Quality & Regulatory Compliance Audit Software

(Internal and Supplier Audits)

InfoAudit Internal and Supplier Audit Software helps you manage and prepare audit plans, conduct internal, vendor or 3rd Party audits, and monitor and implement the resultant corrective action. It has built-in audit checklists for commonly used standards , such as FDA's GMP, QSR, GTP, and Part 11 regulations; and ISO 9000 and ISO 13485 standards. You can set up a master schedule of all your audits, and then it tracks and alerts you to the upcoming and overdue audits. It provides audit templates and generates audit reports.

General

• Comes with a certificate of Part 11 compliance and validation and with on-site installation/validation documents
• Long and impressive list of powerful features, many of them exclusive to InfoAudit
• Extensive workflow logic

Regulatory Compliance

• Comply with FDA’s GMP/QSR regulations.
• Comply with European Union’s Medical Device Directives (MDD).
• Meet the requirements of international quality standards such as ISO 9000 and ISO 13485.

Quality Tracking

• Identify gaps in quality system implementation
• Initiate, assign, and follow through on corrective actions
• Provide quality feedback to management