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Life Sciences & Pharma

Life sciences software must meet stringent validation requirements — AI-generated code needs rigorous documentation and quality controls.

Compliance Requirements

GxP

Meet Good Practice regulations across manufacturing, laboratory, and clinical operations.

GAMP 5

Follow Good Automated Manufacturing Practice guidelines for computerized systems.

EU Annex 11

Comply with European regulations for computerized systems in pharmaceutical manufacturing.

How Supernal Coding Helps

Supports computer system validation (CSV) requirements

Maintains 21 CFR Part 11 compliant audit trails

Documents AI-generated code for regulatory submissions

Accelerates validation lifecycle management

Examples

Clinical trial management

Manufacturing execution systems

Regulatory submission platforms

Ready to build compliant software?

See how Supernal Coding helps life sciences & pharma teams build faster without compromising on compliance.