Design, Develop & Maintain Standard Operating Procedures (SOP)
ReliSource has proven experience in Validation & Regulatory Compliance for Clinical Trial Industry in the following areas:
- Design, Develop & Maintain Standard Operating Procedures (SOP)
- Compliance with cGMP (GAMP-5) and other standards (FDA 21 CFR Part 11 and HIPAA)
- Perform System Qualification & Validation: CC, IQ / OQ, PQ, Audit Trail Reports
- Audit: External Audit-Ready; External Audit Dispute Resolution
- Tools Used: SysAid, DocuSign, Box, JAMA, Confluence, JIRA, Bitbucket, ComplianceWire, Cornerstone, etc.
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