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.
Our Computer System Validation Services
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.
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Our Computer System Validation services include…
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.
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).
