LOOKING FOR A QUALITY MANAGEMENT SYSTEM ?
Quality Management System (QMS) makes it easy for businesses to improve their quality management systems and meet certification requirements with document and process management capabilities designed for organizations with strict quality and compliance needs.
Manage all types audits and inspections including external audits by clients, regulatory bodies or certifying organizations, subcontractor audits and internal audits. Each audit becomes a timed event in the Quality Management System calendar, with necessary documents, necessary email communications and responsible people.
Record and manage all kinds of issues, audit findings, quality deviations and near-miss situations together with necessary information such as severity (major, minor, etc.), area of issue, description of the problem, recommended corrective action(s), and responsible people.
Record and follow up all the corrective and preventive actions (CAPA). Each issue goes in its own processing workflow during which it is assigned to a responsible person, appears on the person’s to-do list with a due date, and an email reminder is automatically sent. Once the corrective task is done, the CAPA is closed either by a responsible person, QA manager or both, depending on company policy.
KEY FEATURE OF QUALITY MANAGEMENT SYSTEM
- Major and minor versions with full version history
- Effective template management
- Automatic conversion of MS Office documents to PDF when finalized
- Watermarking and header/footer labeling during document workflow
- Automatic permissions for workflow states
- Enforced predefined naming conventions
- Enforced automatic document numbering
- Document lifecycle management and periodic review workflow
- New document request and document’s change request
- New document request and document’s audit findings and version management
QUALITY MANAGEMENT SYSTEM MODULE
- PERSONNEL MODULE
- TRAINING MODULE
- INVENTORY MODULE
- QUALITY ASSURANCE MODULE
- DOCUMENT CONTROL MODULE
- REPEATING QUALITY TASKS
- SUBCONTRACTOR MODULE
- PERMISSIONS MANAGEMENT
QUALITY MANAGEMENT SYSTEM: TOP FEATURES & BENEFITS
- Quality standards such as ISO 9001
- Compliance with FDA 21 CFR Part 11 and EU GMP Annex 11