Compliance

WHITE PAPERS AND CASE STUDIES

• 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
• An Equitable Way To Meet On-Site Business Needs

  Tackling high turnover and employee equity challenges is a priority. Learn how an on-site insourcing solution can provide a stable and motivated team, ensuring project success.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• 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.

• 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.

• 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
• Demanding More From AI Governance In Drug Safety

  Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

• 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.

• 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
• Analytical Procedure (Method) Lifecycle Management Drives Method Development At Innovative CDMO

  A global CDMO proactively adopted MLCM and AQbD methodology to help their customers gain efficiencies, and improve the quality of their drug products, and the adoption of UPLC and PDA/QDa technology has contributed to its success.

• 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