we can assist in the development of an audit that ensures regulatory compliance. This comes along with the regTech platform of FixNix, FreshGRC.
The FixNix Compliance Consulting Group is the industry leader in regTech solutions, pharma compliance services, and DEA, hospital compliance and audit services.
Our audit and compliance experts are compliance leaders, investigators and possess thorough knowledge of the Controlled Substance Act and the Code of Federal Regulations CFR.
Our compliance and audit expertise and our intricate knowledge of the DEA compliance inspection process allows us to provide our pharmacy, hospital, and pharma distribution partners with programs and audit services that ensure successful execution of the know your customer and due diligence requirements of the DEA, federal and state pharmaceutical regulatory requirements.
Our experience provides us with a unique understanding of the impact of state and federal regulations on your business operations. Our expertise allows us to provide in-depth assessments of your company’s compliance levels, to evaluate the potential risk of fines, and, to examine your exposure to theft and diversion. Our programs provide access to effective solutions to maintain compliance, to ensure due diligence, and to implement an on-going and comprehensive inspection practice.
Offering a comprehensive menu of critical and cost-effective solutions, the FixNix Compliance consulting helps its clients traverse the landscape of regulatory requirements and language and to mitigate the risks associated with operating in a regulated industry.
The FixNix Regulatory Compliance Consulting(RCC) provides compliance programs specifically tailored to hospital pharmacy operations. PCG will work closely with Pharmacists and Pharmacy Technicians to assist in maintaining effective compliance with the regulations enforced by the DEA. Our experts will work together with your pharmacy personnel to identify weaknesses and reconcile issues before they develop into significant problems that could result in fines or adverse actions. PCG will review Standard Operating Procedures (SOP’s), and controlled substance dispensing policies to enhance protocols pertaining to security and recordkeeping, as well as due diligence in a hospital pharmacy environment. FixNix RCC will also develop comprehensive training programs that will provide consistent and uniform protocols relative to dispensing controlled substances in a hospital pharmacy. Evaluations are customized to balance the unique needs of the hospital pharmacy with the requirements of federal regulations without impacting patient care.
FixNix information security services(ISS) cover all aspects of the security space, including:
Strategy – our security program strategy services provide clarity around security strategy and policy design
Architecture – our security architecture and Implementation services help navigate complex environments, apply methodologies and incorporate leading practices to ensure success
Risk – our enterprise risk and compliance services help to address gaps, manage risk and allocate resources to better protect your organization
Training – our education and awareness services address the technical and human elements of your organization to ensure a more secure environment
Threats – our threat and vulnerability management services help uncover intermediate threats and address the root cause of weaknesses
Identity – our identity and access management services help improve business operations and end-user experiences, and transform access requirements into an information advantage
Incident Management – our enterprise incident management services and network security solutions help to secure systems, limited exposure, respond effectively and resolve security incidents of all kinds
Managed Services – our managed information security services are designed to serve as a remote extension of your security staff.
Information security services(ISS) and information security consulting at FixNix are provided by a team of highly respected security experts who perform research, develop solutions and work with clients to solve specific security problems as well as problems for the industry at large.