ZPD
As a pharmaceutical company, we have many manual and time-consuming processes. Now, a significant portion has been automated in IPW, leading to simpler and more transparent workflows.
While the extraction process itself is complex—extracting chondroitin sulfate from animal cartilage—the documentation is, if possible, even more complicated. The pharmaceutical industry operates under strict regulations to ensure compliance with cGMP, and all processes must be documented and approved to meet regulatory requirements from the Danish Medicines Agency, the Danish Veterinary and Food Administration, and general customer requirements.
Complete Validation of IPW – and Custom System Configuration
This is why it takes us longer than other industries to implement an electronic quality management system. Before getting started, we conducted an audit of IPW’s system validation. When developing forms, we must carry out risk assessments, a User Requirement Specification, a validation protocol, and a validation report. Even for updates, the system needs to be revalidated, and we must document how we test them.
With digital document management in IPW, documents are now easily accessible, simple to revise, and can be versioned and tracked. The forms provide an overview of deadlines and responsible parties. The system logs everything, ensures read-and-understood confirmations, and manages approval workflows—eliminating the need for paper-based approvals across multiple departments.
Everything in IPW Forms No Longer Exists in Paper Format
It’s great that we can tailor IPW exactly to pharmaceutical practices and configure it ourselves.
So far, we have set up forms for deviations, corrective actions, audits, supplier management, and incident reporting. Next up are change management, complaints, and OOS (Out of Specification) handling.
