Healthcare

WHITE PAPERS AND CASE STUDIES

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Providing Packing And Blinding Solutions For An Innovative Drug Start-Up

  Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.

• Optimizing EDC Strategy And Data Collection for a Rare Disease Trial

  Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.

• Developing A Data Strategy For Clinical Trials

  This white paper outlines a standardized method for developing a data strategy that can be tailored to a company's current needs and adapted as those needs evolve.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Tackling Antimicrobial Resistance

  Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• 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.

• How A Leading CDMO Reduced Yield Variability With Automation

  Explore the transformative journey of a leading CDMO company and how they adopted an innovative platform that enhances data analytics and drives pharmaceutical manufacturing advancements.

• Blending Tradition And Technology For A Water-Resilient Future

  Discover how a desert utility is evolving its operations to safeguard Tucson’s water supply for generations to come.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.