quality and compliance

Get to market faster with unshakeable quality processes

Trusted by thousands of quality professionals globally

Top quality assurance leaders leverage Montrium to hit their goals

Get oversight on team issues

Gain visibility into your entire team’s activity and drill down into specific processes

Review pending activities and move processes forward

Diagnose exactly what might be impacting timelines

Monitor training advancement and effectiveness

Identify potential training blockers that might affect procedural effectiveness

Ensure documentation is moving forward as planned

Review and prioritize
periodic review of
procedural documentation

Review state of QMS

Plan for upcoming audits
and remediate any
quality issues

Get a holistic view of your global quality system

Address any outstanding activities and tasks

We really wanted a company to partner with who had that experience in our space, who understood the industry that we’re in, and who understood that we’re a small company in the process of growing.

Margaret Farrell

Director of Quality Assurance

Packed with tools for your entire
quality team

Key performance indicator management
Quality system health reporting
Commitment tracking
Global submission planning 
Training compliance & GAPS reporting 
Automated distribution of training tasks 
Curriculum development & onboarding planning 
Proficiency evaluation with multi-choice quizzes 
Template standardization & management
Full version control & integrated audit trails 
Automated workflows for review & approval 
Native integration with Microsoft Office 
Study team training compliance tracking 
Study deviation management & CAPA initiation 
Procedural development and control 
Inspection readiness preparation 

Top resources for quality assurance

White Paper
Clinical Operations
Building a Risk-based TMF Management Framework
In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management. It goes beyond simply explaining the theory behind risk-based approaches to providing worked examples that illustrate how you can implement this model within your own organization.
Clinical Operations
The State of TMF Industry Report 2023
The State of TMF Industry Report 2023 is the largest report of its kind, featuring proprietary data collected from 245 TMF professionals and analyses from Montrium's seasoned experts.
Clinical Operations
Guide to Sponsor vs CRO-owned TMF Systems
Our free guide breaks down the advantages and disadvantages of owning a sponsor eTMF system vs a CRO-owned eTMF system.
Clinical Operations
eTMF Request-for-Information Template
Our free RFI template helps get all of the critical criteria you need to evaluate eTMF software vendors.
Clinical Operations
Guide to Bringing TMF Management In-House
Discover what it takes to get from A-to-Z and manage your TMF internally with our free guide.
Clinical Operations
The Complete Guide to Buying eTMF Software
This guide will help select the right eTMF solution for your team with expert guidance and advice.
Clinical Operations
The Ultimate Checklist for Inspection Readiness
Our TMF checklist will provide you with a clear action plan as you prepare for your inspection.
Clinical Operations
COVID-19 and TMF Management Report 2020
The report includes the results of our COVID-19 and TMF Management Survey, with views representing a wide range of industry stakeholders, including pharmaceutical and biotech sponsors, and CROs.
Regulatory Affairs
The Complete Guide to Buying RIM Systems
This buyer’s guide is designed to help you step-by-step towards selecting the right regulatory EDMS solution and vendor.
GxP Software Vendor Selection Checklist
Not sure where to start when it comes to selecting the right software for your business? Check out this free checklist.
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
Clinical Operations
Template - Paper-based System Cost Calculator
Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics, and in minutes can tell you the total annual cost of your paper-based system.
Quality Assurance
IT SOP Checklist for Life Science Companies
The SOP checklist includes a full list of procedural documents needed, information on their function and purpose, and how to get them in place.
Clinical Operations
eTMF Implementation Planning Workbook
This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation.
White Paper
Quality Assurance
White Paper - 21 CFR Part 11 vs Annex 11
In this guide, we show you how to approach compliance around computerized systems using both directives, as well as how using GAMP 5 can level the playing field.
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