Validation Services
​Whether you are short on time or expertise, we have the experienced software validation project managers and engineers who can get your validation project finished on time.
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System validation projects can pose a significant challenge to employees who have other primary responsibilities. Projects can drag on for months – frustrating both the validation team and management.
Our validation experts focus exclusively on your project – no distractions – to get the validation done quickly. We use the latest risk-based validation approaches, so you can start using your new system soon.
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Or, if you have a legacy system that needs retrospective validation, our experts can promptly remediate the situation, so you don’t get caught in a state of non-compliance.
Our Approach to Computer System Validation Projects
We will ensure that your validation complies with FDA, EMA, MHRA, and other agency regulations:
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Our validation experts bring a standard suite of Software Validation templates, such as the Validation Plan, User Requirements, Validation Protocols, and the Validation Report
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Perform system Risk Assessment
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Develop a Validation Plan that is appropriate for the system risk level
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Work with your team to document User Requirements and Functional Specifications
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Develop Test Plans and Deliver Validation Protocols (i.e., IQ, OQ, PQ)
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Execute the Validation Protocols and provide supporting test documentation
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Deliver inspections ready Test Summary and Validation Report
Our validation professionals can work with you either at your site or remotely – whichever fits your needs and budget.
Outsource your next Validation Project or your entire Validation Program
By leveraging our experience, you can:
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Significantly reduce the timeline to a ‘validated state; We bring the methods, templates, and trained professionals
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Have the confidence that your validation documentation is inspection ready
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Utilize your employees’ time to focus on what they do best, rather than struggling with CSV
Our outsourcing experience includes Cloud-based, COTS, SaaS and Custom Applications:
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Cloud-based (SaaS and PaaS) applications
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Configured Off-the-Shelf (COTS) applications)
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On prem and cloud-based (IaaS) infrastructure
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Initial validation, retrospective validation, and ongoing validation for software updates