Data Integrity Options for
GMP Facilities
For the Agilent Cary 3500 UV-Vis
Spectrophotometer

Software to help meet global regulatory requirements
The Cary 3500 UV-Vis spectrophotometer is compatible with the Agilent
OpenLab software suite of products. OpenLab provides technical controls tosecurely acquire and store data in laboratories that must comply with FDA 21
CFR Part 11, EU Annex 11, and similar regulations in other countries. Thesecontrols include:
Access control and secure data
Cary UV Workstation provides seamless method
setup and analysis capabilities. When combinedwith Agilent OpenLab, data integrity is assured
with secure database storage for all electronicrecords.

Extensive technical controls minimize the need for procedural controls,
and prevent operators from deleting or manipulating data. Assign accessprivileges based on job function and data type so that the right people havethe right access to the right information. Store and archive your data on asingle system or from labs located on a single site, on multiple sites, andacross the globe. Advanced disaster recovery tools are also included.
Electronic signature workflows
E-signatures can be executed at multiple authority levels and signature ordercontrol can be enforced. E-signatures show the full name of the signer, as
well as the date and time. Reasons for E-signatures can be predefined andare recorded with the E-signature. The reasons can be viewed either in theelectronic record or on a printed version of it.

Advanced audit trail review

The Cary 3500 has:

Secure, computer-generated, time-stamped audit trails automatically track allactions. Advanced tools for reviewing an audit trail include text or category
searches and date and user name filters. It's also possible to document theaudit trail review as part of the electronic record.

–Enhance operations
The Cary UV Workstation software includes a Help and Learning Center tohelp you get familiar with the software faster, reducing training time andcosts. Simplified workflows mean setting only the parameters that matter,
while data is quickly turned into meaningful results.

Securing and managing Cary 3500 UV-Vis data with OpenLab
Agilent offers two configurations of Cary UV Workstation where data is storedin OpenLab:–

Data is stored and managed locally, on the PC attached to the Cary 3500–

Data is stored and managed centrally in one of the OpenLab options
shown in the following diagram

Other features of the Cary 3500
The design of the Cary 3500 has minimal moving parts and removes common
sources of error in UV-Vis measurements, giving you greater confidence inyour data.
OpenLab ECM XTOpenLab Server

Systemadministration

Systemadministration

Secure storage(Agilent data systems)

Secure storage(Agilent data systems)

Multi-language
Multi-language

Systemadministration

Systemadministration

Secure storage(Agilent & non-Agilent
data systems)

Secure storage(Agilent & non-Agilent
data systems)

Multi-languageMulti-sites

Cloud storage

Unlimited eSignatures
instrument
connections

Cloud storage+4

Limited instrument
connections

Unlimited eSignatures
instrument
connections

Learn more.
www.agilent.com/chem/networked-uv-vis

This information is subject to change without notice.
© Agilent Technologies, Inc. 2021, 2022
Published in the USA, August 23, 2022
5994-0740EN

You can increase productivity by measuring
more samples, faster:– Never miss critical information with a datacollection rate of 250 points
per second– Simultaneously measure standards,
samples, and controls, under
the same conditions
The complete solution from Agilent:– Meet pharmacopeia regulations withexcellent instrument performance andinbuilt automated test suites– Qualify and validate your system with
Agilent's comprehensive portfolio ofcompliance services for both instrument
software qualification and Computer
System Validation (CSV)–

Agilent Cary 3500–

Agilent OpenLab Data ManagementSolutions–

White paper: Support for Part 11/Annex
11 Compliance with Cary 3500–

Pharmaceutical Analysis Using UV-Vis:
Compliance with USP Chapter <857>,
and European Pharmacopoeia (Ph. Eur.
Chapter 2.2.25)–

Pharmaceutical Analysis using UV-Vis:
Compliance with Supplement I to theJapanese Pharmacopoeia 17th Ed.,
Section 2.24

–Agilent Computer System
Validation Services

Unlimited eSignatures
instrument
connections

An OpenLab solution can be tailored to suit the size of your organization.

DE57469904– Air cooled sample temperature control
from 0 to 110 °C with no water,
noise, or cables

Further information

Expansion to support non-Agilent

OpenLab Basic Server

OpenLab ECM

The ability to measure the fullwavelength range, on eight cuvettepositions, simultaneously