K2C QMS - Audit Management Solution

Pharmaceuticals and other regulated organizations need to assure the quality of their products and outstanding processes also by internal audits and supplier qualification. Internal audit should be performed in order to periodically verify internal quality standard, meeting of regulation requirements and the appropriate application of company Quality System and SOPs (Standard Operating Procedures). Supplier Qualification is required to ensure an appropriate quality level of any vendor of GxP critical furniture, here including producer of raw materials, equipment, instruments, spare parts, utilities and computerized systems. In addition, Pharmaceuticals need to handle some specific kind of audits to verify Clinical Study Sites, documentation or other special matters.

K2C Audit modules include:

• Supplier Qualification Audits
• Process Audits
• Clinical Site Audits
• Documental Audits
• Received Audits

Each audit module provides the following main features:

• Audit Planning tools, automatically proposing a risk-based scheduling
• Management of standard templates for audit report, agenda and checklists
• Risk Management tools
• Management of Qualification Status or audit outcomes
• Management of CAPA (planning, execution and final assessment) fully traced with finding observed during audits
• Reminders, monitoring tools and dashboards
• Charts and Metrics, ensuring a full Governance of audit activities and outcomes