Validation, Commissioning & Design Products & Services

  1. Should You Digitalize Your CQV Process? 8/6/2024

    Legacy paper trails are a compliance nightmare.

    Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.

  2. Leave Paperwork Behind In Your CQV Process 8/6/2024

    ValGenesis VLMS: The Industry-Leading Platform For Digital CQV

  3. Digital Validation Lifecycle Management Software 7/10/2024

    The leader in digitizing validation

    Setting the digital validation standard for 20 years, ValGenesis VLMS is used by 30 of the top 50 global life sciences companies.

    The gold standard of standardization

    Strengthen your compliance stance and lower the cost of quality with enforced standardization and absolute data integrity.

    Knowledge integrity to data integrity

    Gain total peace of mind with a single source of validation truth with documentation aligned to ALCOA+ standards.

    One platform, boundless scale

    Start small or start global. VLMS scales effortlessly to support new systems, new sites, new products, new languages, and new validation processes.

  4. Batch Manufacturing Software For Pharma 7/2/2024

    Visualize Batch Production Like Never Before

    Experion® Batch combines compact Experion distributed control, batch automation, and advanced visualization technology to provide a solution optimized for pharmaceutical, specialty chemical, food and beverage, and similar applications.

  5. Pharmaceutical X-Ray Inspection System 6/27/2024

    The XR75 Pharma X-ray is optimized for the quality control of pharmaceutical, nutraceutical, and cosmetic products in thin opaque packaging materials that cannot be inspected manually or with visual systems. The leakage prevention curtains are designed to leave a 10 mm-clearance that ensures safety and reduces false rejects caused by product jams or changed orientation during conveyance. The system checks for different product integrity issues simultaneously: products trapped in seals, missing, chipped, or broken tablets in blisters, and the presence of foreign contaminants. The high-resolution X-ray images ensure reliable inspection of the small items at belt speed up to 90 m/min.

  6. Empower Lab Management System 3/13/2024

    Integrated solution to elevate your workflows

    Automating your laboratory workflow from initial sample creation to final archival is vital to achieving data integrity and to supporting day-to-day laboratory productivity. Empower LMS delivers a uniquely integrated experience, combining the industry-leading benefits of Empower Chromatography Data System (CDS) with the added workflow management capabilities of NuGenesis Lab Management System (LMS), including the Scientific Data Management System (SDMS).

  7. Computer Software Assurance (CSA) And Computer System Validation (CSV) 3/4/2024

    CAI’s Kneat: Data Ready provides you with best-in-class content and templates created by industry-leaders, giving you a headstart in implementing your own Kneat solution.

    Kneat: Data Ready offers not only templates, but a validated out-of-the-box configuration that you can tailor to your business needs. Implement your Kneat instance in less than half the time.

  8. Validation And Quality Management Software Platform 3/4/2024

    Kneat enables regulated companies to consolidate validation and quality management into a single end-to-end web-based software platform.

    CAI’s Kneat: Project-Ready allows your company to utilize a validated Kneat instance to execute your projects without start-up and on-going maintenance. Project-Ready does the heavy lifting for you with pre-designed processes and templates.

  9. Quality Management Software for Drug Manufacturers 2/27/2024

    Increasing visibility, efficiency, and control to ensure quality for CDMOs and Generics.

  10. Quality And Risk Management Software For Life Sciences 1/17/2024

    Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.