Quality Management


LOOKING FOR A QUALITY MANAGEMENT SYSTEM ?

Quality Managment 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 Quality Managment System calendar, with necessary documents, necessary email communications and esponsible 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, an email reminder is automatically sent. Once the corrective task is done, the CAPA is closed either by 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 workflowt

Automatic permissions for workflow statest

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 managment

QUALITY MANAGEMENT SYSTEM MODULE

PERSONNEL MODULE

TRAINING MODULE

INVENTORY MODULE

QUALITY ASSURANCE MODULE

DOCUMENT CONTROL MODULE

REPEATING QUALITY TASKS

SUBCONTRACTOR MODULE

PERMISSIONS MANAGEMENT

Is your business in a highly regulated industry? M-Files QMS is also ideal for:

  • Pharmaceutical and life sciences, including medical devices, biotechnology and clinical research organizations
  • Petrochemicals and other process-related manufacturing
  • Food production
  • Transportation, including aviation and automotive
  • Mining and more
  • Repetitive task automation
  • Automate and document recurring tasks and processes with comprehensive workflow capabilities and reminder notifications.

Quality assurance, audits and deviations

Manage audits and inspections, and efficiently record and process deviations and corrective actions.

Document Control

Organize and manage all quality-related documents, such as Standard Operating Procedures (SOPs) and Corrective and Preventative Actions (CAPAs), with complete version history, security, workflow and publishing.

Personnel

Assign role-based access rights and track experience and skills for employees and subcontractors.

Training

Manage course lists and materials, and record, track and report on training.

Inventory, lists, and registries

Build and manage company-specific inventories and lists, including software and hardware inventories, with full version history.

Signature management

When documents must be approved or authorized, M-Files QMS supports three signing options: built-in digital signing, external digital signing services and handwritten signatures.