The laws are strict and enforcement is getting tougher. A single compliance violation could cost your company millions in fines and lost revenues. You know you need to comply with the rules, but how can you make your existing chromatography systems and operations compliant? How can you cope with an increasing workload of analyses while still ensuring that you're always ready to pass an audit?

You need a solution that meets compliance requirements and increases your productivity. You need Chromeleon^®.

For details on how Chromeleon can help you achieve compliance with 21 CFR Part 11, see Technical Note 54.

Security that Fits Your Workflow

Get the controls you need for a secure and productive laboratory, whatever your environment.

Get fine-grained control over specific chromatography objects and operations with the comprehensive security system built into Chromeleon. Over 100 different chromatography privileges can be allocated as appropriate to any number of Privilege Groups, so you can control who can run samples, which can modify methods, which can change peak baselines, and so on. You can also control access to specific instruments and data folders by defining any number of Access Groups. Security administration tools let you set rules for login and signature passwords, and automatically lock inactive stations and accounts that have too many login failures. All security-related events are automatically tracked in a detailed security log.

Chromeleon's user manager gives the system administrator(s) fine-grained control over each user's access and operational privileges.

Chromeleon controls access to data sources, individual folders, and instruments. Users who are not members of an access group assigned to an item cannot access or even see the item.

User and password history logs are automatically maintained.

Users can be automatically locked out after a preset number of login failures, using Chromeleon's customizable security features.

Administrators can set an inactivity timeout policy to help ensure that unauthorized people do not gain access to the system in the event that an authorized user fails to log out before stepping away.

Fully Automated Validation

With Auto ^™ automated qualification, validating your chromatography systems becomes almost effortless.

The basic concept behind validation is simple: prove that the results generated by a system can be trusted. Unfortunately, generating the proof tends to be a tedious chore, and so is the job of keeping all the documentation in order. It's no wonder that so many people dread the whole issue of validation.

Validation doesn't have to be painful. The validation tools built into Chromeleon automate the process of qualifying your instruments and methods. A few clicks of the mouse are all you need to set up and launch the appropriate tests—you can go attend to other tasks while Chromeleon generates detailed, comprehensive documentation of your system's configuration and performance.

Equipment validation becomes almost effortless with the following Chromeleon tools:

Software Installation Qualification (IQ): 

Software IQ verifies correct computer platform, operating system, and installation of all program files and libraries.

Software Operational Qualification (OQ): 

Software OQ uses a known data set to verify proper operation of the Chromeleon client and server modules, as well as the software's integration, quantification, and reporting routines.

Instrument Installation Qualification (IQ): 

Instrument IQ uses predefined templates to generate and run sequences that verify basic communication with instrument components.

Instrument Operational Qualification (OQ): 

Instrument OQ uses predefined templates to generate and run sequences that test performance of each system component and ensure conformance with factory specifications.

System Performance Qualification (PQ): 

System PQ uses method-specific templates to generate and run sequences that test consistency of system performance in the application configuration.

Method validation is also made much easier, thanks to the following Chromeleon features:

Method Qualification: 

Common performance measurements (efficiency, resolution, tailing, precision of retention time, precision of response, linearity of response) are included in default reports; other method qualifications (signal/noise, LOD, LOQ, recovery, and so on) can be readily included in any report.

System Suitability Testing (SST): 

Any analytical method can be configured to run any set of chromatographic tests, each applied to individual samples or across multiple samples matching specific criteria, with detailed suitability results and optional automatic shutdown of systems failing suitability.

Chromeleon puts validation issues behind you, and lets you focus your time and attention on productive work.

Included with each copy of Chromeleon software is an electronic copy of the Certificate of Validation that certifies the software has been designed, tested, validated, and distributed in accordance with documented Software Development Life Cycle procedures compliant with ISO 9000-3 standards.

Chromeleon's software installation qualification (IQ) verifies that the computer environment is correct and all files are correctly installed, and generates a detailed configuration report.

The software operational qualification (OQ) proves that the components of the software are communicating properly, and tests the calculation of every reportable result variable.

Chromeleon's OQ and PQ wizards automatically generate the sequences needed to qualify your instrument. All you do is load your autosampler and select "Start". Chromeleon does the rest.

Built-in OQ and PQ test suites analyze the performance of each component of your chromatography system, and produce detailed documentation.

Continuously monitor the performance of your chromatographic system by specifying any desired set of system suitability tests as part of your method.

Detailed Audit Trails

Achieve full regulatory compliance while increasing productivity.

With the comprehensive audit trails of Chromeleon, you always have the documentation you need to defend your results. Every event related to instrument control and data acquisition is automatically captured in event logs. Every change to a baseline, quantitation method, or calibration is tracked in the modification history. And all security-related events—logins, password changes, privilege changes, and electronic signature events—are recorded in a detailed history log.

But Chromeleon does more than just capture the audit trails; it also helps you extract the information you need out of them, quickly and easily. View the events pertaining to a single sample, sequence, or entire data warehouse. Filter the display down to records matching a specific user, time period, or event type, and sort the filtered list simply by clicking on column titles. Print the filtered and sorted list directly, or embed the audit trails directly in your analytical reports.

For every instrument, Chromeleon automatically maintains a detailed record of all control instructions, instrument responses, and other significant events. View audit trails at any of four levels of detail.

View instrument event logs in real time as samples are analyzed.

The subset of an event log that pertains to a specific sample can be easily viewed and reported, together with other data and metadata from that sample.

The log command dialog lets you automatically record, in the system's audit trail, the status of any system parameter (such as pump pressure or lamp intensity) at any desired time.

Seamless Electronic Signatures

All the functions you need to implement paperless record keeping are seamlessly integrated into Chromeleon.

With today's regulatory and economic pressures, paper-based record keeping is no longer practical. Electronic record management is clearly the way forward, but how can you be confident that the solution you deploy will satisfy compliance requirements? And how can you be sure that going electronic won't hinder your lab's productivity with cumbersome new operating procedures?

With Chromeleon, the answers are clear. Secure record management is fully integrated into the software—it's built in, not bolted on. All of the processes for document creation, review, and approval fit right into the natural laboratory workflow so you can eliminate the paper chase without having to completely restructure your operations. Therefore, you achieve both compliance and improvements in productivity.

Chromeleon's security system provides all the facilities needed for electronic records management, including positive user identification, access control, password controls, privilege management, and positive linking of signatures and records.

The list of authorized signatories for submission, review, and approval of results are specified separately for each sequence.

To sign results for a sequence, you simply select the signature menu command or toolbar button...

...and select the report sheets and samples you want to sign.

Chromeleon locks all the source data and report sheets, then provides you with the opportunity to check all the report pages before applying your signature.

The electronic signature is applied by entering a user-specific signature password. Using the signature data and the report contents, Chromeleon calculates a hash code that becomes an integral part of the encrypted final report and certifies its authenticity.