Regulatory Affairs teams face a relentless challenge: track the right standards, understand their impact, and keep every project aligned: all while the regulatory landscape keeps shifting. Most organizations are doing this with a patchwork of spreadsheets, email threads, meetings, and disconnected document repositories. The result? Missed updates, unnecessary effort, and compliance gaps that only surface when it is too late.

avaRegulatory changes that. It brings Regulatory Surveillance, Regulatory Intelligence, Regulatory Compliance and Regulatory Change Management together in a single, truly digitalized platform in Polarion.

Join us for this launch webinar to see everything that is new in Version 2.0, live and in detail.

What we will cover

Regulatory Surveillance – Efficient Monitoring

Sources of regulatory documents, such as standards databases like DIN Media’s Nautos platform, offer automated monitoring of standards and metadata. This information can be transferred directly into avaRegulatory avoiding manual synchronization of two locations.

Regulatory Intelligence - One source of truth across the entire organization

Having inconsistencies between the global regulatory information database (“state-of-the-art) and local implementation e.g. in product-specific technical documentation is a problem of the past. An automated synchronization is now possible between global (organizational) and local (project) document levels, with built-in notifications whenever a deviation is detected. Your projects always reflect the latest regulatory baseline - without anyone having to chase it.

Regulatory Compliance - Standards in your system, not in a PDF

Import entire standards in ReqIF format directly into Polarion, complete with structured metadata for every individual regulatory requirement. No manual re-entry, no lost context, no broken traceability. The standard becomes a living part of your compliance workflow the moment it is imported.

Regulatory Change Management - Know your gaps before they know you

When regulations change, your system and often your devices need to follow suit. But the question is never just "what changed?" - it is "what is the impact for us?"
The new built-in gap analysis and impact assessment tooling, surfaces compliance gaps automatically, and gives your team a structured, documented path to resolution - all inside Polarion, without switching tools.

The platform advantage - why true digitalization makes the difference

avaRegulatory is not a document management system with a digital label. It is a purpose-built compliance layer that connects regulatory intelligence to product development - enabling automated traceability, real-time collaboration, and compliance reporting that stays current because it is part of your workflow, not separate from it.

Who should attend

• Regulatory Affairs professionals responsible for tracking and applying standards
• Compliance and quality managers seeking a structured, auditable process for compliance and change management
• PLM/ALM tool owners evaluating Regulator Compliance solutions for Polarion environment
• Anyone whose team is still managing regulatory requirements outside their development tools