Track self-inspections, supplier quality evaluations, and official health authority inspections in a single framework.
Construct yearly audit schedules, define audit scopes, select auditors, and assign tasks with automated notifications.
Log quality findings on-site. Track severity, descriptions, containment actions, and evidence files.
Directly link audit observations to corrective actions. Automatically track CAPA progress through closure.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Schedule recurring audits based on site risk metrics, vendor categories, or regulatory requirements. Manage audit calendars and coordinators.
Construct checklists mapped to regulatory clauses (GMP, GLP, ISO 9001, ISO 13485). Auditors can score checklists directly on tablets.
Log findings instantly, rate severity (Critical, Major, Minor), assign corrective action owners, and attach evidence (images, logs).
Assign lead auditors, define audit groups, set timelines, and track auditor availability across site divisions.
Generate comprehensive audit reports, observation summary tables, compliance scores, and executive summaries with electronic sign-offs.
Monitor audit completion rates, open NC metrics, average resolution times, and compliance score trends by site or department.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Create the audit entry, set dates, assign the lead auditor, define the GxP scope, and select the checklist template.
System alerts target departments or vendors of the audit date, scope, agenda, and request preliminary documentation.
Auditors perform evaluations, filling out checklist questions and uploading notes directly in the software.
Record any findings, categorize severity, log raw observations, and attach supporting evidence records.
The software aggregates checklist scores and observations, formatting the draft report for review and approval.
The audit report is signed by the lead auditor and QA manager using double-factor electronic signatures.
Department heads are assigned NCs, define corrective action plans, submit resolution evidence, and QA closes the audit.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Supplier quality agreements, standard operating procedures, and specifications are retrieved and checked during audits.
Audit team credentials and department training logs are instantly verified by pulling training records from the LMS.
Audit findings automatically trigger CAPA tasks, ensuring a closed-loop resolution pathway.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
No more sorting through paper binders. Instantly pull up history, checklists, findings, and CAPA logs.
Maintains an end-to-end trace from planning and execution, to findings, CAPA, and final signature approvals.
Automated notifications track open observations and keep action owners updated on target deadlines.
Every audit sign-off, observation modification, and report approval is captured in the immutable audit log.
Fully optimized to support critical environments with strict GxP, ISO, or GLP compliance requirements.
We combine cutting-edge software design with rigorous pharmaceutical validation methodologies.
Learn MoreSoftware lifecycle follows GAMP 5 principles to streamline computer system validation requirements.
All evidence files, checklist logs, plans, and reports are protected in a secure cloud repository.
Restrict audit access to authorized internal auditors and regulatory coordinators.
Notifications alert task owners of approaching audit dates and overdue corrective actions.