CHROMELEON® 7.

3
Statement of 21 CFR Part 11 Readiness
This certifies that Chromeleon software and any related Service Packs and Service Releases was
designed to provide software capabilities in accordance with the U.S. FDA 21 CFR Part 11 for
Electronic Records and Electronic Signatures. These capabilities include but are not limited to the
following:

• Features for the control of closed systems including validation, generation, and protection of
records, controlled system access and use of computer generated, time stamped audit trails
(11.10).
• Electronically signed records indicating signer, date/time, and meaning of signing (11.50).
• Electronic signatures linked to the electronic record to ensure signature fidelity (11.70).
• Unique electronic signatures with two distinct identification components (11.200).
• Control for identification codes/passwords, including uniqueness and password aging (11.300).

Thermo Fisher Scientific believes that the Electronic Signature and Signoff feature and system security
features, if properly implemented by the end user, will allow the Chromeleon software to operate in the
end-user environment as closed systems. These features, in combination with appropriate end-user
administrative controls and procedures, provide a system that complies with the requirements of 21 CFR
Part 11, including validation of the data systems (11.10a), generation of accurate and complete records
in human readable and electronic format (11.10b), protection of records for accurate and ready retrieval
(11.10c), controlled system access to the Chromeleon system by authorized individuals (11.10d), use of
secure, computer-generated, time-stamped Audit Trails (11.10e), use of operational system checks as
appropriate (11.10f), use of authority checks to control use of the system and control electronic signature
(11.10g), use of device checks as appropriate (11.10h), establishment of written policies dealing with
actions of electronic signatures by the end user (11.10i and j), and use of controls over system
documentation (11.10k).

Yoon H Kim
Yoon H. Kim
Director, Quality
HPCS Business Unit

Product Name: Chromeleon

Version 7.3

Dionex Softron GmbH,

a part of Thermo Fisher Scientific
Registered to ISO 9001
Certification No. A28651

Thermo Fisher Scientific (001) 781 -622-1000 doc. 091764

81 Wyman Street
www.thermofisher.com
Waltham, MA 02451