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


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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