Pharmaceutical companies need to assure the quality of their products and ourstanding 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.
K2Pharma module for Audit and Supplier
Qualification provides the following main features:
K2Pharma module for Audit and Supplier Qualification provides the following main features:
Audit / Qualification Planning
Management of methodologies and standard checklists
Management of standard checklist
Management of Reporting Templates
Risk Analysis tools
Management of audit/qualification scorecard, fully configurable according to company standard
Management of the Status of process and associated components (people/departments, systems etc.), as result of internal audits and/or supplier qualification
Workflows for qualification/audit execution and associated documentation (approval, follow-up etc.)
Reminders, monitoring tools and dashboards
The module also includes all required features to comply with Electronic Record and Signature Regulation (21 CFR part 11).
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