Preparing regulatory submissions to Health Canada is an increasingly challenging document management task for pharmaceutical regulatory affairs professionals.
You not only have to be an expert in Health Canada regulations and processes, but you also have to be a master in information management systems.
Your company has not only more data but also more types of documents and myriad places to be stored.
Figuring out which file is the most recent file in this mess can be very time consuming, requiring lots of manual emails and back and forth discussions with document owners.
And if you end up with an incorrect piece of information in your submission because one of the thousands of documents and files that are part of it was out of date, the whole submission could be rejected, delaying your company’s time to market for new products.
You’re under more pressure than ever before. DITR is here to help ease that pressure.
Our Regulatory Information Management Solution is based on industry leader M-Files QMS document management solutions, customized for Pharmaceutical regulatory document processes and Health Canada requirements.
PRIMs helps regulatory professionals reduce the amount of time needed to prepare regulatory documents and improve the overall accuracy, ensuring that submission deadlines are met.
Configured with an understanding of Health Canada’s specific regulations to improve your compliance success in Canada. More than 50 document classes / major types related to Drug Master File (DMF) and clients GMP quality documents (SOP, Change Control, Deviation, Complaint, Adverse drug reaction, CAPA, Recall, Sanitation Record, Pest Control Record, Temp Monitoring, Audit, , Inspection …)
Pre-tailored for the standard processes in the pharmaceutical regulatory process, and is further customized to your company’s unique business needs. This includes complicated processes like Product Release and less complex like reviewing quality documents.
Manages information based on what it is rather than where it is located. The metadata-driven and repository-neutral approach lets users manage and organize content in context regardless of where it is stored. Finding and managing information has never been so easy.
Uses artificial intelligence to analyze, categorize, and tag information automatically. This helps users to file data with correct metadata and hence makes finding business-critical information faster. You can also manage all kinds of business records like customers and cases, not just documents.
Has built-in approval workflows and digital signatures ensure documents are routed to the right person for immediate sign-off, eliminating the time wasted chasing signers, printing documents, scanning documents, and re-doing them when the wrong person signed it.
Full visibility on every action taken by individuals working on any contents or documents, which helps you quickly correct errors or answer questions during audits without wasting time to search.
Ensures that everyone is always working on the most current version of every part of the submission document, preventing mistaken information from prior versions from creeping in.
You can control your information workflow and manage information across systems and repositories. Find and tag business-critical data and turn unknown and unmanaged data to managed data.
Your business will be FDA 21 CFR Part 11 and Health Canada compliant
Your data and documents are controlled by role, protected by extensive built-in security features to make sure your data stays safe.
You will minimize human errors that increase regulatory risk with built-in workflows, task tracking, and ensure compliance with industry standards and corporate document policies.
You can find any information as once stored in PRIMs all documents including regulatory documentation, lab reports, clinical documents, project files, general business docs are all instantly searchable and accessible to the most recent version, eliminating searching through confusing folder systems.
Flexible workflow and notification features make it easy to route information to the right people for follow-up and approval, eliminating manual process and errors for immediate productivity gains.
All data records and documents are version controlled, you can easily know the detailed of each version, roll back to any version and have full visibility on what is going on through audit trails.
Electronic signatures will save you the time and efforts to sign paper documents, fully integrated with all your processes and documents with maintaining a detailed audit trail of all document activity and tracking activity by individual, PRIMs gives you the controls to ensure compliance.
Ensure that internal and external stakeholders use one common version of files, eliminating duplicate versions and wasted time emailing comments back and forth.
Manage and track electronic records through their lifecycle, from creation to possible disposal, compliant to your organization’s retention policies
March 19, 2019