Compliance as a background process
ARC is Agentic Regulatory Compliance for the TestLauncher fabric — continuous monitoring across GAMP 5, CSV, and ERP/QMS that turns audits from multimillion-dollar fire drills into an invisible background process.
Monitor. Generate. Prove.
ARC turns the audit from a periodic fire drill into a continuous, defensible record — built as a byproduct of how you already work.
- 01
Monitor
Agents continuously watch your systems, changes, and processes across the regulated footprint you define.
- 02
Generate
Traceability and audit evidence accumulate automatically — a defensible record built as a byproduct of how you work.
- 03
Prove
Walk into a review with an always-current record instead of a months-long assembly project.
Designed to support the regimes you answer to
ARC is designed to support programs working toward the frameworks below and generates the traceability and evidence they call for. Naming a framework here is not a claim of certification — certification is granted by your auditors, not by software.
- GAMP 5
Good Automated Manufacturing Practice — validating computerized systems in regulated industries.
- CSV / CSA
Computer software validation and the risk-based Computer Software Assurance evolution.
- FDA 21 CFR Part 11
US requirements for electronic records and electronic signatures.
- EU GMP Annex 11
The EU good-practice annex for computerized systems.
- ISO 9001
Quality management systems — the baseline for consistent, controlled processes.
- ISO/IEC 27001
Information security management for the data your evidence depends on.
Priced for the programs it protects
ARC is enterprise software — priced to your regulated footprint, the systems in scope, and your deployment. Talk to us and we’ll scope the right setup with you.
Agentic Regulatory Compliance on the systems in your scope — sovereign or on-prem deployment, SSO, and onboarding.
Talk to salesARC plus the full fabric — Launch App, bugAgent, qualThread, and manualTesting on one owned foundation.
Talk to salesFrequently asked questions
- What is ARC?
- ARC — Agentic Regulatory Compliance — continuously monitors your programs across GAMP 5, CSV, and ERP/QMS and generates the evidence they call for. It turns compliance from a multimillion-dollar audit fire drill into an invisible background process.
- What does “agentic” compliance mean?
- Instead of assembling evidence by hand before an audit, agents watch your systems and processes continuously, flag drift as it happens, and produce a defensible, always-current record — so compliance keeps pace with how fast you actually ship.
- Does ARC make us certified?
- No — certification is granted by auditors and notified bodies, not by software. ARC is designed to support programs working toward regimes like FDA 21 CFR Part 11, GAMP 5, CSV, and ISO expectations, and to generate the traceability and evidence those reviews require. It makes your program audit-ready; it does not replace the audit.
- How does ARC fit with the rest of the fabric?
- ARC runs on Launch App, the sovereign foundation, and shares one owned data layer — the QA Brain — with bugAgent, qualThread, and manualTesting. Evidence generated by how you test and work flows straight into your compliance record instead of being rebuilt by hand.
- How is ARC priced?
- ARC is enterprise software, priced to your regulated footprint, systems in scope, and deployment — not sold in fixed public tiers. Talk to our team about your programs and we’ll scope the right setup, including sovereign or on-prem deployment.
Make the next audit a non-event.
Tell us about your regulated programs and systems — we’ll show you what continuous, agentic compliance looks like for your enterprise.