Asset Management for Growing Biotech Companies - Biotech companies with new facilities are uniquely positioned to implement and benefit from a regulatory asset management (RAM) system. - BioPharm

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Asset Management for Growing Biotech Companies
Biotech companies with new facilities are uniquely positioned to implement and benefit from a regulatory asset management (RAM) system.


BioPharm International


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,

References

1. Biotechnology Industry Organization: http:// http://www.bio.org/speeches/pubs/er/statistics.asp

2. Guide for Validation of Automated Systems (GAMP) 4 guidelines, ISPE 2001.

3. FDA Compliance Program Guidance Manual 7356.002, Feb 1, 2002.


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