PRODUCTS AND SERVICES CATERING TO THE NEEDS OF FDA-REGULATED COMPANIES

As HP's only Goto-Partner for Life Sciences, Genilogix's Life Sciences Practice has been the leader in applying automated testing technology to FDA-regulated environments. The two companies have a long history of collaboration.

Read HP's white-paper on Automated Testing in FDA-Regulated Environments >

Genilogix's brings experience in a number of application environments common to life sciences:

• Validation Accelerator with e-Signature
• LabWare LIMS
• SAP, Oracle E-Business Suite (and other ERP's)
• Siebel (and other CRM's)
• TrackWise
• Waters Empower
• Documentum
• HP's TestDirector for Quality Center
• Custom applications

We also provide solutions that incorporate project management, application configuration and computer systems validation (CSV) for TrackWise and LabWare implementations.

For more information on our Life Sciences solutions, please call (215) 362-1249 or send email to lifesciences@genilogix.com

Product brochure
(Acrobat format - 236K)

The e-Signature for Quality Center Add-In provides features required to comply with 21 CFR Part 11 and other standards. Genilogix developed this based on core functionality found in TestDirector for Quality Center to assure that your e-Signature implementation will survive as it evolves. With it, companies can provide e-Signatures to approve requirements, tests, test sets, runs, and defects. The related workflow can be customized to match your process.

For more information on pricing, evaluation and distribution, please contact a Genilogix representative.

Product brochure
(Acrobat format - 126K)

The Validation Accelerator with e-Signature for Quality Center provides an efficient means for automating the management of the validation testing process within a regulated environment, and delivers all of the benefits of using Electronic Signatures. The implementation of the Validation Accelerator builds measurable efficiencies into the validation process and streamlines the supporting test activities through automated test management.

The Validation Accelerator includes a services engagement to configure Quality Center for each organization’s particular understanding of compliance practices, and to accommodate an organization’s particular workflow in support of their specific validation testing process. Validation Accelerator for Quality Center includes:

• Client Specific project template configuration, including workflow and eSignature implementation, validation documentation, and validation services
• Computer System Validation process Integration, including adaptation of tool to existing client validation processes, development of supporting procedures (i.e. QC project implementation procedure), as well as training, maintenance, and support

The Validation Accelerator leverages a comprehensive set of validation documents to accelerate the validation effort, including:

• Validation Master Plan
• Configuration Specification (CS)
• System Requirements Specification (SRS)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• SOP checklist
• Traceability Matrix
• Final Validation Report

In addition, Genilogix can provide a turn-key validation project including validation documentation as well as consulting services to execute the validation scripts.



Product brochure
(Acrobat format - 210K)

The Performance Testing Accelerator for LabWare LIMS provides turn-key proven methodology and pre-defined LoadRunner scripts to test core LabWare LIMS performance. This packaged solution dramatically reduces the project timeline, by combining the market leading performance testing tool, with extensive knowledge on how to apply it LabWare LIMS to achieve quick results. The scripts include:

• Login an unreceived sample
• Receipt of unreceived samples
• Enter results for received samples
• Reviews and authorizes entered test results
• Reviews and authorizes samples that have authorized tests, and releases the sample after authorization
• Creates a report using the SUMMARY_REPORT template
• Updates the description of an analysis, which represents a user editing static data

Additional business processes can be scripted as well to test against an existing User Requirements document.

For more information on pricing, evaluation and distribution, please contact a Genilogix representative.

Product brochure
(Acrobat format - 236K)

Testing Accelerator for LabWare LIMS reduces the cost of validation by providing you a pre-assembled HP Quality Center Project consisting of an automated set of operational qualifications for LabWare LIMS created in QuickTest Professional.

Benefits of the Testing Accelerator for LabWare LIMS include:

• Use a pre-built test library of automated scripts to reduce the cost of regression testing, letting you benefit from available software patches and releases
• The Repository of tests and results features pre-configured reports to greatly reduce the time and costs of generating validation reports
• Employing data-driven tests can more thoroughly challenge the application, increasing the likelihood of detecting all errors before deployment
• Establish best practices guidelines, complete with documentation, for current and future automation testing needs
• Enhance automated test execution, defect tracking and resolution within a single, web-based platform

For more information on pricing, evaluation and distribution, please contact a Genilogix representative.

The Life Sciences Practice provides quality computer systems validation, 21 CFR Part 11 solutions and compliance consulting services to the pharmaceutical, biotechnology, and medical device industries. Genilogix focuses on providing cost effective, practical validation solutions to companies operating within an FDA regulated environment. Our professional staff has experience with manufacturing, laboratory, and clinical applications as well as business systems. Genilogix offers customized solutions for the implementation of automated testing and test management tools by working with each customer to satisfy the requirements of their specific validation process.

Our CSV solutions include:

• Turnkey validation projects: plans, requirements, design and development, RTM, IQ, OQ, PQ, testing, validation reports
• Outsourcing Services: short and long-term onsite support.
• 21 CFR Part 11 related services: Assessments and remediation
• CSV training: Conducting CSV-related training workshops and seminars

Genilogix takes a broad approach and can automate testing of most applications, either commercial or in-house. Because modern environments include complex electronic interactions, testing and validation can also include integration between applications. Genilogix works with each organization to determine what applications are critical for validation and identifying automation candidates that will produce the largest return on investment (ROI) for the customer. Genilogix professionals have a wide range of CSV-related system experience, including:

• General services: 21 CFR Part 11 Assessment/Remediation, Gap Analysis, Quality Systems Audits, SOP Development, Customized training, and Automated testing services
• Business Systems: ERP, Electronic Data Management, and Document Management
• Laboratory Systems: Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition Systems (CDAS), Spectrophotometers FTIR/UV-VIS, and other analytical software
• Manufacturing Systems: MES , PLC, DCS, and SCADA
• Clinical Systems: Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS)

Genilogix also provides a wide range of technology to accelerate validation according to the customer's applications and specific needs. For more information on our services, please contact a Genilogix representative.