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.
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
K2C can offer you the highest ROI for 2 simple reasons: it is the cheapest solution with the wider and smarter set of features!
K2C Audit Solutions also include K2C eSignature and other feautres required to comply with Electronic Record and Signature Regulations.