Our risk-based validation services are designed to meet industry standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. We offer customizable templates and tailored packages, following the CSA (Computer Software Assurance) methodology. Our validation services extend to Cloud SaaS systems, ensuring compliance and audit readiness with specific steps for SaaS users.
Tech Qualitas provides deep expertise in regulatory compliance across various standards:
Ensuring compliance for Electronic Records and Electronic Signatures.
Managing computerized-systems to meet high-quality standards.
Meeting European IT system compliance requirements.
Ensure data integrity and privacy
Our audit services cover a wide range of areas including
We provide detailed assessments to ensure compliance with industry regulations and standards.
We conduct thorough gap analyses and ensure compliance of your quality systems with major regulatory guidelines such as:
Following audits, we offer comprehensive remediation services, including:
Our aim is to ensure that all regulatory issues are effectively resolved and that compliance is maintained.
With decades of experience and a commitment to regulatory excellence, Tech Qualitas offers comprehensive compliance services that help your organization meet industry standards while enhancing operational efficiency. From risk-based validation to audit remediation and cutting-edge IT practices, our solutions are designed to ensure your systems and processes are compliant and effective.
Reach out to us today to discover how we can help!
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