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Polaris can conduct onsite or remote Part 11/CSV audits of the software, infrastructure, and IT services your company relies on, whether at your premises or off-site at a vendor facility. Your audit can be comprehensive, or focus on a particular functional area, business operation, or computer system. We verify compliance with 21 CFR Part 11 and other FDA regulations and guidelines, Good Automated Manufacturing Practice (GAMP), ICH guidances, and Annex 11, if appropriate. We also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, record retention, and problem reporting.
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Polaris can help you with audits concerning:
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