Plan, Execute, and Track Every Audit with Complete Confidence.
Connected Audit Management Across the Quality Lifecycle
OneQMS Audit Management Software helps pharmaceutical, biotechnology, CRO, CDMO, medical device, and other regulated organizations plan, conduct, document, and close internal audits, supplier audits, and regulatory audits through a structured and traceable process. From audit scheduling and preparation to observations, findings, corrective actions, and closure, every stage of the audit lifecycle is managed within a single connected platform.
Each Audit record brings together the information required to manage the audit effectively, including audit scope, objectives, schedule, auditors, auditees, checklists, observations, findings, supporting evidence, responses, and closure activities. Risk-based audit planning and configurable workflows help quality teams establish consistent audit processes while maintaining clear ownership and visibility throughout each audit.
OneQMS connects Audit Findings with related CAPAs, Deviations, Change Controls, Documents, Training, Complaints, OOS, OOT, Incidents, and Quality Events, allowing teams to move seamlessly from identifying a finding to managing its resolution. Automated notifications, task assignments, due date tracking, approvals, and escalation workflows help ensure audit actions remain visible and are completed within defined timelines.
Built for organizations operating under GMP, GxP, FDA 21 CFR Part 11, and EU Annex 11 requirements, OneQMS enables quality, compliance, regulatory, manufacturing, and operations teams to maintain controlled audit records, strengthen audit traceability, and support continuous inspection readiness.
Whether you are looking for Audit Management Software, Internal Audit Management Software, Supplier Audit Software, Regulatory Audit Software, Pharmaceutical Audit Management Software, or an integrated eQMS, OneQMS provides a secure, cloud-based platform that streamlines audit planning and execution, improves finding management, strengthens compliance, and provides complete visibility from audit initiation through closure.
Key Capabilities
Risk-Based Audit Planning
Develop structured audit programs and schedules based on organizational priorities and risk considerations. Plan upcoming audits while maintaining visibility into planned, ongoing, and completed activities.
Efficient Audit Execution
Provide auditors with a centralized workspace to manage audit details, checklists, observations, evidence, and findings, helping standardize how audits are conducted across sites, departments, and suppliers.
Finding and Observation Management
Capture audit observations and findings with supporting information, assign responsible owners, establish target dates, and monitor progress until the required actions are completed.
Connected Corrective Actions
Connect audit findings with CAPAs and other relevant quality processes so that identified issues can move into appropriate investigation and resolution workflows without losing their audit context.
Supplier and Internal Audit Management
Manage different audit types, including internal audits, supplier audits, and regulatory audits, within a common platform while maintaining the specific information and workflows required for each audit.
Inspection Readiness
Maintain organized audit records, evidence, findings, actions, approvals, and historical activity in one controlled environment. This enables quality teams to demonstrate audit history and retrieve supporting records efficiently during inspections.
Key Features
Audit Lifecycle Management
Manage audits from planning and scheduling through execution, findings, actions, review, and closure.
Risk-Based Audit Planning
Build audit programs based on defined schedules, priorities, risk considerations, and organizational requirements.
Audit Scheduling
Plan upcoming audits, assign timelines, and coordinate auditors and auditees from a centralized system.
Audit Checklists
Create and manage structured checklists to support consistent audit execution and assessment.
Observation and Finding Management
Capture observations, classify findings, document evidence, and assign follow-up actions.
Audit Finding Tracking
Monitor finding status, responsible owners, target dates, responses, and resolution activities.
Corrective Action Management
Link findings to CAPAs and other quality processes to ensure identified issues are appropriately addressed.
Automated Notifications and Escalations
Keep auditors and responsible teams informed about assignments, deadlines, and overdue activities.
Electronic Reviews and Approvals
Route audit records, findings, responses, and closure activities through configurable approval workflows.
Complete Audit Trail
Maintain a detailed history of audit activities, findings, decisions, changes, reviews, and approvals.