RIM software features you can really rely on

See what’s inside RegDocs Connect, Montrium's regulatory information management system built to do the heavy lifting behind regulatory compliance and facilitate complex regulatory processes, every step of the way. Regulatory information management (RIM) systems provide organizations with the peace of mind that all regulatory activities and regulatory affairs are up to speed. Learn what RIM system features you should start taking advantage of today.  

Document management features

Montrium's regulatory information management (RIM) system allows users to speed up and improve processes that support regulatory submissions while staying within the complex bounds of regulatory requirements and region expectations. RIM systems like RegDocs Connect ensure the management of regulatory documents simple, as it should be.

Document template center & file plan

Accelerate and streamline the process of creating and filing documents with a dedicated template center and configurable file plan directly in your regulatory information management system.

Real-time collaborative authoring

Remove friction in the document drafting and review process by taking advantage of real-time, collaborative authoring with built in version control, a favourite regulatory information management system perk.

Configurable review & approval workflows

Dynamically drive the document lifecycle with centrally managed tasks and automated workflows, significantly speeding up the creation, review and filing of TMF content.

 21 CFR Part 11 & Annex 11 compliant electronic signatures

Keep the compliance part of regulatory information management simple by ensuring your records are compliant with 21 CFR Part 11 & Annex 11 compliant digital signatures.

Built-in PDF/A conversion engine

Regulatory information management processes don't need to be slow. You can speed up file conversion and avoid third party tools by leveraging a built-in PDF conversion engine.

Native integration with M365 & Office

Seamlessly connect your quality environment to your business operations with native Microsoft 365 and Office integration.

Aligned with eCTD & EDM Reference Model taxonomies

Pre-defined configuration and taxonomies are fully aligned with the most up to date information and up-to-date versions of the electronic common technical document (eCTD) and EDM reference model.

Google-like search & retrieval tools

Make finding and retrieving documents as simple as looking up a nearby restaurant with Google-like search tools. Regulatory information management software and systems make it that simple.

Records center for archiving

All final records are stored in a secure record center allowing easy review of submissions and sequences by anyone with access.

Submission management features

Consider Montrium's regulatory information management software your sidekick that keeps your regulatory affairs team in harmony, hassle-free. Think real-time status of your submissions so you can identify gaps and track all activities from one simple interface. It's time to make regulatory tasks less daunting with intelligent RIM systems like RegDocs Connect.

Real-time submission readiness reporting

Gain real-time visibility into the status of submission-readiness, identify potential risks and access key information so you can make the most informed decisions in your team.

Manage submission plans & document indexes

Plan document packages and manage product dossiers faster with built-in eCTD document type mapping and auto-placeholder generation.

Export to ZIP & Excel for content portability

Get maximum content portability with robust export functionality including content pre-formatted for eCTD ready for publishing.

Global submission planning

Create a team of high performing regulatory professionals when you provide them with the tools to track and effectively manage all ongoing submission activity in the regulatory life cycle from one interface.

Export to eCTD publishers

Seamlessly transfer your submission-ready regulatory documents to your electronic common technical document (eCTD) to increase speed to submission.

Product information store

Store all the critical information that relates to your product as metadata within the RIM system. 

Track correspondence & commitments

Mitigate risks related to your submission as you easily manage interactions with global regulatory agencies. Track communications and commitment activity where you team is working.

Built-in submissions archive

Bring back in previously submitted sequences to the submissions archive for future reference in a controlled and centralized repository.

Built-in eCTD viewer

Read and navigate eCTD NeeS and other electronic submissions with our XML viewer conversion, just as the health authorities have.

Administration, security & compliance

Regulatory information management systems like RegDocs Connect come with built-in compliance and top notch security amongst a slew of other first class features that will make RIM systems like ours your new favourite team member.

Aligned with GxP requirements

Effortlessly achieve GxP regulatory compliance and streamline processes with a system that’s purpose-built to align with relevant laws and uphold the regulatory requirements.

Compliance with GDPR from the ground up

Sleep easy knowing that the activities your team conducts will always be done so in a platform the upholds data privacy expectations. Focus on critical projects while we ensure compliance with the relevant governmental bodies.

Robust security & access management

Robust security and access management lets you share what needs to be shared and protect what needs to be protected.

21 CFR Part 11 & Annex 11 compliant

Rest easy knowing that your regulated content meets full regulatory compliance with 21 CFR Part 11 and Annex 11.

SSO & active directory integration

Avoid frustrations with logins, security, and network administration thanks to SSO and active directory integration.

Quality management software aligned with ISO standards

Our quality management system has been thoughtfully aligned to the ISO standards for quality management software.

Built with industry best practices & standards in mind

Stay consistently aligned with industry standards, global regulations and best practices thanks to a RIM system that’s built on them. We take evolving regulatory requirements seriously.

Custom integrations available with other systems

Centralize and streamline regulatory processes and regulatory activities with custom integrations for existing systems to make system-to-system communication easier.

Advanced data export & content portability

 Take your data wherever you need it. Our RIM system's built-in export functionality allows you to port content and data to be used across your organization 

Ready to upgrade your regulatory information management processes?

See Montrium's RegDocs Connect in action with a live demo.

Secure & private by default

We take the responsibility of helping you manage clinical trial data, including regulatory data, seriously. That’s why security, quality assurance and compliance are key focus areas for our organization and product development. 

Rapid implementation & validation

Implementing regulatory information management software in the life sciences industry has changed dramatically. Leverage our team of industry vets as we guide you from zero to regulatory hero in as little as 4 weeks.