Compliance

PRODUCTS

  • Bridge regulatory gaps in visual inspection and improve product quality by managing defects throughout the product lifecycle. Get a better understanding of how a centralized data repository can help.

  • For a nasal spray production fill-finish solution that offers unparalleled versatility, look no further! The Hull i-Dositecno BI and MI Nasal Spray Filling Machines simplify your manufacturing workflow to enable accurate and consistent rotary filling, stoppering and capping. With simple servo-driven motion-controlled design they can fill up to 50 or 200 units per minute (upm).

  • A strong risk and quality control strategy is essential to ensuring the safety, efficacy, and consistency of pharmaceutical manufacturing. By identifying and addressing potential risks early, we prevent costly errors and delays, ensuring smooth and efficient manufacturing of your products.

  • Immersion corrosion testing is a method used to determine the rate of corrosion of a test article, often a metal, in aqueous solution. Though this test can be used as an assessment tool for many applications, it is commonly used to evaluate the corrosivity of liquids.

  • 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

  • Validation Provider Shortens The Path To Equipment Qualification

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  • Liquid Handling Solutions For Bulk Drug Substance Management

    How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.

  • Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records

    Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

  • Sprint Helps Make Just About Any Place A Workplace

    Driving down costs to remain competitive can be a tough challenge for transportation companies, especially in the face of increased fuel and insurance costs. At the same time, customer expectations are rising.

  • White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.
  • Distribution Of The First Commercial CAR-T Therapy From USA To Japan

    Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.

  • Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
  • Ensuring Compliance With Part 11: A Site's Perspective

    As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.

  • Isn't The RFID Bandwagon Full? The RFID (radio frequency identification) space is a confusing market, and industry experts are not making it any more clear. Used with permission from Integrated Solutions Magazine
  • Software Automation In The Blood And Biologics Industry

    Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

  • Serialization And Traceability Compliance In Pharma And Med Device

    Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

  • Preparing For Post-Market Clinical Follow-Up Under EU MDR

    Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

NEWS