Regulatory Compliance

Keeping Companies Compliant - Superior Software Paired with Extraordinary Support

Automating labeling regulatory processes improves efficiency while reducing risks and costs. No matter the compliance requirement, abiding by and documenting proof of labeling compliance is much easier with a system that is purpose built for life science packaging and labeling activities. With ROBAR, building in regulatory compliance becomes a foregone conclusion. Whether you are working on regulated labeling, regulatory data management, or regulatory submissions, ROBAR’s compliance capability is always baked in.

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Compliance Capability Baked In

Achieving and maintaining life science labeling compliance starts with purpose-built systems. ROBAR is designed from the ground up to achieve and maintain demonstrable compliance. With robust features like controlled access security, digital signature capture, automatic versioning, 21 CFR Part 11 reporting, Annex 11, secure reprints, before and after data values, and change control, ROBAR provides a solid foundation for compliance and regulatory confidence.

FDA 21 CFR Part 11

All life sciences manufacturers employing the use of computers in their GxP processes need to be 21 CFR Part 11 compliant. Once validated for your specific environment, ROBAR offers complete 21 CFR Part 11 compliance for your compliance-related activities.

EU Annex 11

Compliance requirements for FDA Title 21 CFR Part 11 and EU Annex 11 are somewhat equivalent regulations ensuring electronic record integrity. ROBAR's compliance with EU Annex 11 demonstrates a high level of commitment to data security and regulatory adherence, making it a strong partner for organizations operating in regulated life science industries.

Compliance From The Outset

UDI Compliance

As regulatory bodies around the world put their spin on Unique Device Identification and the way the UDI barcoding will be used, ROBAR offers a flexible solution. Our plug-in approach adapts to various UDI barcoding requirements, minimizing validation effort. This ensures seamless compliance and scalability for medical device manufacturers introducing products into various marketplaces.

EU MDR IVDR Compliance

For Innovatum’s ROBAR, compliance with EU MDR and IVDR is merely an extension of using already proven US FDA UDI solutions. As Eudamed requirements evolve, ROBAR's capabilities adapt accordingly, ensuring ongoing compliance and support for clients navigating the complexities of European regulations.

ISO 9001:2015 Compliance

Realizing the importance of maintaining a Quality Management System for software development, delivery, and support, Innovatum maintains certification. As such, Innovatum is committed to providing products and services of the highest quality, consistent with the needs of our customers and applicable regulatory requirements. Our quality objective is to strive for 100% customer satisfaction.

GxP Compliance

Innovatum conducts regular training for its employees and follows GAMP 5 and a stringent SDLC process for its labeling and compliance software development. We thoroughly test every release and perform regression testing on all enhancements in a branch and trunk approach and validation documentation is made available.

US FDA Drug Supply Chain Security Act (DSCSA) Compliance

Key features include efficient integration with barcode-based packaging aggregation, seamless interoperability with various other systems, and rapid access to product information for surveillance tie-ins.

We Work With Organizations Around the World

We provide complete systems, modular systems, consulting, training, and exemplary 24/7 support services across all borders and time zones.