Innovatum Offers a Full Range of Professional Enterprise Labeling Services for the ROBAR Enterprise Label Management System
ROBAR is a complete bar code and RFID label design, review, approval, printing, data management, and regulatory data submission system built specifically for regulated manufacturers in the Life Sciences (i.e. pharmaceutical, medical device and biotech). It’s database is designed to support 21 CFR change tracking and it is easily extensible to be used as a PIMS (Product Information Management System) for labeling and a RIMS (Regulatory Information Management System) for regulatory submissions worldwide. Innovatum offers a full range of professional enterprise labeling services in support of a ROBAR implementation. These services are available a la carte depending upon the intended uses of ROBAR:
- URS/FRS Review & Gap Analysis: Once a ROBAR project is approved, Innovatum thoroughly reviews requirements with the customer’s Project Team and user community during a project kick-off to explicitly identify any gaps in current functionality that will need to be addressed during the implementation.
- System Design: Once the URS/FRS and SOP analyses are complete, an Innovatum technical architect works with the customer’s Project Team to synthesize the results into a comprehensive system design, identifying all relevant configuration variables, integration points and development requirements.
- Data Mapping: The correct data on the correct label is the ultimate goal of any regulated labeling system. Consequently, ensuring that a customer’s existing data repositories are effectively interfaced and/or replicated in ROBAR is vital. Thus, for clients that elect to retain Innovatum consulting resources for the Data Mapping process, an Innovatum resource works with the customer to identify all existing data and sources that will need to be transferred to the ROBAR Server Database, including relevant field names, tables, etc.
- Label Format Analysis & Conversion: When migrating to a new label system, customers often have to convert their previous label templates. Innovatum provides the option to analyze the customer’s existing label templates, then devise and execute a comprehensive conversion plan, including: label template conversion and consolidation, as well as new template design.
- Gap Remediation (development): ROBAR typically meets 95-99% of customer requirements “out-of-the-box” via configuration. However, the interpretive nature of compliance often requires some minor new development to address each customer’s unique SOPs, and/or operating environment. Consequently, Gap Remediation is the process Innovatum developers perform as a result of the URS/FRS & SOP analyses, and subsequent System Design. If the customer requires new functionality that has significant potential market value, Innovatum may elect to add that functionality to ROBAR at a substantial discount based on certain commitments from the customer. New features that are highly specific to a single customer, however, are subject to Innovatum’s standard consulting rate.
- Installation & Configuration: ROBAR is relatively simple to install compared to most enterprise-class software systems. For multi-site implementations, however, Innovatum strongly encourages utilizing Innovatum consulting resources, given the scope and volume of configuration variables.
- System Integration: ROBAR employs a standard XML data interface to seamlessly integrate with external enterprise systems. The System Design process described above identifies the explicit integration activities required to address each customer’s unique operating environment and processes. Consequently, System Integration is the execution of those activities by Innovatum developers on the customer’s behalf.
- User Training: While often overlooked, few aspects of an enterprise software project are more important than equipping the user community with the tools to maximize the benefits of the software in their daily work processes. As a result, Innovatum offers a full range of both on-site and remote ROBAR training services.
- Validation: Innovatum offers a complete Validation Documentation Packet for ROBAR, as well as a full range of validation services from resources with extensive experience in FDA-regulated environments. Since ROBAR is a “commercially-available off the shelf” (COTS) system with existing validated installations, some companies merely run the generic scripts and protocols with sample data, then perform a supplemental validation on functions/processes that are high-risk and/or specific to them (i.e. unique SOPs and/or infrastructure). Other companies require a more extensive validation; localizing the documentation to reflect their unique ROBAR installation, and executing protocols and scripts at each site. Regardless, Innovatum has the knowledge, experience and resources to manage the entire process from start-to-finish if necessary.
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