Regulatory requirements have become ever more complex, and understanding how to navigate the compliance process is critically important, especially when drug or device approvals hang in the balance. Essex has many years of experience supporting customers in determining their needs and validating their systems, including in-depth knowledge of 21CFR Part 11, the Food and Drug Administration Amendments Act (FDAAA) and Disclosure requirements.
Essex has developed a proprietary approach that ensures the appropriate level of compliance. The Essex approach:
- Emphasizes industry best practices such as Human and Health Services (HHS), Good Automated Manufacturing Practice (GAMP), National Institute of Standards and Technology (NIST).
- Utilizes a comprehensive Essex Tailoring Questionnaire to confirm the business and validation scope, regulatory compliance determination level, method, deliverables output and estimated work effort to be applied to the client engagement.
- Assesses the customer needs using both quantitative and qualitative measures, and from the vendor, system, and organizational perspectives
Learn more about the Essex Regulatory Compliance approach.
Meet Michael Izbicki
Michael has over 20 years of working experience in pharmaceutical clinical and research IT arena. He has led projects across a wide variety of domains, including global business technology management, metrics and process reporting, software testing and release management, and computerized system validation. He is currently supporting the Coordinating Center for Clinical Trials clinical trials reporting program at the National Cancer Institute to ensure the timeliness, consistency and accuracy of clinical trial results posting. Michael holds a Bachelors in Physics from Rutgers University.