Compliance

WHITE PAPERS AND CASE STUDIES

• 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.
• 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
• Overcoming Obstacles To Deliver Critical Autologous Cell Therapy

  See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

• Electronic Informed Consent: Considerations For Implementation In Clinical Trials

  In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

• Tickford Engelhard Makes Catalyst Conform w/o Recalibrating An automaker in the Far East had a mature 2-L model that already met the U.S. transitional low-emissions-vehicle (TLEV) standards...
• LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
• 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.

• 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
• 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?

• 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.

• 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.