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WHITE PAPERS AND CASE STUDIES

• 5 Steps To Design A Microbiological Performance Qualification For Facilities

  Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Richter BioLogics Drives Efficiency And Compliance With Unified Quality

  Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Revolutionizing Biofilm Research: High-Resolution, Real-Time Imaging with ZeGage Optical Profiler

  A university lab optimized biofilm research with Zygo’s ZeGage Optical Profiler, enabling high-resolution, real-time, non-contact imaging that accelerates data collection, enhances accuracy, and preserves biofilm integrity.

• Progressing A Cystic Fibrosis Treatment With A Strong Culture Match

  Collaborate with an experienced CMO that combines transparency, expertise, and a shared commitment to help advance complex biologics from preclinical research to clinical success.

• 2nd Generation ATAD Provides High Quality Biosolids With Increased Capacity

  Modernize solids handling with automated aerobic digestion to manage rapid community growth. This high-rate process increases capacity, ensures Class A compliance, and significantly reduces disposal costs while providing odor-free operations through advanced nutrient and off-gas management.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• Keeping The Lights On With Wolfspeed SiC

  Introducing the “M” inverter, a modular, silicon carbide-based solution that optimizes utility-scale energy storage with higher efficiency, reliability, and scalability.

• Choosing The Right Platform: A Comparison For Regulated Industries

  Regulated industries depend on tightly controlled review workflows, yet common tools rarely meet those demands. Explore how purpose‑built solutions strengthen compliance and help streamline timelines.

• Restarting A Manufacturing Campus And Revitalizing A Community

  A high‑risk facility acquisition in Huntsville became a blueprint for revitalizing a modern pharmaceutical campus. Discover how coordinated action turned a massive shutdown into a renewed manufacturing hub.