User manual

Andover Continuum
Andover Continuum
Software-5
CFR Compliance Pack
The Continuum CFR Compliance Pack software product range enhances the Andover Continuum
system to provide FDA-regulated businesses with the information they need to achieve
regulatory compliance for their facilities. Using 21 CFR Part 11 electronic record and signature
standards,CFRCompliancePackmaintainsacompletearchiveofalleventsandparameters
related to the environmental and security conditions of a facility.
A Continuum CyberStation workstation with a CFR Compliance Pack option provides multiple
benefits to FDA-regulated businesses:
•Comprehensivepasswordmanagementfeatures
•Enforcedoperatorpromptsforallsystemchangesandalarmacknowledgments
•Useraccountmanagementenhancements
•Alarmgenerationforinvalidanddisableduserlogonattempts
•Securedatapointandeventloggingandarchiving
•Powerfulreportgenerationcapabilities
•Detailedaudittrails
Basic and Advanced Features Available
TheContinuumCFRCompliancePackisavailableintwoversions,BasicandAdvanced.Both
versions include the rigorous password management and operator prompting features described
above; the difference is in the archiving and archive reporting levels.
CFRCompliancePack,BasicandAdvancedversions,areorderedbyappendingthefollowing
suffixestoanyProgrammer’sEditionofCyberStationLANsoftware.
For a System using CFR Compliance Pack Basic:
-CFRB CFRCompliancePackBasic,includestheExtendedLogArchiverandArchive
Reporter,forthefirstWorkstationONLY
-CFRBV CFRCompliancePackBasicViewer,foradditionalWorkstations,includesthe
ExtendedLogArchiveReporter
For a System using CFR Compliance Pack Advanced:
-CFRA CFRCompliancePackAdvanced,includestheExtendedLog,Alarm,User
ActivityandAccesseventArchiversandArchiveReporters,forthefirst
WorkstationONLY
-CFRAV CFRCompliancePackAdvancedViewer,foradditionalWorkstations,includes
theExtendedLog,Alarm,UserActivity,andAccesseventArchiveReporters
Note:
CFRCompliancePack,BasicandAdvanced,requiresCyberStationVersion1.6orgreater.
Continuum CyberStation CFR Compliance Pack
• CyberStationEnhancementHelpsLife
SciencesFacilitiesAchieveRegulatory
Compliance
•ProvidesFacility-wideAccountability
andTraceabilityofEnvironmentaland
SecurityConditions
•
AnswerstheWho?,What?,When?,
Where?,andWhy?Questionsofa
RegulatedFacility
• TwoVersionsAvailabletoMeetBasic
andAdvancedArchivingandReporting
Requirements
•ArchiversAvailable:
 ExtendedLogs
 AlarmEvents
 UserActivityEvents
 AccessEvents
•ArchiveReportersAvailable:
 ExtendedLogs
 AlarmEvents
 UserActivityEvents
 AccessEvents
•AutomaticandOn-demandSecured
PDFFormatReportGeneration