Creating Data Integrity Patterns to Address Multiple Regulatory Requirements
While there are many laws and regulations effecting the complex use and control of data in the Life Sciences industry, there are distinct patterns that emerge that transcend many of the laws and regulations. We believe that creating a data architecture that utilize patterns will provide significant benefits to your organization. Although regulations tend to treat data as a risk, it is also your most important asset and these patterns can provide significant value to your organization. This blog provides a few data patterns that emerge from Life Sciences laws and regulations. Within Life Sciences, there are a myriad of regulatory requirements and standards that you will encounter. A few are listed below with a summary of their intent: 1. 21 CFR Part 11 (ALCOA+) – All data related to patient and product safety must always be in a state of control. 2. HIPAA – All patient data is protected