WHITE PAPERS AND CASE STUDIES

• Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination

  Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

• Understanding And Implementing USP <665> For Single-Use Systems

  New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

• Overcoming Participant Compliance Challenges In A Medical Device Study

  Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.

• Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration

  Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

• End-To-End Workflow Integration For Antibody Development

  Modern antibody discovery generates massive, fragmented datasets that slow collaboration and decision‑making. Examine how unified digital workflows streamline R&D and improve data quality.

• What FDA CRLs Reveal About Method Validation

  FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Sustainable Solutions For Medical Devices

  Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Mobile App And Wearable Integration Collects Longitudinal Data

  Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.

• Electronic Batch Reporting

  Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

• Verve Puts Digital-First Quality At The Heart Of Its QC Lab

  Learn how a biotech scaled faster by building a paperless lab, adopting cloud-based LIMS, and streamlining QA/QC processes to reduce errors, improve efficiency, and enable real-time collaboration.