Computer System Validation Montrium
We’re focused on reducing the validation burden
The cost and time associated with validation of GxP computerized systems can represent a significant part of the overall software implementation budget. For many years, Life Sciences companies have been burdened with the cumbersome process of validation, often taking as long as the implementations themselves.Regulatory agencies have recognized this and recommend a risk-based approach to focus validation efforts on high-risk areas and reduce the validation burden whilst improving quality. This approach is at the core of Montrium’s validation service offering.
At Montrium, we employ a risk-based approach to the computer system validation (CSV) process ensuring the right amount of testing and documentation is undertaken. This approach to CSV saves our clients considerable time and money when implementing electronic systems. We have a dedicated team of validation and compliance experts who develop and implement system validation activities based on industry best practices and their significant industry knowledge. Our knowledge of life sciences software and systems is extensive, and can be leveraged in your next implementation project.
Our Validation services can be adapted and tailored to meet your organizational needs, leveraging our extensive document templates library and professional services team. Our knowledge of life sciences software and systems is extensive, and can be leveraged in your next implementation project.
Our team of validation experts will work closely with your QA and IT teams, as well as software vendors to ensure that a coherent validation strategy is implemented in line with quality requirements, available resources and associated risks with the system.
Executing validation testing can represent a significant part of overall effort when it comes to implementing GxP computerized systems. Montrium’s Computer Systems Validation experts are able to hit the ground running and take on all aspects of validation execution.
An essential part of any GxP computerized system validation strategy, is understanding the impact that the system has from a regulatory perspective. Montrium’s Validation Experts have many years of experience performing assessment of various computerized systems against the requirements of 21 CFR Part 11 and Annex 11 in order to demonstrate the compliance of an application with these regulations.
One crucial element of the Validation Planning process is risk assessment. When performing a risk assessment, experience is essential in order to be able to identify risk areas associated with the use of a GxP computerized system. Montrium’s Validation Experts can work with you to create a validation plan that focuses on areas that pose a high regulatory and/or business risk to your organization in order to focus the validation effort, to diminish costs and speed up implementation time.
Montrium’s Validation Experts have developed and executed validation test scripts for the vast majority of computerized systems found in clinical trial and pharmaceutical development, including: CTMS, EDC, EDMS, eCTD, Pharmacovigilance and QMS
Montrium’s expert Professional Services team worked with us to formalize our Standard Operating Procedures (SOPs) and our Master Validation Plan. We also worked closely with their team to validate our network infrastructure and data collection software. Their professional and experienced team ensured that we implemented a strategy that was not only in alignment with our pharmaceutical clients’ requirements but also the relevant regulatory requirements (21 CFR PART 11).