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.
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.
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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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