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.

• 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.