Lab Knowledge Base

In-depth guides for lab digitization, IT infrastructure, and regulatory compliance.

Method version control for laboratories: managing SOP changes without losing traceability

How laboratories can manage method and SOP version changes without losing traceability, reviewability, or training control.

Labs

Instrument calibration and maintenance tracking in ISO 17025 labs

What good calibration and maintenance tracking looks like in ISO 17025 labs, from schedules and evidence to traceability and audit readiness.

Labs

CAPA workflows in laboratory software: from deviation to verified closure

How laboratory software should support CAPA workflows, from deviation logging and investigation through corrective action and verified closure.

Labs

Audit-Ready Lab Software: What It Actually Needs

The practical capabilities audit-ready lab software needs, from permissions and audit trails to validation support, traceability, and review workflows.

Labs

Digital Traceability in ISO 17025 Labs

What digital traceability means in ISO 17025 labs, and how to design systems that preserve sample, method, instrument, and result history.

Labs

ISO 15189 and Software Validation: What Labs Need to Know

Understanding the software validation requirements of ISO 15189:2022 and how to implement them efficiently in your laboratory.

Labs

Lab Standards and Certifications: A Complete Overview

A reference guide to the most important standards and certifications for laboratories - IVDR, IEC 62304, ISO 17025, ISO 15189, and more.

Labs

LIMS Implementation Guide for Small and Mid-Size Laboratories

Step-by-step guide to implementing a Laboratory Information Management System in small and mid-size labs without disrupting daily operations.

Labs

Building Regulated Software for IVD Laboratories

Key architectural and process considerations when developing software that must comply with EU IVDR and IEC 62304 for in-vitro diagnostic use.

Labs

Lab Data Integrity: Implementing ALCOA+ in Digital Systems

How to apply ALCOA+ data integrity principles in laboratory information systems, from audit trails to electronic signatures.

Labs

ISO 17025 Software Requirements: Validating Your LIMS and Lab Tools

How ISO/IEC 17025:2017 handles software validation, data integrity, and electronic records in testing and calibration laboratories.

Labs

Electronic Lab Notebooks: How to Choose the Right ELN for Your Lab

A practical comparison guide for selecting an Electronic Lab Notebook that fits your laboratory workflows, compliance needs, and budget.

Labs

Digitizing Your Lab: Where to Start

Practical guidance for laboratories beginning their digital transformation journey - from paper-based processes to a connected lab environment.

Labs

ISO 17025 Accreditation: A Practical Guide for Testing Labs

What testing and calibration laboratories need to know about ISO/IEC 17025:2017 accreditation - from management requirements to technical competence.

Labs

Data Migration from Paper to LIMS: A Practical Strategy

How to plan and execute data migration from paper-based laboratory records to a LIMS without losing data integrity or regulatory compliance.

Labs
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