AutoChrom: Using software in a validated environment (general guidance)

Description
In environments where instruments and chromatography data systems are fully validated, AutoChrom is often used on separate, non‑instrument PCs. IT or validation groups may perform their own qualification of AutoChrom prior to deployment, even if it is not installed directly on validated instrument control computers.

Solution

1. Deployment architecture typically used:
   • Install AutoChrom on stand‑alone or lab workstation PCs, not directly on tightly controlled instrument PCs, especially when those are reserved only for CDS software.
   • Connect AutoChrom to instrument data indirectly (for example, by accessing exported data or CDS project folders), according to local procedures.
2. Validation approach commonly used:
   • The customer’s IT/validation team receives the AutoChrom installer and license keys.
   • They perform internal testing (virus/malware checks, stability checks, basic functional checks) according to their SOPs.
   • Once IT/validation approves, AutoChrom can be installed in production.
3. For regulated environments:
   • Ensure that the installation, configuration, and usage of AutoChrom are covered by your internal quality system (IQ/OQ/PQ or similar).
   • Document how AutoChrom is used in relation to validated instruments and CDS:
     • For example, “AutoChrom is installed only on analysis workstations and does not control instruments directly.”
4. If asked specifically “how to validate AutoChrom”:
   • Refer to your organization’s validation policies.
   • Treat AutoChrom similarly to other data processing or optimization tools: define intended use, perform testing based on representative scenarios, and document results in a validation report.