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 of Audit :
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 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 Features 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 Modules
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