1

PRODUCT SPECIFICATIONS

Key featuresKey featuresKey featuresKey featuresKey features••••• Adaptable and comprehensive user manage-user manage-user manage-user manage-user manage- ment systemment systemment systemment systemment system for access control••••• Audit trailAudit trailAudit trailAudit trailAudit trail automatically records all significant changes and operator actions••••• User-definable electrelectrelectrelectrelectronic signaturonic signaturonic signaturonic signaturonic signatureseseseses to meet diverse laboratory requirements••••• Build-in file integrityfile integrityfile integrityfile integrityfile integrity and security for method and result files

HAAKE RheoWin software21 CFR part 11 tools

IntroductionIntroductionIntroductionIntroductionIntroductionThe Themo ScientificTM HAAKETM RheoWinTM software with21 CFR part 11 tools helps users in both research andquality control to comply with the stringent requirementsof the regulated industry. It provides an user manage-ment system, file integrity, an audit trail and electronicsignatures to ensure that the integrity of electronicrecords is always maintained.

HAAKE RheoWin softwareHAAKE RheoWin softwareHAAKE RheoWin softwareHAAKE RheoWin softwareHAAKE RheoWin softwareHAAKE RheoWin is the universal rheometer softwarefrom Thermo Fisher Scientific for rheological measure-ments ranging from routine quality control measure-ments to sophisticated R&D work. Since its introductionin 1997 HAAKE RheoWin has set standards regardingeasy-of-use with its unique JobEditor user interface.The Job-Editor, which is part of the HAAKE RheoWinJobManager program allows the definition of highlyflexible and fully automated methods (called Jobs inHAAKE RheoWin) using simple drag & drop functional-ity, for increased laboratory productivity. In HAAKERheoWin Jobs can consist of a sequence of measure-ment and/or evaluation routines. All available measure-ment routines (for flow-curve, creep-recovery, frequencysweep, strain sweep, temperature ramp measurement,etc.) can be combined and mixed with all automaticdata evaluation routines, user-defined messages, reportgeneration etc. in any needed sequence.

Jobs can also be defined and controlled externallyfrom data systems like SAP and LIMS using a script-language that is build into HAAKE RheoWin.

The HAAKE RheoWin DataManager program offers ex-tended functionality for interactive evaluation of measured

data as well as sophisticated tools for the creation ofreports which can be printed and exported in the follow-ing formats: PDF, Word, Excel, XML, HTML, TIFF, JPG,etc.HAAKE RheoWin is equipped with a comprehensive usermanagement system for access control. The user man-agement system includes password controls like mini-mum password length, password uniqueness, passwordage limits, etc.. More than 140 specific privileges, basedon pre-defined or user-defined user groups, can beassigned to each user, exactly defining the scope ofactivity of that user.The optionally available 21 CFR Part 11 tools add audittrail and electronic signature functionality to HAAKERheoWin. By maintaining a secure, computer generated,time stamped audit trail, HAAKE RheoWin automatically

1

tracks all operator entries and actions that create, modifyor delete electronic records. The audit trail records thetime and date of each event, along with the name of theoperator involved. The system administrator can grantspecific user groups or individual users the privilege ofapplying electronic signatures to both HAAKE RheoWinJob and Data files.

HAAKE RheoWin combines the power of the Windowsoperating system with your laboratory’s network to provideimproved performance essential for the productiveoperation of all of your rheological techniques.

The FDA and 21 CFR part 11The FDA and 21 CFR part 11The FDA and 21 CFR part 11The FDA and 21 CFR part 11The FDA and 21 CFR part 11The Electronic Records and Signatures Rule, known as21 CFR Part 11, was established by the U.S. Food andDrug Administration (FDA) in order to define require-ments for the use of electronic documents in lieu of paperrecords. The law, published in the Federal Register onMarch 20, 1997 and in effect since August 20, 1997,specifies the system elements, controls, and proceduresthat are necessary to ensure the trustworthiness, authen-ticity, integrity and confidentiality of electronically-stored records and electronic signatures. Because com-pliance requires the combination of electronic systemsand Standard Operating Procedures, no product alonecan ensure compliance. However, products with integrat-ed functionality that meets the 21 CFR Part 11 require-ments can significantly ease the task of achieving andmaintaining full compliance with the law.

