Harmonizing Calibration, Maintenance, and Validation
Biotech companies have explored various options to harmonize systems involved in maintaining the validated state, seeking
to achieve improved collaboration and reduce redundancies between departments. For example, many biotech companies have commissioned
custom integration between CCMS and CMMS packages to automatically pass information between applications. This allows each
department to use software designed to satisfy its specific needs for how it manages its assets. By using one application
as the central repository for basic asset information that is then shared with the other application, this approach also eliminates
the need for duplicate data entry, reducing inconsistencies. Each system, however, must be implemented and validated separately.
Individual version upgrades of the CCMS or CMMS also will not likely be compatible with the original integration, requiring
periodic redevelopment work and revalidation of both systems.
Another attempt at harmonization has been to use a single point solution with "add-on modules" (i.e., basic calibration management
functionality built into the framework of maintenance management software, or vice versa). However, being built on another
system's purposefully built framework, those modules involve significant compromises to efficiency and ease of use for individual
departments. For example, a CCMS would lack the sophisticated work order system or inventory management that a CMMS would
have. Likewise, a CMMS, driven by work orders, generally requires additional steps and minutes to complete each calibration,
not a trivial matter when some companies perform tens of thousands of calibrations per year. When considering this option
it is imperative to understand the impact the modules would have on compliance and productivity throughout the departments.
For most companies, however, compromises and costs with existing options have been too great, and as a result, they continue
with separate point solutions, encouraging "off-line" collaboration.
Regulatory Asset Management
The combination of calibration, maintenance, and validation forms the core of regulatory asset management (RAM): the management,
scheduling, data collection, and documentation associated with keeping processes, instruments, and equipment in a validated
state in regulated production and critical research environments. Systems designed specifically for RAM offer an obvious alternative
to biotech companies seeking a best-in-class solution for harmonization of calibration, maintenance, and validation.
In contrast to other solutions, a RAM system truly embraces harmonization; designed to meet the individual needs of calibration,
maintenance, and validation groups while also encouraging a holistic and collaborative approach to asset management and the
validated state. For example, in a RAM system the scheduling or completion of a performance activity can result in automatic
notifications to calibration or validation personnel, to schedule any activity that may result from the maintenance.
A core area in managing regulatory assets is change control. It's in this area that a RAM system really stands out against
applications not designed for biopharmaceutical manufacturing, which often apply limited electronic signatures as modular
add-ons sitting on top of the main application. In contrast, RAM systems provide an integral audit trail, approval routing,
and 21 CFR Part 11 compliant electronic signatures for changes to records throughout the application, from asset and event records to
calibration measurement data templates. Best-in-class RAM systems actively expedite an asset's return to a validated and full
production state with configurable approval routing that match existing paper-based procedures that vary by asset or record
type and sophisticated status management to prevent unapproved records from being used anywhere in production.
The RAM system stores asset information in a single location, eliminating redundant effort and potential inconsistency in
entry. Likewise, such a system offers easy access to a piece of equipment's complete history, useful when evaluating and improving
reliability and uptime, or making decisions on purchasing similar equipment. These are all benefits that auditors also appreciate
seeing, offering a clear systems-based approach.
In addition to bringing all asset information and the approval process under one system, harmonization also reduces the overall
costs of ownership, with lower computer hardware and system maintenance costs, fewer vendors, and minimized validation headaches
and costs. Once a company has made the transition to a single system for all regulatory asset management, taking advantage
of technological advancements is also simplified because there is only a single system to upgrade instead of a compilation
of systems that may or may not have integration issues.
Conclusion
Even more so than other regulated life sciences industries, biotech companies are uniquely positioned to implement and benefit
from a RAM system. First, with pressure to get a new biotech facility up and running quickly, anything that can reduce the
number of projects means becoming operational that much quicker. In this context, one system to implement is better than three
or more separate systems.
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