BioTechnology
A successful risk-based approach to your software development

Comply with frameworks like GAMP 5 and FDA software guidances as you develop software, and empower your regulated engineers with an automated, user-friendly workflow created by our team of experts.

Continuous compliance visibility throughout your
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Capabilities

Grappling with infrastructure

Continuous system evaluations leave teams an overwhelming list of tasks as they maintain digital knowledge continuity: collect data, update software, integrate with team tools, organize data, and redeploy applications to validated systems. However, a lack of framework and inconsistencies in training leave teams in a lurch, slowing development, reducing productivity, and increasing project expenses.

Traceability across IT systems

Software Supply Chain and Open Source

Integrations

Regulated AI/ML

Capabilities

Establish connections. Manage infrastructure.

Integrate Open Source software, data analytics tools, and machine learning libraries into GxP applications

Continuous System Visibility

Complete transparency across your regulated applications

Compliant with IEC 62304, ISO 14971, CFR 21 Part 11

End-to-end GxP compliance visibility across your Software Development Life Cycle (SDLC). Automated workflows, remote audit, and extensive governance features.

Easily connect to your manufacturing systems

Passive and Active Product Surveillance

Compliant with GAMP 5 and relevent FDA guidances

End-to-end GxP compliance visibility across your Software Development Life Cycle (SDLC). Automated workflows, remote audit, and extensive governance features.

Maintain Digital Knowledge Continuity

Understand and categorize each item in your system with simple, readable labels

Trace team actions, keep every team member up to date with the latest data, and follow actionable prompts

Use a self-contained system and lower the barrier for onboarding and teaching new team members

Things that took years can now take weeks or months.
R&D Director, Fortune 500 Biotech Manufacturer
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