In response to 21 CFR Part 11 and the increasing datasecurity requirements in other industries, Thermo FisherScientific developed the HAAKE RheoWin 21 CFR part 11tools to offer the „technical compliance“ needed to meetthese mandatory regulations. With the HAAKE RheoWin21 CFR part 11 tools, the regulated industries will be con-fident in their ability to provide the complete story aboutthe generation and handling of the data.

Thermo Fisher Scientific makes its security functional-ity available to both existing and new customers. TheHAAKE RheoWin 21 CFR Part 11 tools are fully compa-tible with the current range of HAAKE MARS, HAAKEViscotester iQ, HAAKE RheoStress 1, HAAKE Roto-Visco 1, and HAAKE Viscotester D and E instrumentsas well as with many older instrumens like the HAAKERheoStress 6000 and the HAAKE Viscotester 550.Users may be required to upgrade to a newer versionof the HAAKE RheoWin applications software to beable to use the HAAKE RheoWin 21 CFR Part 11 tools.

File integrityFile integrityFile integrityFile integrityFile integrityHAAKE RheoWin and the 21 CFR Part 11 tools provideseveral layers of protection to ensure that accuraterecords can be readily retrieved. The foundation for recordprotection is a secure operating system (Microsoft®Windows 7, 8(.1) and 10 with the NTFS file system) thatprovides positive user tracking and prevents unauthoriz-ed access to computers and files.

HAAKE RheoWin initially provides one administrator userwith a set of privileges that is limited to configuring thesystem and four predefined user groups. These groupscan be used as is or modified as needed. In addition,new groups can be created and privileges assigned tomeet your laboratory’s specific requirements. Over 140different privileges can be granted to each user.

To ensure that only authorized individuals can use thesystem, electronically sign records, access systemfunctions, modify electronic records etc., the HAAKERheoWin’s security system provides the user manage-ment capabilities most often requested by system ad-ministrators:

••••• Users are identified by a unique combination of UserID, User Name, and Job Title throughout the software.

The next layer of protection is formed by the binary fileformat of the HAAKE RheoWin method and result files(Job, Data and Page files), which ensures that even thoseusers who have access to files at the operating systemlevel cannot read or modify records through means out-side the secured application. HAAKE RheoWin methodand result files are protected against external file tamper-ing by a build-in check-sum (hash-code). HAAKE RheoWinwill not load an external modified file, an attempt to loadsuch a file is registered in the Audit Trail.

Beyond the protection realized by the operating systemand the special file format, HAAKE RheoWin is equippedwith an user management system, that is a comprehen-sive security system that controls access to data. Thisensures that only authorized users are able to accessrecords and make changes; any such changes aretracked by the computer-generated audit trail.

User management system and securityUser management system and securityUser management system and securityUser management system and securityUser management system and securityThe HAAKE RheoWin 21 CRF Part 11 tools offer a securelogin process that is based on user groups and differentprivilege levels, reflecting the laboratory workflow. Forexample, the laboratory manager may be the only per-son allowed to release a new method, while a laboratorytechnician may only be permitted to use existingmethods and run certain analysis routines.

2

••••• Password requirements - such as minimum password length, password uniqueness, and password age limits - can be enforced.••••• User logins are automatically logged in the audit trail••••• Users can be automatically locked out after a pre-set number of login failures.••••• Users can be automatically locked out after a certain duration of user inactivity.

Audit trailAudit trailAudit trailAudit trailAudit trailHAAKE RheoWin with 21 CFR Part 11 tools maintains asecure, computer-generated, time-stamped audit trail,which records all changes that are made to method andresult files (Job, Data and Page files), all changes inthe program settings (JobManager, DataManager andUserManager) and user logon/off actions. For ease ofuse, audit trail items are created fully automatically withminimal user interaction. The audit trail records the what,how, who, when, where, and why of every change.

