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