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Data Integrity (DI) Consulting |
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Top-Down DI auditing and analysis of DI governance,
Bottom-Up forensic DI investigation and analysis, 21 CFR Part 11
Electronic Records and Electronic Signatures validation and more. |
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Quality System Consulting |
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Fuller Compliance offers Quality System
consulting – including Complaints, CAPA, Risk Analysis,
Service Issue Analysis, Outside Audit and more. |
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Audits – internal quality system
audits |
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Internal quality system audits can be conducted
on all or part of the company’s quality system, and
can document current compliance to company SOPs (Standard
Operating Procedures), or the need for improvement. |
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Audits – external supplier audits |
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Vendor / Supplier audits can be performed
to document supplier conformance to customer specifications,
government regulations, contract agreements, or other as specified |
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Audit/Inspection preparation
[pre-audit] |
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Pre-Audits are conducted to assure management
that the organization will successfully pass an upcoming audit
or inspection, or will highlight areas in need of improvement
prior to the inspection or audit. |
