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Enterprise Layer Intelligence
Categories/Healthcare & Life Sciences/Sware
Sware

Sware

Founded 2015

Automate and manage GxP validation processes for life sciences applications and equipment

Pricing model

Demo

You can use Sware to manage life sciences compliance and validation across your applications, equipment, and medical devices. It automates testing and verification workflows while maintaining an audit trail for regulatory standards like 21 CFR Part 11 and EU Annex 11. Teams can track software changes continuously, validate machine learning models with explainable records, and manage equipment calibration. The system integrates directly with developer pipelines, allowing engineering teams to ship updates rapidly without losing regulatory oversight or creating paper-heavy documentation.

What Sware does

Generate computerized system validation documentationTrack system changes and maintain electronic audit trailsExecute automated test protocols for software updatesManage equipment calibration and maintenance recordsVerify compliance with life sciences regulationsGrant secure inspection access to regulatory auditorsValidate machine learning models for regulated clinical workflowsAutomated GxP validation for continuous software releasesAudit trail tracking for 21 CFR Part 11 and EU Annex 11 complianceIntegration of validation checks directly into developer CI/CD pipelinesValidation management for artificial intelligence and machine learning modelsUnified tracking for plant, equipment, and calibration recordsPrebuilt compliance templates to standardize validation workflowsControlled auditor access portals for external and internal inspections

Pricing breakdown

Pricing model: Book a demo

Frequently asked

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