MARRS Assurance Brochure

MARRS™ Assurance MARRS™ Assurance is patented security software for achieving compliance with electronic regulatory standards, such as 21CFR Part 11, Good Manufacturing Practices (GMP), Good Automated Laboratory Practices (GALP), and more. MARRS™Assurance automatically integrates with any instrument and throughout the entire lab, providing the capability for laboratoriesto personalize the software in order to meet their lab's dynamic security needs. A critical element of MARRS™ Assurance isit's unique ability to extend the compliance to the actual use of the data, providing a truly secure layer of defensibility ofquality assurance that ensures that results used in decisions and studies have the utmost supportive quality. Furthermore,MARRS™ Assurance can seamlessly integrate within the entire laboratory Quality Assurance Program (QAP) and othercompliance systems, and is applicable to various analytical industries. • Compliance to Regulatory Agency and Industry• Compliance to Standard Operating Procedures• Compliance to Analytical Method Requirements• Compliance to Client RequirementsMARRS™ Assurance SecuritySecurity and SetupMARRS™ Assurance Security is robust with thecapability to self-define and manage Users, User Groups,Privileges, and Access Rights. User Groups can be definedto establish hierarchies of Review and Approval. Forexample a standard laboratory User Group may consist ofAnalyst/Technician, Secondary Review, QualityAssurance, and Management/Administrators. In addition to security, laboratories can personalize theMARRS™ Assurance Security for:• Continual Monitoring of instrument files, folders, and tables• Electronic Signature Types• Review and Approval• Types of Review and Approval• Instant Messaging• Work Flow/Process Flow definitionFor more information, call 888-320-3472or visit our web site at www.eisc.netContinual Monitoring, Electronic Signatures,Electronic Versioning, and Audit TrailsLaboratories can continually monitor instrument files,folders, and tables for changes and anomalies to theInstrument Environment, Instrument methods/setup, andanalytical data processing. Multiple Audit Trails capturethe electronic signatures of User ID, Windows ID,Instrument ID, Review ID, and Approval ID. ElectronicVersioning is on-going, providing a roll back feature toreview the changes and anomalies. The ElectronicVersioning mechanism can also perform an electroniccomparison of changes to files or tables in order topinpoint specific data elements that have changed.The MARRS™ Assurance Security provides the followingAudit Trails:• Instrument Environment Audit Trail: monitoring offiles, folders, and tables• Analytical Processing Audit Trail: result changes as data is processed, calculated, reviewed, automatedquality assurance, analytical anomalies, data integrity …• Analytical Review and Approval Audit Trail: Tracksreviews and approvals as the data goes through thelaboratory work flow.Work Flow/Process Flow The MARRS™ Assurance Security software allowslaboratories to self-define and manage WorkFlows/Process Flows for analytical data review andapproval steps. For example, a standard laboratory processmay contain a series of reviews and actions. Processedanalytical data may follow these steps:1) The Analyst/Technician reviewing the analytical datafor quality assurance (QA) issues. The Analyst/Technician makes decisions based on the QA andprovides analytical notes on decisions, then providessome conclusions. 2) The secondary review user picks up the Analyst/Technicians reviewed data and confirms the analyticalnotes, decisions, and conclusions for approval. 3) Specific QA issues and anomalies on the analyticaldata are sent to the QA Group for review anddiscussion.4) A completed status is passed on to the ReportingGroup. Review ChecklistsThe MARRS™ Assurance Security software allowslaboratories to self-define and manage Review Checkliststo be used in Instrument Maintenance, Instrument Setup,Analytical Review, and Secondary Review. Thesechecklists are then provided as a mechanism to ensure that proper procedures were followed by asking a series of questions of the user until the checklist is complete. The checklist is then electronically stored and provided inthe Audit Trails. Instant MessagingEach user can setup Instant Messaging profiles to inform themwhen an action is required, complete, an automated reviewsummary is available, and notification of issues, etc …These Instant Messages are automatically emailed to the user when a process has occurred that matches the user profile. Key Benefits• Ensures dynamic compliance to electronic regulatorystandards for FDA 21 CFR Part 11, CDC, DOE, DOD,EPA, HACCP, ISO, NELAP, USDA, and NuclearRegulatory Commission in data handling • Integrates to present laboratory processes with nodecrease in production• Automates and streamlines the quality assurancereviews• Communicates analytical issues and results throughoutthe laboratory • Ensures data quality and integrity• Total compliance from instrument to clientAdd-on Features Available• MARRS™ Assurance Security can be integrated with any other instrument(s)• Audit Trail integration with other compliance systems• User Scheduling for analytical studies, instrumentmaintenance, routine QA checks• Non-Conformance Reporting and Tracking• Production Analysis ModuleAbout EISCEISC is an international provider of scientific applicationsoftware that specializes in laboratory data integration andautomation. EISC’s seamless, universal, connectivityplatform assimilates and summarizes dynamic analyticalinstrument data into comprehensive analytical information.EISC was established in 1996 and is headquartered in Las Vegas, NV.