Regulatory Compliance: Achieve & Demonstrate Lab Excellence

Optimize, Modernize & Scale–Without Regulatory Friction

COMPLIANCE BY DESIGN

How It Works

Simplified Regulatory Compliance

Labbit takes the burden out of compliance by embedding it directly into workflows. As work happens, Labbit captures every action to generate complete, immutable audit trails. It tracks every configuration change, helping quality teams quickly understand impact and streamline system revalidation where necessary.

Lab Compliance Features

Move Beyond Spreadsheets, Siloed Data & Paper-Based Systems

Automated
Enforcement

Ensure consistent
adherence to compliance processes

Embed SOPs, approval workflows, and 21CFR Part 11-aligned eSignatures directly into workflows to reduce manual oversight and ensure steps are executed properly and in accordance with industry regulations.

Complete
Traceability

Immutably track
every action in detailed
audit trails

Labbit’s graph-based platform automatically captures all data and relationships as work happens, producing complete, audit-ready records to simplify regulatory submissions and audits.

CoNFIGURATION CHANGE HISTORY

Modernize and
innovate without
validation headaches

Labbit tracks configuration change histories, enabling quality and validation teams to quickly assess the impact of changes and determine the necessary level of revalidation, eliminating unnecessary work and accelerating system updates.

Secure Data
Management

Protect sensitive
data with built-in
security

Data in Labbit is encrypted, stored securely, and only accessible to authorized users, in compliance with SOC2 Type II standards or framework, ensuring privacy and compliance.

Why Labs Trust Labbit For Regulatory Compliance

Ensure Accuracy, Streamline Audits & Stay Compliant

With Labbit, you can:

Design workflows that enforce consistency and reduce the risk of errors.

Easily demonstrate traceability with automated audit trails that capture every action and result.

Accelerate system updates with configuration change histories that enable smarter revalidation.

"With Labbit, all your data and metadata are captured in one place, and audit trails are ready to go, making compliance easy so you can focus on what really matters —delivering quality work instead of chasing paperwork."

- Brian JacK

GM, Professional Services, Semaphore Solutions

Insights & Resources For Modern Labs

Explore our resources & discover how Labbit can help you transform your lab.

Why eSignatures Matter for Regulatory Compliance and What 21 CFR Part 11 Really Requires

min read

Beyond Relational: How Graph Databases Transform FDA-Regulated Recordkeeping

min read

Thinking About System Validation?

Ensuring your lab automation system meets compliance standards requires a clear understanding of IQ, OQ, CQ, and PQ. A well-structured validation process minimizes risks, enhances reliability, and keeps your operations running smoothly.

Learn more

Why Is Regulatory Compliance Important For Laboratories?

Compliance is critical in laboratory environments to ensure that testing and data handling meet legal, ethical, and quality standards. Regulations like GxP, CAP/CLIA, FDA and ISO are designed to protect patient safety, maintain scientific integrity, and guarantee traceability across all lab operations.

Failure to comply can lead to failed audits, reputational damage, financial penalties, or even suspension of operations. Beyond meeting external requirements, strong compliance processes foster internal accountability, reduce risk, and support the delivery of reliable, high-quality results.

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Regulatory Compliance: Frequently Asked Questions

How Does Labbit Improve Audit Readiness?

Labbit automatically records every action in a secure, immutable audit trail. It also generates compliant reports, making it easy to demonstrate traceability, data accuracy, and adherence to regulatory standards during inspections.

Can Labbit Be Configured To Fit Our SOPs?

Yes. Labbit’s workflows are configurable to reflect your lab’s unique standard operating procedures, ensuring that every step is followed correctly and consistently, without manual oversight.

Is Labbit Compliant With Industry Data Security Standards?

Absolutely. Labbit is designed with built-in security and complies with SOC 2 Type II standards. All sensitive data is encrypted, access-controlled, and stored securely.

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