From analytical laboratories supporting manufacturing to basic research that supports late-stage drug discovery, many laboratories find themselves operating in the regulated domain. With proliferating and ever-changing regulations, these organizations are exposed to a greater degree of compliance risk than ever before, especially when operating on a global scale. Compliance risk can lead to legal sanctions, financial loss, or loss of reputation that a company experiences when it fails to comply with industry laws and regulations, its own internal policies, or standards of best practices. Due to the complexity of regulations and increasing penalties for noncompliance, an effective compliance risk assessment that serves to both identify and prioritize risks is a critical first step in the development of an overall risk management strategy for modern enterprises.
As experts in IT risk and regulatory compliance, we have extensive knowledge of both current and emerging regulatory compliance issues across many different industries. We combine this regulatory knowledge with our technological expertise across hundreds of different platforms and deep scientific domain knowledge to help you assess the current state of your laboratory and IT systems with specific focus on data integrity, 21 CFR Part 11 compliance, software validation, user access, calibration and operations. Our compliance experts help you assess and understand the full range of your compliance risk exposure, prioritize those risks, develop robust mitigation plans, and make critical change impact assessments. Armed with the information from this assessment, you will be able to appropriately allocate resources towards risk mitigation strategies that reduce your exposure to financial and reputational loss and lower the overall cost of compliance, effectively setting yourself apart from your competition in the marketplace.
- Privacy Laws and International Data Exchange
- FISMA / FedRAMP
- 21 CFR Part 11
- GxP and Software Validation