21 CFR Part 11 Liquid Color Measurement — Vista L2-ER

Vista L2-ER is a transmission spectrophotometer for color and haze in transparent and translucent liquids, built for pharmaceutical, biotech, petrochemical, food, and chemical manufacturing.

Vista L2-ER starts with everything the Vista L2 offers: the industry's most advanced color analysis software, a spill-resistant sample compartment, and onboard PC computing power and storage. It then adds built-in electronic records with e-signatures and data-integrity features that support FDA 21 CFR Part 11 compliance and is designed for EU GMP Annex 11 and Japan's MHLW ERES environments.

Audit-ready by design
Every measurement is stored as a protected electronic record. The operator details. The instrument serial number. The standardization data. The date and time. All of it travels with the result.

A locked, reproducible audit trail
Results are written into a locked audit trail with an automatic time stamp. Vista L2-ER reproduces them in human-readable and electronic form, whenever an inspector asks.

Controlled access. Locked signatures
Only authenticated users get in. Their role decides what they can do. Password management and locked electronic signatures bind each approval to a named person.

Pass or fail, as the measurement lands.
Set up the data views each analyst needs. Every reading is marked against your specification the moment it is taken.

Validation documentation, included
A printable Validation and Compliance Notebook ships with the instrument. I-Q, O-Q, and P-Q, backed by HunterLab's ISO/IEC 17025-accredited calibration. Ready from day one.

Records that reach your enterprise systems
Export as PDF, CSV, or XLS. Results move through the instrument's ports into LIMS, SPC, and MES. Nobody re-types a number.

Update locally, or push across the network
Update Vista L2-ER by USB, online from the instrument, or remotely through EasyMatch Quality Central, which pushes update files over the network to every connected instrument. 

Flexible Pathlength Measurement and Small Sample Volumes
Vista L2-ER delivers absolute color from standard 10 to 50 millimeter cells and vials, automatically reporting pathlength and APHA in cells far smaller than others require. No costly, hard-to-clean specialty cells. It reads very small spectral differences on sample volumes as low as 0.4 mL, which matters when biopharma samples are expensive.

Upgrade to audit-ready color and turbidity measurement with Vista L2-ER. See how it fits your validated quality system.