eCDMS
E-Clinical Data Management System
E-Clinical Data Management System
E-Clinical Data Management System is a comprehensive suite of application to manage the entire Volunteer’s record. The software is mainly used for Management of Volunteer’s record encompassing standard operating procedure, regulations, guidelines and any other training.
Centralized control on rights of different based on profile/roles.
Our Expertise Includes:
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Computer System Validation (CSV): Compliance with FDA 21 CFR Part 11, GAMP 5, and other industry standards.
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Equipment & Process Validation: Ensuring operational efficiency and regulatory adherence.
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Software & Application Validation: Verification and qualification of critical software solutions.
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Data Integrity & Compliance Audits: Assessing and mitigating risks to maintain regulatory compliance.
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Qualification Services: IQ, OQ, PQ execution for laboratory, manufacturing, and IT systems.
