Compliance

PRODUCTS

  • A Transfection Solution for Gram-Scale Protein Production

    The ExPERT VLx system delivers unmatched transfection scalability with MaxCyte's Flow Electroporation® technology for industry-leading reproducibility, flexibility and ease of use.

    • Reduce time, cost and risk
    • Transfect up to 200 billion cells, in a single-use system, in less than 30 minutes
    • Obtain grams of proteins in weeks, not months
    • Achieve reproducible results, superior transfection efficiency, cell viability and protein expression
    • Scale seamlessly to expedite your transition from discovery to Phase 1
    • Proprietary Flow Electroporation® Technology
  • Pharmaceutical labeling and kitting are critical for ensuring drug safety, compliance, and efficiency. Explore advanced technology and regulatory adherence to streamline these processes.

  • QPA1314 is a high-power GaN MMIC amplifier for Satcom applications. The amplifier is packaged for easy integration and is ideal for both commercial and military markets.

  • Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.

    They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.

    Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.

  • Specialized knowledge and expertise in information technology, quality assurance and laboratory practices is required to successfully implement and maintain laboratory projects and informatics systems within the pharmaceutical, biotech, chemical, food, and environmental industries.

WHITE PAPERS AND CASE STUDIES

  • Pharma Manufacturing: Top 10 Pitfalls To Avoid

    Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?

  • Leading European CDMO For Drug Product Manufacturing

    As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

  • Case Study: Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx
  • AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
  • A Survival Guide To Temperature Data In Life Sciences

    Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.

  • Have Confidence In Your Bio/Pharma Data

    The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing - which requires a new level of attention to detail. Learn what features tolook for when choosing a data management system to establish compliant data visibility across teams, sites and partners and establish data integrity throughout the product life cycle.

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • 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.

  • Advancing Compliance And Digital Strategy To Align With Pharma 4.0

    AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.

  • Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements

    A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.

  • How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives

    This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3

  • PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland

NEWS