Compliance

PRODUCTS

  • Implement Software Solutions that Support and Enhance Your Mission

    Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.

    As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.

  • 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. 

  • PHCbi brand's 8.4 cu.ft. (238 L) compact microbiological heated and cooled incubator is designed to helps ensure highly accurate, reproducible environments that mimic real-world conditions. It offers precise control of temperature, a low humidity setting, and lighting protocols - making it ideal for microbiology testing and research, food and cosmetic shelf life testing, municipal wastewater testing, plant cell culturing, and more. It is completely programmable, allowing for direct numeric input with memory of operation, start dates and hours, clock mode and timer.

  • The benchtop IJM NanoScaler system is designed for lipid nanoparticle R&D – allowing scientists to screen for the optimal process parameters for the formulation of API-containing lipid nanoparticles.

  • Electronic informed consent for patient-centric decentralized clinical trials.

WHITE PAPERS AND CASE STUDIES

  • 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.

  • Bertucci's Proactively Secures Its Point Of Sale Systems And Corporate Computers With Bit9 Whitelisting And Device Control

    Bertucci’s has become a beloved destination for Italian food since its formation in 1981.With more than 2,000 employees in over 90 restaurants, managing unauthorized software downloads on their growing computer systems became a daunting task.

  • Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
  • Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
  • 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.

  • 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
  • Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  • ARMA 2005 Show Highlights Refined Solutions For Records Managers The message to attendees of this year's ARMA show was to engineer an easy transition from paper-based files to electronic records management, supported with a clear and calculated plan. ARMA provided me a chance to sit down and talk with ECM vendors about the special offerings they had for solving companies' records management needs. Check out some of news and highlights from the manufacturers and software providers that were at the show.
  • Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

    The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

  • Set Up And Qualify GMP Laboratories

    See how a GMP microbiology lab was established and qualified in Ireland, providing expertise, staffing, training, and project management to ensure compliant operations and client success.

  • White Paper: The Impact Of The Internet On Compliance Education I sat with astonishment as the compliance officer of a large corporation told me that he had no idea what compliance education was being performed on a day-to-day basis within his organization. He went on to indicate that his company could not produce reliable documented evidence that its employees had in fact, completed federally mandated education
  • Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.

NEWS