The biotechnology industry has mushroomed over the past decade, with revenues increasing from $8 billion in 1992 to $39 billion
in 2003,1 and it shows no signs of slowing down. New therapeutics are entering and pressing through clinical trials. Treatments are
emerging from clinical trials ready for marketing and scaling up for commercial production, leading to a growing need for
new facilities.
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All this growth means that the industry is now facing unique challenges and opportunities in all areas, including managing
assets such as instruments and production equipment. Scaling up naturally increases the volume of assets that need to be managed.
At the same time, moving into marketing and commercial-scale production means that more and stricter regulations apply, increasing
the level of audit scrutiny and the attention that must be paid to compliance. Furthermore, with larger and more sophisticated
processes in place, the costs of downtime increase dramatically. To reduce downtime, additional attention is required when
scheduling maintenance or calibrations, determining frequency of preventive maintenance, and routing approvals to get a piece
of equipment back into production.
Added to the challenges presented by growth is the extraordinary pressure from investors to produce or improve profits within
an unusually short timeframe. This pressure translates into getting a new facility up and fully running at lightning speed.
In terms of assets, this means selecting (following GAMP 4 guidelines for steps such as User Requirements Specification [URS]
development and gap analysis),2 installing, calibrating, and validating each piece of equipment, each instrument, and all related systems and processes.
This process not only applies directly to the equipment and instruments, but also to systems used to manage ongoing calibrations,
maintenance, and validations of those assets. With strict compliance goals, this means new facilities must be brought on line
quickly, correctly (following all regulations), and on budget. These three objectives are rarely achieved simultaneously.
Quick Recap
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The good news is that new biotech facilities, which do not have legacy computer systems to consider, are uniquely positioned
to take advantage of the latest software applications that consolidate asset management. Unlike single-point solutions with
add-on "modules," these new systems bring calibration, maintenance, and validation into a single application without forcing
any department to compromise how it works in order to collaborate with others. These "regulatory asset management" (RAM) systems
reduce duplicated efforts, simplify compliance, and maintain control over the validated state of assets.
Maintaining the Validated State
Biotech companies are under intense regulatory scrutiny. The management of instruments, equipment, and processes must be accurate
and carefully documented. To demonstrate that assets are properly managed, the assets must first be validated, documenting
that they are working as required and promised by the vendor. This original validation requires documented evidence that the
entire production system results in consistent output. This necessitates performing initial qualifications, including the
design, installation, operation, and performance of new instruments, equipment, processes, methods, and systems. Then, over
the course of the asset's lifetime, procedures must be in place to keep the asset in that validated state, including regular
calibrations and maintenance, and revalidating the asset when something alters its operation, requiring complete approvals
before it can be used again.
To achieve their goals, validation specialists use a wide range of systems and tools, including project management systems,
document management systems, change control systems, and systems used to manage calibrations and maintenance. Changes to records
in any of these systems must pass through a specific approval process before they can be accepted as part of the validated
state.
Regulatory agencies expect to see evidence that routine calibrations are being performed to keep instrument readings within
tolerances acceptable to the process involved. These calibrations include using an approved standard to take readings at different
set points before and after any necessary adjustments are made to determine whether the asset was and is performing within
the process tolerance. If the asset is found to be out of calibration, then products and processes affected by that asset
need to be discovered and corrected.
