GMP Compliance

Deficiencies in QMS systems in general and the CAPA process in particular make up a significant portion of FDA 483s (documented findings reported from FDA inspections) and warning letters. By some estimates, 30% to 85% of 483s and warning letters are directly related to Corrective and Preventative Action (CAPA) processes. The NextDocs QMS Module is designed around GMP compliance and can help you manage deviations, audits, complaints and other sources of quality issues, wrapped into a closed-loop solution with CAPA. Forms-driven workflow allows data to be collected for reporting, metrics and dashboards. Automatic notifications and escalations meant that the process remains in a state of control.

SOPs remain a significant source of audit findings as well, with The European Medicines Agency’s most recent inspection summary still finds “Documentation - quality system elements/procedures” as the most common category of GMP deficiencies, found in 10.9% of all inspections. The NextDocs SOP Module provides standardized process for the creation, review, approval and modification of SOPs and other procedural documents. Associated training functionality means that people using the documents will be prompted to complete assigned training activities – whether they are new to the department or just need to learn about a procedure that is being modified. Automated periodic review notifications and workflows help to maintain a state of compliance and prevent the common audit finding where a company fails to comply with its own periodic review policies.