Quality Events
Quality Events
Deviations, complaints, audit findings or training gaps are part of everyday life in pharma and biotech – the real question is how efficiently you deal with them. Docuply Quality Events consolidates all your deviation and CAPA management in one intuitive digital workflow: nonconformances, OOS, product quality complaints, supplier nonconformances, labelling/packaging errors, equipment failures, data integrity incidents and training gaps – everything is captured, assessed and tracked in a structured way.
For each quality event, you define one or more CAPA plans with as many CAPA actions as required, each of which can be managed, documented and closed out separately. This reduces media breaks and makes your quality work transparently traceable and inspection-ready.
The game changer: Docuply links your quality events with relevant documents and uses AI to propose root-cause indications and suitable CAPA actions – including realistic deadlines based on historical timelines. This transforms scattered individual cases into structured, prioritised action packages, helping you save up to 80% of the time currently spent on root-cause analysis and CAPA creation.
Experience in the live demo how you can move from a patchwork of Excel files, emails and Word templates to modern, scalable quality event management – without months of implementation projects.
- All quality events in one place: non-conformances, OOS, PQR and product quality complaints, audit and inspection findings, and much more
- Flexible CAPA plans with multiple actions: Any number of CAPA actions per event, each individually assignable, trackable and assessable
- Directly link documents and training courses: connect SOPs, batch records, training certificates or audit reports directly with deviations and CAPA plans
- AI-supported root cause analysis: Root cause suggestions based on event data and linked documents result in time savings of up to 80%
- Intelligent CAPA suggestions: AI suggests specific CAPA actions with realistic deadlines, prioritised according to quality impact
- End-to-end traceability: Complete timeline from the event to the root cause to the effectiveness check
- Reduced preparation for audits and inspections: clear, consistent documentation of all quality events
- Developed for pharmaceuticals and biotech: Tailored to the GxP requirements of pharmaceutical SMEs, biotech start-ups and CROs in regulated environments
Book a live demo and see how Docuply uses AI to generate root cause suggestions and derive concrete CAPA actions with realistic deadlines. This saves your team up to 80% of their time and ensures that your quality events are documented and audit-ready at all times
Testimonials
What experts say about us
“Many companies struggled with isolated IT solutions and the major challenge of how to use or adapt established IT systems to interact with an increasing number of external business partners while also complying with regulatory requirements. The young start-up Docuply offers a very simple yet flexible solution for this, which is ready for immediate use thanks to its cloud architecture.”
