Compliance

WHITE PAPERS AND CASE STUDIES

• The Importance Of Quality In Raw Material Selection

  Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization. 

• The Potential Return On Investment Of Using ePROs Over Paper In Clinical Trials

  Industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as 10 times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention and compliance, and study and site efficiency.

• USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them? Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods. Submitted by Shimadzu Scientific Instruments
• Cabrini Health Experiences Improved Operational Efficiency And Other Significant Benefits With triCerat

  Cabrini Health is a not-for-profit Catholic healthcare service with 3,800 employees and over 700 beds comprising of two acute care hospitals, a palliative care service, rehabilitation hospital, residential care facility, and pharmacy department.

• Successfully Delivering Critical Stem Cell Samples Across The Globe

  To deliver multi-leg shipments of crucial stem cell samples on-time and within specifications, samples had to be collected from Japanese apheresis treatment centers and transported to a USA manufacturing plant within 24 hours.

• Hyland Software Customer Rochdale Metropolitan Borough Council Presents At Butler Group Enterprise Content Management Symposium In London Hyland Software, Inc., developer of the OnBase enterprise content management (ECM) software suite, announced that Hyland customer Rochdale Borough Metropolitan Council presented a case study regarding its installation of OnBase at the Butler Group Enterprise Content Management Symposium.
• 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.

• Security In The Supply Chain

  When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

• 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?

• Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner

  In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.

• 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.

• Safeguarding The Viability Of Pharmaceutical Samples Within 42 Hours

  The distribution of critical cell samples requires an agile strategy with contingency planning and regulatory expertise to ensure seamless delivery on-time and within specifications.