Compliance

PRODUCTS

  • Capture data at the true source: the patient. Improve the patient experience with secure, accessible questionnaires both via email and through the Castor Connect mobile application.

  • PHCbi brand’s 14.3 cu.ft. (406 L) microbiological heated and cooled incubator is designed to deliver precise, reproducible environments across a wide temperature range from -10°C to +60°C. Ideal for applications such as microbiology, food and cosmetic stability testing, plant cell culturing, and environmental studies, it supports programmable temperature and lighting protocols. The microprocessor PID controller helps ensures uniformity and stability, while the intuitive LCD interface allows for 12-step, 10-program memory with built-in alarms and backup. A forced air circulation system and energy-saving operation enhance performance and usability.

  • Eurofins PSS Insourcing Solutions delivers comprehensive manufacturing support that meets production goals with precision, compliance, and agility for biotech, pharmaceutical, and CDMO organizations. Our insourcing model places fully trained, managed scientific teams directly at client sites, enabling seamless integration into manufacturing operations while maintaining flexibility and long-term stability.

  • Create an aseptic workspace with Ecolab’s Bioquell Qube, a configurable isolator integrated with Bioquell Hydrogen Peroxide Sterilant*. From its unique design to rapid turnaround time, the Bioquell Qube provides the aseptic area you need to keep your research or production on track. 

  • Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

    Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

WHITE PAPERS AND CASE STUDIES

  • Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors

    Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.

  • Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
  • Remote ECG Solution Enables A Fully Decentralized ME/CFS Phase 2 Trial

    Explore the transformative potential of digital health tools in addressing longstanding accessibility challenges in ME/CFS research and beyond.

  • Client Story: Efficiency Enabling CSV At Scale

    Discover how Fujirebio Diagnostics digitized their global CSV processes to achieve a 53% time reduction in CAPA projects and streamline validation with remarkable efficiency gains.

  • Maximize Output From Full-Time Employees

    Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.

  • Improving Global Labeling Workflow

    One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

  • New EH&E White Paper Evaluates Web-based Environmental Health & Safety Training For Laboratory Applications A new free white paper entitled “The Role of Web-based Health and Safety Training in Laboratory Facilities,” is available to help companies, institutions, and universities evaluate the efficacy of using web-based environmental health and safety (EH&S) training to meet their compliance requirements
  • Catalent's Journey Of Continuous Improvement For CSV Excellence

    Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

  • How ABB's Flow And Digital Technologies Help Bawat With Smarter Ballast Water Compliance

    The International Maritime Organization (IMO) sets strict global standards for ballast water management to prevent the spread of harmful aquatic organisms. For companies like Bawat, a Danish innovator in ballast water management, being able to verify ballast water flow measurements quickly, accurately, and from anywhere in the world is essential.

  • Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
  • A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

    Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program.

  • DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint

NEWS