Compliance

PRODUCTS

  • PHCbi brand's 24.2 cu.ft (684 L) upright pharmacy refrigerator offers a practical solution for storage with adjustable shelves and a wide setpoint range for varying laboratory applications, including biomedical storage and processing. The interior layout makes it ideal for running experiments that require changeable shelf configurations. The shelves can be arranged to accommodate all heights, and deep and strong enough to hold processing equipment and most devices.

  • Change how you compete by getting the clinical data services and support you need. Medrio is here to help clinical trial sponsors and CROs build internal expertise and support any clinical trial data management needs.

  • 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.

  • Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems.

  • This easy-to-use process analytical technology device offers in-line bioprocess analysis and control with no complex modeling. Measure multiple critical parameters across media, across processes, across mammalian cell lines, across scales.

    All In-line Gain, No Modeling Pain

    MAVERICK is powered by Raman spectroscopy and a purpose-built de novo model. The de novo model is explicitly built on media chemistries and device physics, not on empirical data. It automatically interprets the spectra and quantifies process parameters enabling simultaneous measurements of glucose, lactate, and total biomass. This is achieved without the costs, complexities, and risks associated with conventional Process Analytical Technology (PAT) methods. There is no need to grapple with complex empirical models, reagents, or unreliable auto-sampling systems to implement in-line bioprocess analysis.

WHITE PAPERS AND CASE STUDIES

  • 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
  • Sporting Goods Retailer Takes Safety And Product Testing To A New Level

    This U.S.-based retailer is an omni-channel sporting goods powerhouse offering a broad assortment of top-brand sporting goods equipment, apparel and footwear. They operate 645 locations with a blend of dedicated associates, in-store services and unique specialty shop-in-shops. As a producer of reliable, high-quality products that their loyal customers have come to expect, product safety and compliance are major focuses for this sporting goods retailer.

  • How To Survive An FDA Audit

    Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

  • Virtual Study Yields High Compliance & Retention Rates

    Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

  • 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.

  • AIIM 2004: In Comes Compliance, Out Goes The Cash As he made the rounds at AIIM Expo 2004, Chief Editor Tom von Gunden found vendors offering — and end users ready to buy — ECM, BPM, and ILM solutions targeting compliance-driven needs.
  • Managing Hospitality And Entertainment Spending The ability for hospitality and entertainment enterprises to effectively source, procure, and manage their spend must keep pace with the demand for promptness and compliance in supplier relationship management (SRM). Submitted by Epicor Software Corporation
  • 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.

  • 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.

  • 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.

  • Case Study: 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
  • 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.

NEWS