Biotechnology

Revenue growth in the biotech industry has increased from $8 billion in 1992 to $39 billion in 2003*. In addition, the number of biotech companies and employees at those companies has seen significant growth. New treatments are entering and pressing through clinical trials. Treatments are emerging from clinical trials ready for marketing and scaling up for full production. Production for successful treatments is being expanded drastically, requiring vast new facilities.

All this growth means that the industry is now facing unique challenges and opportunities in all areas, including asset management (instruments, production equipment, etc). Scaling up naturally increases the volume of assets that need to be managed. At the same time, moving into marketing and full production means that more and stricter regulations apply, increasing the level of scrutiny of audits and the attention required for compliance issues. Furthermore, with larger and more sophisticated processes, the costs of downtime increase dramatically. To reduce that downtime, additional attention is required when scheduling recurring maintenance or calibrations, determining frequency of preventive maintenance, and routing approvals to get a piece of equipment back into production.

Blue Mountain Regulatory Asset Manager was designed with the needs of biotech companies in mind. Without legacy systems to replace, new biotech facilities are uniquely positioned to implement a best-in-class single comprehensive solution for calibration, maintenance and validation. As a single solution, the software also addresses the Facilities & Equipment subcategory of QSIT with a strong systems-based approach. Another significant benefit of Blue Mountain Regulatory Asset Manager to biotech companies is its collaborative features, allowing calibration, maintenance and quality personnel to work together to efficiently manage the validated state of assets and processes.

With Blue Mountain Regulatory Asset Manager, this harmonization and consolidation of systems is achieved without requiring any department to compromise on how they work with assets. Each department has the features they need to work efficiently and meet regulatory requirements, derived from our 15+ years of experience in developing asset management software for life science companies and feedback received directly from users at all levels of these organizations.

Calibration Manager is the industry standard stand-alone Computerized Calibration Management System (CCMS), for biotech companies for whom a single consolidated system for calibration, maintenance and validation does not make sense. With over 1000 validated implementations, Calibration Manager was designed for calibration professional to meet the strict regulatory requirements in the biotech industry.

Added to the above challenges to growth is the extraordinary pressure from investors to produce or improve profits within an unusually short timeframe. This means getting a new facility up and fully running at lightening speed. In terms of assets, this means selecting (following GAMP 4 guidelines for URS development, gap analysis, etc), implementing, calibrating and validating each piece of equipment and instrument and the systems and processes they belong to. This process not only applies directly to the equipment and instruments, but also to the systems used to manage the ongoing calibrations, maintenance and validations for those assets. With the strict compliance goals, this means that new facilities must be brought up 1) quickly; 2) correctly (following all regulations); and 3) on budget: three objectives that are rarely possible together.

With implementation and validation services from Blue Mountain Quality Resources, biotech companies can get up and running quickly without diverting already strained resources from other projects. Our depth of experienced professionals means that many steps of the process can even be performed in parallel, fast tracking the implementation, further reducing time to completion and improving the payback period.

*www.bio.org - "Biotechnology Industry Statistics"