EXTERNAL AUDIT MANAGEMENT

Managing audits is said by most Medical Device manufacturers, suppliers, distributors, and auditors to be their number one frustration alongside becoming certified, and maintaining continued compliance.

The complexity of conducting and hosting audits is compounded by several factors including:

  • The constantly-changing regulatory requirements
  • Lack of efficient audit management strategies and tools
  • Demanding nature of audit follow-ups
  • Differences in the working style of auditors
  • Vertical nature of  external audit requests (audit trails)
  • Several auditor requests being followed up simultaneously
  • Insufficient number of staff to handle auditor’s requests

AuditMan takes the stress out of external audits by:

  • Strategic preparation
  • Effective audit request management
  • Facilitating fetching audit evidence
  • Simplifying audit non-conformance follow-ups
  • CAPA and Complaints Tracking
  • Having all QMS documents at your fingertips during audits
  • Comprehensive data for reporting to top management

AuditMan offers companies successful External Audits by:

  • Workflow automation for request management
  • Real-time request status tracking
  • Pre-audit preparation to minimise audit stress and fatigue
  • Responding to audit nonconformances, fast and efficient
  • User access control and permissions
  • Customisable In-Platform and Email notification
  • Effective communication between the audit room and back rooms
  • Private communications under each audit request (hidden from auditors)
  • Audit scribe function (audit logs and notes)
  • Audit evidence sharing via the most-secure cloud system (AWS)
  • Audit history, archiving, and management summaries
  • 1-click audit summary report generation for top management

External Audits

AuditMan takes the stress out of external audits by:
  • Strategic preparation
  • Effective audit request management
  • Facilitating fetching audit evidence
  • Simplifying audit non-conformance follow-ups
  • CAPA and Complaints Tracking
  • Having all QMS documents at your fingertips during audits
  • Comprehensive data for reporting to top management