validation services

Validation in Montrium

Validation is required for regulated content management systems like Connect because the content stored on the platform needs to meet the requirements set forth by regulations for audit trails, electronic records, electronic signatures, and security.  

Montrium’s in-house validation team assists all subscribers with the management and execution of their computer system validation responsibilities, optimizing the process to relieve part of the validation burden.

Validation methodology

Montrium’s tried and tested validation methodology leverages industry best practices and standards for computer system validation to ensure all of our products meet current regulations under FDA 21 CFR Part 11 and EU Volume 4 Annex 11.

To optimize the validation portion of the implementation process further and save you time, money, and stress – our recommended approach to qualification, testing, and validation aligns with GxP industry standards and best practices for pain-free validation processes.

Leveraging Montrium’s internal testing and qualification can help reduce the time and effort that is required to complete validation on your end.

Comprehensive validation pack

To maximize significant savings of validation costs, Montrium provides a validation template package for each major release of the Connect product. Our methodology significantly reduces the time and resources you need to invest in the validation process, allowing your organization to quickly adopt the newest and most innovative technologies within the life sciences industry.

Validation plan template

Accelerate your validation process with our pre-completed validation plan template that allows your team to demonstrate that the Montrium application you’re implementing meets the regulatory requirements.

Validation summary report

Sleep easy at night knowing that all of your verification activities are well documented and get a head start with our Validation Summary Report template.

Statement of compliance

Build confidence in an audit or inspection with a comprehensive compliance statement outlining all of the controls and processes Montrium has in place to comply with the regulatory requirements.

Business requirements template

Level the playing field with a comprehensive business requirements template that’s based on the functionality of the application you’re implementing.

Validation test protocols & scripts

There’s nothing more frustrating than trying to develop validation test scripts for a system you’re not that familiar with. We lighten the load and provide you with an extensive list of test scripts based on the functionality that you’ll be using in an effort to streamline the verification step.

Requirements traceability matrix

Leverage our pre-built Requirements Traceability Matrix to map your business requirements with your testing plans.

We have been extremely pleased with the guidance that we are being provided. We understood that it would be very important for us to find a platform that could grow with us as we progressed into Phase III.

Kimberly Swint

Manager of Clinical Trials Documentation

Benefits of Montrium’s validation approach

Industry experts, validation specialists and most importantly, the regulators, are calling for systematic industry adoption of risk-based approaches to validation.

Unlike traditional validation methodologies, ‘risk-based’ allows you to validate and verify that the system meets its intended use in different ways. All the while keeping a keen eye on the areas of the system that post the greatest risk to product quality and patient safety.  There are a number of benefits to Montrium’s approach to computer system validation:

Alignment to industry best-practices & standards

Risk-based approach to computerized system validation is now a regulatory recommendation. Don’t get left in the past.

Reduced validation costs

When we take a risk-based approach, this significantly reduces the cost and delay that traditional validation often brings.

Minimal validation resources required

Because you’re levering a wealth of existing testing and validation from Montrium, your teams can focus on what validation effort is left and other core business tasks.

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