Records Management

WHITE PAPERS AND CASE STUDIES

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Leeton Shire Improves Efficiency And Service Levels With An Affordable, Intuitive Digital Solution

  Although Leeton Shire already had some digital technologies in place, such as SCADA, GIS and AMI, they lacked hydraulic modeling capabilities and expertise — which is why they turned to Qatium’s open and secure water management platform.

• Optimal COA Measurement Strategy In Modern Oncology Trials: Insights

  Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.

• 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.

• Monitoring Laser Power Helps This Biopharmaceutical Company Comply With Governmental Norms

  Explore how a custom-integrated solution helped a biopharmaceutical company meet strict government regulations while optimizing the performance and accuracy of their fill and finish measurements.

• Increase Production Capacity With Virtualized Process Automation

  Learn how Sleeman Breweries grew their production, improved process control, and avoided the high expense of building a new greenfield facility.

• 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.

• Calculating Your Business Case For Continuous Manufacturing

  Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.

• Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

  Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

• Global EPCMV Firm And Cleanroom Vendor Deliver cGMP Virotherapy Facility

  A global EPCMV firm worked closely with a cleanroom vendor to deliver a manufacturing facility that meets guidelines for BSL2–Large Scale. Learn about the facility, the companies involved, and more.

• Key Considerations For Selecting A Solenoid Valve In Health & Science Applications

  Solenoid valves are vital in medical devices, enabling precise fluid and gas control. Explore customizable, high-reliability valves that optimize performance while conserving space, weight, and power.

• Orbal® System for Biological Nutrient Removal

  Discover how a fast-growing community's new WWTP meets new tighter limits on ammonia, phosphorus, and nitrogen for future growth.