Data Integrity (DI) Consulting
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.
Quality System Consulting
Fuller Compliance offers Quality System consulting – including Complaints, CAPA, Risk Analysis, Service Issue Analysis, Outside Audit and more.
Audits – internal quality system audits
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.
Audits – external supplier audits
Vendor / Supplier audits can be performed to document supplier conformance to customer specifications, government regulations, contract agreements, or other as specified
Audit/Inspection preparation
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.