Compliance

PRODUCTS

  • The AES modular cleanroom system is engineered with inherent flexibility to seamlessly incorporate essential modular cleanroom accessories while maintaining structural integrity and eliminating the need for costly engineering rework.

  • Germfree’s compliant modular compounding pharmacies offers non-hazardous and hazardous drug compounding within our established modular platform. It enables hospital pharmacies to manage surges, maintain patient support during renovations, and enhance efficiency with Germfree’s cutting-edge modular hospital compounding pharmacy.

  • Take control of your production by tracking every part, assembly, and batch with precision.

  • Discover how a team of biostatistics and pharmacokinetics experts can offer specialized guidance for clinical trial design and analysis.

  • Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity

    Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.

WHITE PAPERS AND CASE STUDIES

  • Graniterock Speeds Up Reporting From 7 Days To Real Time

    Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.

  • 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
  • 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.

  • 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.

  • TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
  • Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
  • Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant

    Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.

  • Ensuring On-Time Release Of CAR-T Cell Treatment In Spain

    Due to the COVID-19 pandemic, and the start of Brexit, a CAR-T cell treatment therapy shipment was offloaded multiple times by the airline, requiring an alternative transport solution.

  • AIIM Eyes Records Management In Government And Beyond At a recent advisory board meeting for ECM (enterprise content management) trade association AIIM, the hot, compliance-driven topic was electronic records management. Written by Tom von Gunden, Chief Editor
  • 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.

  • 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.

  • Medical Device Manufacturer Implements A Next-Gen MES

    A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.

NEWS