Does purchasing instrument software establish Part 11 compliance?
No. Compliance assessment includes the configured system, its intended use and the laboratory's procedures. Discuss the relevant software options and qualification documentation with Glen Mills.
Confirm the installed software version and licensed functions before relying on a feature description. Define user responsibilities, review procedures and backup arrangements alongside the instrument records. A software capability matrix is useful implementation information, not an independent certification that an entire laboratory workflow is compliant.
How can a lab test recalculation in FLEX?
Use a test measurement and a user account with the intended permissions. Save the result, change a calculation input and retrieve the original and recalculated records. Inspect the recorded user, change history and retrieval workflow against the laboratory’s written requirements.
Method details to record
| Consideration | What to record |
|---|---|
| Software configuration | Version and enabled functions |
| Record lifecycle | Access, history and retention |
| Laboratory controls | Validation and operating procedures |
What should the qualification record identify?
Record the installed FLEX version, enabled features, user role, test input and expected and observed behavior. FDA guidance ties the scope of Part 11 to the electronic records and signatures the laboratory actually relies on. Have the responsible quality team determine applicability.