Comprehensive Internal Audits, gap analysis and Quality System implementation.
Quality Management Systems
Auditor certified to and experienced with Standards audited
Records of certification and experience available
Audits conducted onsite, remote or hybrid
Internal Audits
Audits are scheduled for one day or several, based on the number of employees, processes to be audited, and regulatory requirements. The Audit report will provide a summary and details of findings found during the audit. The report is delivered within one week of audit completion.
Quality Management System Implementation
Establishment of QMS documentation to comply with the standard and or regulations. Assistance with actions arising from third-party audits, corrective actions, and quality objectives.
Gap Analysis
Full system process audit, audit plan, and comprehensive report of findings. All findings are observations and do not require documented corrective action. Report delivered within one week after audit performed.
Documentation Assistance
Guidance on setting up a document and record control system. Concentration in document identification, creation and approval, distribution, revision control, retrieval and accessibility, retention, and disposal. Custom flowcharts and data analytics to visualize process.
Regulatory Compliance
Guidance with QMS Regulatory requirements for FDA (21 CFR Part 820), FDA QSMR (21 CFR Part 820 alignment with ISO 13485 in 2026), EU MDR Medical Device Regulation, IVDR in Vitro Diagnostic Regulation and Finished Pharmaceuticals (FDA 21 CFR Part 210 and 211)
