Compliance

WHITE PAPERS AND CASE STUDIES

• Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers

  This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.

• 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.

• Why Compliance-Driven CDMOs Win Sponsor Contracts

  Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.

• 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.

• 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.

• 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
• Continuous Flow — An Emerging Alternative

  Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

• 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.

• USP <665> Becomes Official On May 1, 2026. Are You Ready?

  With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

• Making Money With Security Awareness Training

  How addressing human error reduces risk and bolsters your profitability.

• InnovaGel Gains Quick Return On Investment

  InnovaGel, a manufacturer of vitamins and supplements in the nutraceutical and OTC market, was in need of solution for its soft gelatin encapsulation machine application.

• Software Automation In The Blood And Biologics Industry

  Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.