••••• What was changed (indicates the parameter that was changed)••••• How the change was made (displays the previous and the new value of the altered field)••••• Who made the change (displays user name from login)••••• When the change occurred (shows the date and time of the change)

••••• Where the change was made (specifies the file or record that was modified)••••• Why the change was made (reason for the change)

The Audit Trail is saved in a MS Access or SQL Servercompatible database file which can reside on a securenetwork drive.The Audit Trail can be viewed using the build in AuditTrail Viewer or using MS Access or any other compatibledatabase program.

Electronic signaturesElectronic signaturesElectronic signaturesElectronic signaturesElectronic signaturesAccording to the 21 CFR Part 11 regulations, an electronicsignature is defined as “a computer data compilation ofany symbol or series of symbols executed, adopted, orauthorized by an individual to be the legally bindingequivalent of the individual’s handwritten signature“and each electronic signature “shall be unique to oneindividual and shall not be reused by, or reassigned toanyone else“.

In HAAKE RheoWin an electronic signature can be ap-plied to any method or result file (Job, Data and Pagesfiles). An electronic signature in HAAKE RheoWin consistsof the User Name and Password, as two distinct iden-tification components unique to an individual, the reasonfor the signature and the date/time the signature was

2

Find out more at thermofisherthermofisherthermofisherthermofisherthermofisher.com/rheometers.com/rheometers.com/rheometers.com/rheometers.com/rheometers

For ResearFor ResearFor ResearFor ResearFor Research Use Onlych Use Onlych Use Onlych Use Onlych Use Only. Not for use in diagnostic pr. Not for use in diagnostic pr. Not for use in diagnostic pr. Not for use in diagnostic pr. Not for use in diagnostic procedurocedurocedurocedurocedures.es.es.es.es. © 2017 Thermo Fisher Scientific Inc. All rightsreserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.04170417041704170417

Because laboratory requirements vary, the HAAKERheoWin 21 CFR Part 11 tools provide an electronic sig-nature feature that is userdefinable, as well as a custom-izable reasons list.

HAAKE RheoWin can be configured so that the appli-cation of a certain number of signatures will automati-cally lock the file for any future changes.

VVVVValidation servicesalidation servicesalidation servicesalidation servicesalidation servicesThe regulation requires “validation of systems to ensureaccuracy, reliability, consistent intended performance andthe ability to discern invalid or altered records“ and theuser must validate the system to ensure that it is suitablefor use within its particular regulatory environment. ThermoFisher Scientific uses a professional software develop-ment process to ensure reliability. HAAKE RheoWin andthe 21 CFR Part 11 tools are developed following aCertified Quality System which conforms to the ISO 9001guidelines. Our software development life cycle followsthe ISO 9000 guidelines.Thermo Fisher Scientific offers Installation Qualification(IQ) and Operational Qualification (OQ) services and canassist you with Performance Qualification (PQ), ifrequired.

A complete solution from a market leaderA complete solution from a market leaderA complete solution from a market leaderA complete solution from a market leaderA complete solution from a market leaderViscometers and rheometers from Thermo Fisher Scientificare installed and validated in laboratories around the world.Thermo Fisher Scientific’s broad range of experienceincludes providing instrumentation to laboratories fol-lowing GLP/GMP regulations and the HAAKE RheoWin21 CFR Part 11 tools are yet another example of ThermoFisher Scientific’s commitment to quality and to customersatisfaction. It provides technical compliance by offeringthe additional capabilities needed by highly regulatedlaboratories such as those operating under the FDA’s 21CFR Part 11 rules. The HAAKE RheoWin 21 CFR Part 11tools can be used on many existing Thermo Scientificviscometers and rheometers and give the security re-quired by the regulated industries about the generation ofthe data. Thermo Fisher Scientific provides a completesolution, giving you the confidence needed for yoursuccess.

ImportantImportantImportantImportantImportantThe installation and proper configuration of HAAKERheoWin with the 21 CFR Part 11 tools will ensure tech-nical compliance to 21 CFR Part 11. In addition, theuser’s organization must establish a range of policiesand standard operating procedures that complement thecapabilities provided by the software in order to ensurecomplete compliance to the rule.

applied. The electronic signatures are an integral partof the files they are applied to, they can not be removedor copied from that file.