ROBAR Saves Hundreds Of Staff Hours in IT Administration by Virtue of Its Enterprise Architecture and Innovative Web Interfaces.

Even with the expertise and dedicated resources of an entire software company, developing and maintaining an FDA-strength labeling system is a considerable task. Thus, it is rarely “if ever” practical for a Life Science manufacturer to build the ideal system in-house, given the number of additional systems and commensurate work for which its IT group is responsible. Consequently, most medical device and pharmaceutical manufacturers end up with a custom label system that has numerous significant drawbacks. An effective and efficiently designed labeling system provides immediate benefits by substantially reducing administrative overhead.

Administrative Drawbacks of Homegrown Label Systems:

• Limited Functionality: Every business software system must address the needs of two major stakeholders: those who use the system, and those who administer the system. The result is typically a compromise with major sacrifices on both sides. On the Administrative side, this often means a de-centralized system with multiple stand-alone installations spread across any number of business units and physical locations. Thus, IT is forced to manage systems at the individual site level, or even user-level to avoid inconsistent versions, data, templates, policies and procedures.

• System Conflicts: A homegrown label system is typically built from multiple, mass-market OTS software applications tied together with custom programming with little or no input from the original developers. Thus, while it may work initially, there are no guarantees it will continue to work as the OTS developers release new versions of their respective products. After all, no mass-market software company can reasonably be expected to improve its product and address all conceivable customizations in its user base. Consequently, pharma and device IT Groups either freeze their custom systems at explicit version levels for all components and learn to live with any shortcomings, or they deal with costly conflicts and re-validation if they wish to improve their custom systems.

• Labor Intensive: Given the aforementioned decentralized structure typical in homegrown label systems, IT faces a monumental administrative workload in terms of:
  • Installation: Clients are installed on a machine-by-machine basis, often requiring a physical installation on-site.
  • Maintenance: Lack of centralization also means that any system maintenance work is duplicated numerous times across multiple sites and workstations.

Upgrades & Updates: Again, the decentralized nature of custom label systems requires duplication of any upgrades or updates.

Administrative Benefits of ROBAR:

Since Innovatum was founded by technology professionals with decades of experience managing FDA-regulated IT operations, we have faced the administrative challenges of homegrown systems in the Life Sciences first-hand. Consequently, we built ROBAR with the flexibility and sophistication to eliminate these shortcomings:

• Enterprise Architecture: ROBAR retains all label templates, variable data and system settings on a single enterprise server accessed by remote clients. This ensures consistency across any number of users, sites and business units with minimal administrative overhead, which reduces both labor and regulatory exposure.

• Server-Level Administration: ROBAR allows IT to globally manage system settings, version levels, user access rights and a host of other administrative functions in a single network location. Therefore, instead of managing administrative activities on a site-by-site or user-by-user basis, they are performed once in a central location and automatically applied to remote clients.

• Web-based Approvals: The available workflow module replaces cumbersome paper-based approval SOPs with automated electronic workflows. It does not require a client-side installation, which simplifies implementation and saves system resources since clients merely run a web browser versus an installed application. It also allows authorized users to view approval activities and statuses in real-time from a secure web portal.

• Simplified Updates & Upgrades: While ROBAR meets the vast majority of user requirements out-of-the-box, new customers routinely request new features to meet their own specific needs. Sometimes these features are highly proprietary and other times they offer potential value to the market at large. In either case, all new ROBAR features are added to the base product as standard functionality. Thus, in the event of an update, IT can choose whether or not to activate new features by turning them on in the system settings file. If they do not activate any new features, the new version behaves exactly like the previous version. In other words, ROBAR eliminates the need to back-apply and re-validate any label system customizations.

• Configuration vs. Customization: At Innovatum, we firmly believe in empowering our customers with the tools to implement and manage their FDA-regulated software with minimal assistance. Consequently, ROBAR has unrivaled flexibility to ensure that most  if not all user requirements can be met out-of-the-box by configuring system settings, versus custom programming:

• • Field Names: All ROBAR field names can be edited by Administrators to match internal nomenclature and SOPs.
  • System Settings: ROBAR incorporates best practices from multiple leaders in Life Science manufacturing. As with any complex process, however, there are multiple ways to achieve the same outcome. Thus, ROBAR gives Administrators the power to configure each function to best meet their specific needs and existing procedures without the need for custom programming. If you would like to learn more about how ROBAR’s powerful administrative capabilities can help improve your regulated labeling operations, contact us for a free consultation.