Stay on top of internal, supplier, and regulatory audits with a connected system built for life sciences compliance. Plan, track, and close audits confidently – without spreadsheets or surprises.
Stay on top of internal, supplier, and regulatory audits with a connected system built for life sciences compliance. Plan, track, and close audits confidently – without spreadsheets or surprises.
In life sciences, Audit Management is critical to maintaining a compliant, inspection-ready operation. Whether you’re managing internal audits, supplier audits, or facing regulatory inspections (FDA, EMA, ISO), you need a structured and traceable process.
Schedule internal, external, and regulatory audits with ease.
Standardize audit execution with templates and checklists.
Meet FDA, ISO 13485, GxP, EU Annex 11, and other global standards.
Build audit schedules and assign responsibilities with full visibility and reminders
Link audit observations to CAPAs, deviations, or quality events automatically
Capture findings, responses, and approvals with secure, compliant audit trails
Designed for 21 CFR Part 11, GxP, ISO 13485, and other industry standards
Monitor audit status, overdue actions, and trends across sites or teams
Use audit insights to proactively identify risks and improve processes
Design your audit workflows, forms, and routing rules – no IT help needed
Built by QA professionals who understand FDA, GxP, and ISO expectations
Highlight recurring findings, overdue actions, and at-risk areas.
A modern eQMS that scales from fast-growing biotech to global pharma and medical device.
Leverage the power of ServiceNow, the world’s leading digital workflow platform, for seamless integration, automation, and enterprise-wide visibility.
Maintain full audit trails, validation, and 21 CFR Part 11–compliant eSignatures
Build audit calendars by site, department, or vendor with recurring reminders.
Use consistent templates and capture evidence during the audit process.
Log observations with severity levels, impacted processes, and supporting files.
Open corrective or preventive actions right from the audit record.
Pull reports instantly and demonstrate compliance with FDA and ISO standards.
