Compliance & Regulations

Risk Management and risk avoidance strategies are key in the life science industry. Westernacher advises biotechnology, pharmaceutical and medical device organizations on implementing integrated risk management plans, processes and tools to record, report, quantify and remediate risk.

The Food and Drug Administration (FDA) mandates that any life science company is operated in a state of control that ensure compliance with the Federal Food Drug and Cosmetic Act and portions of the cGMP (current Good Manuacturing Practice) regulations. For life science companies, this translates into Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling as well as Laboratory Control Systems, to ensure products are handled in a traceable, ‘controlled’ manner. Westernacher can help implement the overarching compliance strategy and processes. We also have experience in implementing detailed compliance controls, reports and monitoring tools at the system module or integrated system level.

Not specifically a life science issue, nonetheless an issue every large corporation needs to address; Westernacher can help you implement the processes and controls necessary to ensure SOX compliance of all your financial systems.

In the US most pharmaceutical companies participate in the Drug Rebate Program. Program. Price calculations, data validation, submission and documentation methodologies create a wealth of challenges for companies with integrated ERP environments. Westernacher addresses these challenges by analyzing each companies’ unique situation, sine the underlying data structures determine the best solution and whether an out-of-box package or an integrated custom solution is more viable.

Data sharing and collaboration internally, across sites and with third parties is increasingly important for cost-efficient research and development. Westernacher can help implement and optimize knowledge management tools to share structured and unstructured research information.

Electronic document management systems can greatly facilitate and speed up the work of regulatory departments. However, more often than not these are somewhat stand-alone solutions and not fully integrated into the end-to-end R&D document management process. Westernacher can help life science companies release the full efficiency potential of electronic submissions by making them an integral part of your companies electronic data management solution(s).

Title 21 CFR Part 11 of the Code of Federal Regulations defines the criteria under which electronic records and signatures are considered trustworthy and equivalent to paper records for drug makers, medical device manufacturers, biotech companies and other FDA regulated industries. Westernacher can help life science companies implement Part 11 compliant electronic records and data management solutions as well as implementing it as part of validated systems.