WHITE PAPERS AND CASE STUDIES

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• 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.

• Life-Saving Treatments Reach Patients Faster

  Follow LivaNova's journey as they search for a solution to simplify and streamline trial initiation and management processes to expedite the delivery of life-saving devices.

• Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

  Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Nevro Eliminates Majority Of Source Data Verification With ePRO And EDC

  Read how a global medical device company was able to unlock new efficiencies by implementing data collection via electronic patient-reported outcome assessments.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators

  Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

• Aegea Creates Brazil's Largest 3D Digital Sanitation Map As Part Of Their Intelligent Infrastructure Program

  In this case study, learn about a highly interactive 3D map representing over 1,000 sanitation facilities in a virtual reality environment which optimizes performance, service availability, and reliability.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Democratize Batch Data Management For AAV Gene Therapies

  Explore a biotechnology company's process of choosing a data management solution that offered centralized batch data management, allowing the company to streamline its CMO data delivery process.