Risk & Financial Advisory

Risk & Financial Advisory

OUR PHILOSOPHY

A Structured Approach to Laboratory Data Integrity

SoftGroup® OneLAB helps laboratories bring analytical instrument data under control through a clear, validated workflow.

From distributing approved methods before analysis to collecting results in a centralized repository, OneLAB supports compliant operations, faster review, and full traceability across regulated environments.

All instrument outputs, sequences, and reports are stored in one secure system – easy to retrieve, review, and share during audits.

OneLAB supports FDA 21 CFR Part 11 and EU Annex 11 requirements with audit trails, controlled access, and electronic signatures.

Designed to reduce manual tasks like logbook maintenance and fragmented file handling, improving productivity without adding complexity.

laboratory data management

Laboratory Data Integrity, Centralized

SoftGroup® OneLAB provides a validated environment for centralized instrument data control across HPLC, GC, and dissolution systems. It ensures secure storage, fast review of results, and full traceability to support compliant laboratory operations.

How SoftGroup OneLAB Works

How SoftGroup® OneLAB Supports Laboratory Workflow

01

Connect Your Instruments

SoftGroup® OneLAB integrates HPLC, GC, and dissolution systems into one controlled environment, preparing instruments with approved methods, sequences, and templates before analysis.

02

Capture Results Centrally

After each run, OneLAB automatically collects output files and stores them in a secure centralized repository, eliminating fragmented workstation storage.

03

Review and Verify with Full Traceability

Lab teams can review results, apply role-based approvals, and maintain complete audit trails with revision history, tracking logs, and e-signature support.

04

Stay Ready for Inspections

SoftGroup® OneLAB ensures laboratory data integrity and compliance with EU Annex 11 and FDA 21 CFR Part 11, accelerating investigations, submissions, and audit preparation.

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