GxP Compliance & Quality Assurance

Digitized GxP Compliance: Audit-Ready, Always

Replace error-prone paper logbooks with a secure, digital quality management system. AuditDAT enforces strict GMP, GLP, and GDP standards across your facilities—and our "Done-for-You" onboarding means your Quality Assurance team never has to waste time building digital forms.

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Paper-Based Quality Assurance is a Threat to Data Integrity

In highly regulated industries, a single missing signature, lost document, or illegible logbook entry can trigger severe regulatory findings, product recalls, or production halts. You need verifiable data integrity, but transitioning to digital can't disrupt your daily operations.

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The Risk of DIY Systems

Competitor applications force your highly-paid Quality Assurance team to become software developers, spending months building and validating complex digital forms just to get started.

The UPDAT Solution

Send us your strict SOPs, cleaning logs, and inspection records. Our team digitizes and maps them into AuditDAT for you, deploying a compliant, ready-to-use system that meets ALCOA+ data integrity principles from day one.

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Uncompromising Data Integrity (ALCOA+)

Ensure every piece of quality data collected on the shop floor or in the lab is Attributable, Legible, Contemporaneous, Original, and Accurate.

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Traceable Approvals

Mandate digital signatures, user-specific logins, and mandatory photo evidence for critical quality checks.

Unalterable Audit Trails

Every entry, modification, and completed task is permanently logged with an uneditable timestamp, ensuring complete transparency for regulators.

Version Control

Instantly push updated SOPs and regulatory frameworks to all mobile devices, ensuring your team is never using an outdated checklist.

Automated CAPA (Corrective & Preventive Actions)

When a deviation occurs on the production line, speed is critical. AuditDAT turns your quality checks into an active defense system.

Instant Deviation Routing

A failed quality check or out-of-spec reading instantly triggers an "Action," immediately notifying QA management and assigning a corrective task.

Closed-Loop Resolution

Track every deviation from the initial flag to root-cause analysis and final QA sign-off, completely digitizing your CAPA workflow.

Mobile Line Clearances & Equipment Logs

Empower operators to complete pre-production checks, batch records, and cleaning validations directly from mobile devices or tablets without leaving the cleanroom or production floor.

QR-Code Asset Verification

Operators scan a machine or workstation’s QR code to instantly pull up its specific cleaning protocol, calibration status, and recent usage history.

Smart Branching Logic

If an operator notes a machine is out of calibration, the app dynamically adapts, prompting the necessary lock-out/tag-out or maintenance procedures.

Real-Time Inspection Readiness

Whether you are facing an unannounced inspection from the EMA, FDA, or local regulators like the MCCAA, you need answers in seconds.

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Live Quality Dashboards

Monitor compliance health across multiple production lines, labs, or distribution centers in real time.

One-Click Batch Reporting

Generate comprehensive, branded PDF or CSV quality reports instantly, proving compliance without spending days digging through physical archives.

Take full control of your inspections today

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