The biotech industry also tends to have a complex asset environment. Large quantity and a wide variety of instruments and
equipment common to biotech companies also add weight to the argument for a single comprehensive approach to asset management.
The fact that biotech companies are often under great FDA scrutiny and have tight instrument tolerances also makes a system
designed specifically for FDA-regulated industries a wise investment with a swift payback in the form of simpler audits and
lower risks of non-compliance.
It is also usually easier to implement the latest best-in-class solutions at new facilities rather than existing facilities.
Harmonized systems and processes will be more readily accepted in a new facility than in one where inertia has developed around
the old order. With no disparate legacy systems to replace, implementing a unified system also requires less internal conflicts
than in existing facilities where there may be reluctance to implement a single system if one of the existing systems has
just recently been purchased, implemented, and validated.
With regulatory and business pressures, harmonization within asset management is becoming a necessity within the biotech industry
rather than just a best practice or a source of competitive advantage. A RAM system is the optimum solution to achieve harmonization
without productivity or compliance compromises.
JAMES ERICKSON is president of Blue Mountain Quality Resources, Inc., 1963 Cato Ave, State College, PA 16801, 800.982.2388, JRErickson@coolblue.com
1. Biotechnology Industry Organization: http://
2. Guide for Validation of Automated Systems (GAMP) 4 guidelines, ISPE 2001.
3. FDA Compliance Program Guidance Manual 7356.002, Feb 1, 2002.