SOP Management
Document Control Lifecycle Management for SOPs and Quality Documents
Montrium’s SOP Management Module is a document control solution designed to manage all controlled quality documents that form part of your quality system. Easy access, centralized distribution, intuitive workflows and strong integration with our Training Management module ensure that quality and compliance are at the heart of your operations.
With the SOP Management Module, you can create, review, approve and make effective any quality related document with ease. Built-in version control, unique document numbering, document status management, change control and complete audit trails allow you to be in complete control of your document management process. Integration with our other Quality Connect modules ensures that everyone is properly trained on controlled documents and that quality events can be crossed referenced.
Keep the heart of the quality system beating
Standard Operating Procedures (SOPs) and other controlled quality documents are at the heart of the quality system within life sciences organizations. Ensuring team members have easy access to effective SOPs is critical to ensuring ongoing quality and regulatory requirements are met. SOPs must be managed in a controlled and traceable environment and must be well organized and up-to-date. It’s important to structure your quality documents this way so as to ensure that the correct revision is being used at the correct time for the various regulated processes that we are required to manage in our organizations.
Perfect For
Pharmaceutical Organizations
Contract Research Organizations
Manufacturing Organizations
Built To
Manage the entire lifecycle of controlled documents
Automate quality document review and approval
Easily initiate training on SOPs
Take the tour
All of the tools you need, in one solution
New Document Creation
Create controlled quality documents from templates or upload existing documents directly into SOP Connect
Revise Quality Documents
Electronically manage the revision and review of existing documentation within SOP Connect
Review & Approval Workflows
Reduce document review and approval time with interactive parallel reviews and digital signatures
Automatically Trigger Training
Define training requirements for each document and automate training tasks when they’re updated or revised.
Review Documents Periodically
Easily set periodic review dates to automatically initiate the periodic review process.
Your document control process. Centralized.
Version Control
Automated document versioning allows you to roll back to previous versions while also ensuring that the current version is always being used
Template Management
Centralized template repository allows you to store and centrally publish controlled document templates, ensuring everyone is using the latest template available
Audit Trails
Detailed audit trails and document activity logs allow you to see a full document history including who’s viewed the document and the current document status.
Digital Signatures
Integrated 21 CFR Part 11 compliant digital signatures allow your controlled documents to be signed electronically directly within a workflow task, completely eliminating paper.
Collaborate Simultaneously in one document.
Simultaneously Edit
Strong integration with Microsoft Word means that authors and reviewers can collaborate together on documents and see each other’s edits and comments in real-time.
Real-time Communication
Integration with Microsoft instant messaging Tools such as Skype for Business allows authors and reviewers to communicate with each other interactively from directly within the document or within SOP Connect.
Collaborative Review
All reviewers are able to review the document in parallel and view each other’s comments and changes, significantly reducing review cycles and time
Consolidate & Save
Consolidation of changes and comments has never been easier as everyone is working within the same document. This allows document owners to not only reduce duplicates but also quickly put together the final draft of the document.
Automatically trigger training activities.
Issue training tasks
Once a controlled document has been approved, the system issues training tasks automatically to everyone who needs to be trained based on the centralized training matrix
Automate re-training
Following a revision of a controlled document, the system is able to reissue training tasks to all trainees to make sure that they are trained before the new revision becomes effective
Reduce non-compliance
Training Connect is able to calculate automatically who needs to be trained on which SOPs and can highlight and fill any gaps in real-time
Before implementing SOP Connect Training Connect from Montrium, our process was manual, inefficient, and archaic. Since then, the process has become streamlined, resulting in increased productivity, organization, and positive results through multiple successive audits from various regulatory authorities.
Packed Full of Other Functionality
Lifecycle Workflows
Dynamic and intuitive workflows drive the complete process of controlled document management
Document Versioning
Fully automated document versioning and version history ensures you are always using the latest version
Automatic Reminders
SOP Connect monitors for periodic review to ensure that you don’t miss review deadlines
PDF Generator
Automated PDF/A generation ensures that your quality records are always readable and retrievable
Intelligent Metadata
Intelligent metadata comes preconfigured with the system allowing you to easily identify and view documents in different dimensions
Digital Signatures
Integrated 21 CFR Part 11 digital signatures can be embedded into documents to ensure validity and traceability
Web Application
Montrium Connect is 100% web-based and can be accessed anywhere, anytime with nothing to install on the user’s computer
Template Management
Centralized template management for documents and forms means that everyone is always using the latest template
Email Notifications
Users can receive notifications directly in their inbox providing direct links to documents, forms and tasks