Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.
EZ BioPac is meeting the challenges of biopharmaceutical powder manufacture. The EZ BioPacsingle-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight.
If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.
Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.
The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure.
Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
The TrackWise by Sparta Systems Corrective Action and Preventative Action (CAPA) solution for the pharmaceutical and biopharmaceutical industries automates CAPAs precipitated by deviations, complaints, and other quality processes.