Overview

Arcondis’ GxP Lifecycle Automation service transforms validation in life sciences by streamlining processes, significantly reducing manual effort, and ensuring compliance with global regulatory standards. Seamlessly integrated with client-preferred tools, it accelerates product releases and supports continuous audit readiness.

Your Business Challenge

Life Sciences organisations face significant hurdles with traditional Computer System Validation (CSV).

• Manual Workloads Delay Progress. Do your teams spend excessive time drafting, reviewing, and approving validation documents? Your core platforms – such as JIRA, Azure DevOps, Jenkins, ValGenesis and others – often function in isolation, creating fragmented workflows and delays in system implementation and updates.
• Poor Documentation Weakens Compliance. Do you have inconsistent document structures and limited version control that make it difficult to maintain traceability, increasing the risk of findings during audits and inspections.
• Validation Delays Drive Up Costs. Are you experiencing extended testing cycles and reactive documentation updates that inflate operational overheads, reduce responsiveness and limit the ability to scale innovation.

These challenges affect more than just quality – they delay product launches, strain compliance resources, and reduce competitive advantage.

How We Can Help

We offer a modular, scalable service that adapts to your validation maturity and system landscape.

• Transforming how validation is done by reducing documentation and approval gates.
• We provide templates and tools to support seamless integration with platforms like JIRA, Azure DevOps, GitHub, Jenkins, ValGenesis, and more.
• Full alignment with global regulatory frameworks, including FDA 21 CFR Part 11, EU Annex 11/15, ISO 13485, and ISO 27001, and more.
• Available as a Managed Service, Hybrid, or SaaS model.

Arcondis brings together CSV specialists, DevOps architects, engineers, and quality experts to deliver a service that fits into your organisation – not the other way around.

Your Business Benefits

• Shorter Timelines. A substantial reduction in validation timelines, including a decrease in document creation time and faster system implementations. Documentation generation can be fully automated and run at any time in an automated pipeline.
• Reduced Cost. You will benefit from significantly reduced validation costs, resulting in average significant savings per enterprise system validation.
• Increased Productivity. Enhanced operational impact, that includes an improvement in document traceability and a reduction in time spent locating validation documents.
• Increased Test Accuracy. The quality and compliance outcomes are impressive, with less document-related errors, a decrease in audit findings and an increase in test execution accuracy.
• Significant Impact On ROI. These benefits result in a higher return on investment.