Minimizing Calibration Risk In Complex Biotech Environments
•White Paper: Minimizing Calibration Risk In Complex Biotech Environments
Risks in biotech companies span all levels of the organization. From business risk – more intense in a young industry, to research risk – whether the treatment will work as promised. Unique to the life science industries are the regulatory risks, which are more intense in biotech because of the greater scrutiny the FDA applies to these companies. As part of the regulatory pressure, a company must prove that their assets (instruments, production equipment, etc.) are properly managed, including calibration, maintenance and validation.
Developing regulatory asset management systems and procedures to contain these risks and enjoy the inherent productivity benefits of well-managed assets can be challenging given the severe resource constraints of growing biotech companies. This pressure is even greater for those who are charged with getting all new systems up and running at a new site.
While evaluating potential systems, it is important to keep in mind that because of the higher number of instruments with tight tolerances at biotech companies and the greater attention given to calibration by the FDA, the management of the calibrations of assets usually poses a greater regulatory risk than general maintenance. Your regulatory asset management system, whether it is a combination of systems or single integrated system, should therefore provide best-in-class calibration management to minimize that risk.
Click Here To Download:•White Paper: Minimizing Calibration Risk In Complex Biotech Environments