ROBAR Enables Full Compliance With Stringent FDA and International Regulations.
21 CFR Part 11 Compliance
Pharmaceutical and medical device firms are regulated by the Food and Drug Administration (FDA). Both industries must conform to 21 CFR Part 11, which dictates that companies making drugs and medical devices must preserve auditable records of the use and activity of electronic systems that are employed in their production, including bar code label systems that are used to identify, store, ship and receive packages throughout the distribution supply chain. Innovatum’s ROBAR Enterprise Label Management System keeps an auditable electronic record of every label design and print change and authorization of every label’s lifecycle. Moreover, ROBAR centrally manages label design authorizations so that once a label is approved and distributed for local printing it cannot be changed.
EU Annex 11
Innovatum has successfully supported all of its clients in their Annex 11 risk assessment activities ensuring complete compliance.
Prescription Drug Marketing Act
The Prescription Drug Marketing Act dictates how drugs are labeled, shipped, stored, marketed and sold. A primary purpose of the PDMA is to prevent diverted and counterfeit drugs from reaching market. Bar code and EPC/RFID track-and-trace labeling systems will play a crucial role in keeping counterfeit and diverted drugs from reaching market by establishing a unique electronic pedigree or record of transactions of each product as it moves through the supply chain. Using the industry-standard XML application interface, ROBAR can access information on corporate databases and ERP and PLM systems and encode this data in bar codes and EPC/RFID tags for secure and auditable supply chain distribution. ROBAR meets the Healthcare Distribution Management Association’s EPC/RFID guidelines for anti-counterfeit supply chain security.
Validation is a significant effort associated with implementing any new system in FDA regulated industries. Given Innovatum’s background in these markets, we have taken a number of steps to reduce this burden. Due to our strict development methodologies and appropriate documentation, Innovatum has been the subject of multiple vendor audits with excellent results. Thus, we welcome customer inspections.
In addition, Innovatum offers a comprehensive Validation Documentation Packet for ROBAR, including: URS/FRS, Functionality Matrix, IQ, OQ and test scripts for every function of the system. Consequently, users do not have to create a validation plan from scratch, which can save hundreds of staff hours and accelerate implementation and go-live dramatically. Moreover, the ROBAR Validation Packet was written by a 25-year veteran of the Life Sciences industry and has been successfully executed at multiple pharmaceutical and medical device manufacturing facilities.