CSV & CSA Programs
Set your validation projects up for success from the start. Our consultants apply proven methodologies for computer system compliance and equip your team with the latest Computer System Validation (CSV) and Computer Software Assurance (CSA) practices.
Building a program internally can take months of research, benchmarking, and developing SOPs and templates—often pulling key staff away from their core responsibilities.
With MAP Tech’s CSV and SQA experts, you can accelerate the process, implementing a robust, compliant validation framework in just weeks—on par with the industry’s most experienced competitors.
Our Approach to Implementing a Compliant CSV & CSA Program
Realize Results with an Effective CSV & CSA Program
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Faster implementation of a compliant validation methodology and SQA processes.
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Confidence in compliance, with an approach designed to withstand regulatory inspections and customer audits.
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Empowered staff trained in best practices and equipped to manage future validations successfully.
We implement Computer System Validation (CSV) and Computer Software Assurance (CSA) programs that align with FDA requirements, EU expectations, and industry best practices, using a practical and risk-based methodology:
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Provide a complete suite of Software Quality Assurance (SQA) SOPs, including Risk-Based Validation, Change Control, Incident Management, and Internal Audits.
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Tailor these SOPs to integrate seamlessly with your existing SDLC, QMS, and technologies.
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Deliver standardized Validation Templates—Validation Plan, Risk Assessment, User Requirements, Test Protocols, and Validation Report.
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Train your staff to effectively apply the SOPs and templates.
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Offer hands-on support throughout your first validation project.