ROBAR – Master Data Management System
ROBAR MDM can be used to effectively manage regulatory data as a RIMS (Regulatory Information Management System) and provide it to ROBAR Labeling along with PIMS data (Product Information Management System) for use in label printing. ROBAR Master Data Management System can also be used in conjunction with ROBAR COM to manage regulatory data, conduct pre-submissions testing and submit regulatory data to the FDA GUDID and other regulatory bodies such as (Canada, China, Brazil, Turkey, Taiwan, EU, Argentina, etc.) once these regulatory bodies release their specific requirements. In short, ROBAR MDM can house and pass through data which can be used for labeling, for regulatory data management and submission or do both in combination. Use of the complete ROBAR product family eliminates siloing, redundant approvals and the need to keep multiple databases in synch while waiting for cloud based regulatory databases to accept submitted records.
With many customers shipping life sciences products to Europe, and as members of the Medtech EU MDR working group for Eudamed Machine-to-machine (M2M) communications, Innovatum employees are Eudamed experts. Understanding what is needed and how to deliver it. The data stored within the ROBAR MDM system can also be an important part of Life Sciences Track and Trace mechanisms. Tying everything together including storage of information for the Patient Information Leaflet. ROBAR MDM stores data and associations which enable compliance with: Implementing regulation 2021/2226 Basic UDI-DI, eIFU – 2021/2226 Regulation as well as information for use with MDR-IVDR compliance. ROBAR MDM stored information can even be used for Pharmacovigilence.
ROBAR MDM is capable of importing information from spreadsheets, allowing for controlled browser based access for manual data entry and or data maintenance, and also can receive variable data that is being managed and stored within other systems. It is a life sciences specific regulatory master data management system that enables the grouping of fields into schemas, assigning controlled browser based access to various groups or persons so they can manage the data they are responsible for and can roll the data up for labeling or submission purposes. It allows for for auditable and easy review, approval, and change management of related data all in a 21 CFR compliance capable manner. Best of all, with ROBAR MDM you no longer need to put in a change request to IT to add a field or regroup related fields, wait months and then revalidate once requested changes are made. ROBAR MDM removes complexity and is a must have for organization which use contract manufacturers and suppliers or provide OEM products for their customers.
All of this is handled by a multi-enterprise master data management system that:
- Has a virtually limitless, configurable database which does not require re-validation after configuration changes (the addition of fields, grouping of fields, etc.) are made
- Allows for effortless connectivity to other systems inside of or outside of your enterprise
- Is automatically version controlled with electronic signatures and Part 11 compliance
- Provides one-click access to a history of changes for each record
- Enables efficient and effective data reuse
- Supports Excel data import
- Supports manual data entry through a browser
- Dynamically retrieves data from appropriate ERP, PLM, MES and XML Publishing Systems within the enterprise
- Enforces business unit level and column level security, enabling each department to manage their own data
- Has user configurable drop-down selections
- Allows entry in HTML or rich text format to support scientific notation, subscript and superscript, branding, and more
- Supports the ability to select multiple entries from a list (i.e., configure kit components or multiple patent numbers)
- Provides immediate and easy access to records in various stages of preparation and submission
- Makes its data available for publication in Excel and documents including, but not limited to labels
- Includes a multi-user, browser based workflow system for review and approval of data
- Presents each user interface in the user’s preferred language
ROBAR – Communication Manager
Once a cleansed and verified repository of data is achieved, any number of external entities can be the recipient of their data segment. Direct upload of UDI information to the GUDID is an out-of-the-box feature of Innovatum’s ROBAR Communication Manager. However, companies may want to upload data to GS1’s GDSN via one of the data pools, subsequently updating the GUDID. The modular and flexible nature of the ROBAR Communication Manager will allow for a blend of targets for transmitted data. Each additional external data partner such as DoD IUID and the potential FDA SNI database is managed through an individualized plugins.
The ROBAR Communication Manager will support:
- Selecting blocks of records that meet filtering criteria (e.g., internally approved status, family, product name, device class, etc.)
- An easy pre-check of selected records for data accuracy and validity
- Controlled correction of errors identified by submissions pre-checks
- AS2, HL7, and XML
- Automation of communication protocol configuration and data mapping to a trading partner’s database such as GUDID, GS1 GDSN Datapool provider, etc.
- Responding to various levels of partner system acknowledgement and error feedback, prompting correction and resubmission
- Approval workflow management, change management, and retention of auditable history to be used for meeting compliance requirements
- Summary and detail reports in PDF format
- New plugins creationn for future targets such as EU’s version of GUDID, custom systems or other regulatory bodies as they release their requirements
- Enforcing time sensitive auditable corrections
Contact us to learn more about the ROBAR Master Data Management System.