eTMF, eQMS & RIM Pricing Plans

eTMF Connect

Essentials

All the eTMF tech features you need, nothing you don't

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100GB storage included
Up to 10 users

ESSENTIALS includes:

TMF Document Management
Intuitive QC workflow
Built-in TMF Archive
Document placeholders
Batch upload & indexing
Aligned to TMF Reference Model
Built-in Reports
EU or NA hosting included
SSO Support

eTMF Connect

Growth

Enterprise-grade eTMF tech with simple UI for your growing team

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200GB storage included
No user limit

Everything in ESSENTIALS +

Fully customizable workflows
21 CFR Part 11 Electronic Signatures
Document Collaboration with Microsoft Word
Expanded reports library
Document template center
Premium customer support
Placeholder & index management
Dedicated Customer Success Manager

Add-On

Risk Management and oversight

Know where your risk sits, then show exactly how you reviewed it.

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Risk Management

Risk score per study, across 5 dimensions
Configurable issue-type weighting, logged before and after
Flags weak or missing records before an inspection does

Study Oversight

Scope reviews by risk signal: site, country, process zone, document type
Assign reviewers, capture pass or fail decisions, raise queries
Automatic evidence capture built into your review workflow

Quality Management System

Quality Connect

Scale quality processes to prepare for growth.

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+ Document Control Module

Automated workflows
Template management
Review & approvals
Word integration
Records archiving center
Electronic signatures
PDF conversion
Reports & KPIs

+ Training Management Module

Training matrix
Template management
Task automation
Training courses
Training quizzes
Gaps reports
KPIs & metrics
E-Learning content

+ Supplier Management Module

Supplier Onboarding
Supplier Management Automation
Periodic Assessments of Suppliers
Suppier Record Storage

+ Audit Management Module

Observation Management
Audit Schedules
Task & reminder notifications
Reporting & KPIs

+ CAPA & Quality Events Module

Quality Event Reporting
(Deviations, Complaints, Incidents etc)
Automated workflows
Task & reminder notifications
Reporting & KPIs
Action creation/tracking
Root cause analysis
Investigation management

+ Change Control Module

Automated workflows
Template management
Review & approvals
Word integration
Records archiving center
Electronic signatures
PDF conversion
Reports & KPIs

Regulatory Information Management Plaform

RegDocs Connect

The RIM platform built for leaner regulatory teams

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100GB of storage
Low monthly user fee
Unlimited products and submissions
One-time activation fee

Functionality included

Regulatory authoring
Customizable document workflows
Submission & sequence planning
Correspondence & commitment management
Regulatory submissions archive
Product information tracking
Document collaboration with Microsoft Word
Submission readiness reporting
Version control & audit trails
Document template center
Aligned and exportable in eCTD format
21 CFR Part 11 Electronic Signatures
PDF/A conversion engine

Adobe Acrobat Sign Validation

free validation pack

Accelerate the validation of Adobe Acrobat Sign following a risk based approach

Download pack

Full validation package for Adobe Acrobat Sign
Developed by Montrium
Leading validation methodology
Available for free

Accelerator Toolkit Includes

Validation plan
Regulatory Impact Assessment
System Requirements Specification
Validation Test Protocols & Scripts
Executed Test Scripts Summary Report
Work Instruction - Adobe Administration

Adobe Acrobat Sign Validation

Continuous validation

Continuous validation support as Adobe makes releases

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Endorsed by Adobe
Validate in as little as 2 weeks
Ensure Adobe Acrobat Sign remains validated
Mapped to Adobe's release schedule
Ongoing software assurance subscription
Full documentation package
Leading validation methodology

Continuous Validation Subscription includes

Adobe Vendor Assessment
Based on SOC2 Type 2 Reports produced by independent 3rd party auditors
Validation Summary Report & Ongoing Documentation Updates
Describing how the validation package from Adobe and test scripts executed by Montrium have been leveraged, with updates maintained across Adobe releases
Configuration & Functional Verification Test Execution
Execution of configuration and functional verification test scripts across major Adobe releases
Expert-Led Change Impact Evaluation
Access to Montrium's validation experts to assess the impact of Adobe releases
Electronic Signature Policy
Policy template that can be adapted internally to your company
Employee ID Verification & Non-Repudiation Form
Template that can be adapted internally to your company format
eSignature Notification for Health Authorities
eSignature notification for regulatory authorities