QMS & POPIA
Quality and Compliance & GDPR (POPIA) Compliance
Your company produces products with rigorous quality and compliance requirements. Managing a quality system, including standard operating procedure approvals, training records and tracking pending CAPAs, can be daunting and resource-intensive. M-Files makes it easier to improve your quality management system, stay compliant and move through audits using document and process management capabilities designed for organisations with strict quality and compliance needs.
Reduce Regulatory Risk
Maintain Control Over Compliance Requirements
Reduce Regulatory Risk
Failure to comply with regulations is expensive and risky. From ISO 9001 to FDA 21 CFR Part 11, M-Files helps you stay compliant by organizing, recording and automating processes across your business.
Traceability and Transparency for Pending Tasks
Non-conformances and audit findings can be costly if problems are not clearly identified. M-Files enables you to track assigned actions by audit, department, workflow state or other defined properties. Real-time visibility into CAPA states and related documentation updates keeps corrective actions from being overlooked.
Automate Quality Processes
Access detailed system views and reports. Escalate pending actions and receive instant notifications about changes. Monitor assigned document learning tasks and issue actions to mitigate identified risks. Every action is stored in an audit trail. M-Files automates workflows such as change control, CAPAs and training.
Disseminate Up-to-Date Policies and Procedures
In M-Files, there is only one version of every document. Quality and compliance documents remain current and accessible.
Benefits
Training
Manually managing staff learning requirements, training certifications from internal and external sources and other training tasks is a time-consuming process. M-Files automates training-related activities and workflows and enables you to easily manage course lists and materials, as well as record, track and report on training.
Lifecycle management
It’s important that everyone in your organization is up to speed with regard to processes, procedures and policies. M-Files allows training assignments to be created, completed and tracked seamlessly. From orientation to new skill development, ensuring employees are trained and prepared is vital for success.
Find what you need instantly
Manually managing day-to-day processes isn’t a good use of your time. M-Files automates training-related workflows like ensuring that the entire shop floor staff has read updated process instructions. Ensure consistency while M-Files helps you verify that your business processes are followed.
Access anything from any device
What if everyone in your organization could find the right information quickly? In M-Files, there’s only one version of every document. No matter what type of quality or compliance document is needed, it’s always current.
Protect sensitive data
One of the biggest challenges of deploying a new system is getting everyone to use it. With M-Files, user adoption is never a problem because it conforms to how you work. Manage training documents, information and processes without having to crack a user manual. It’s intuitive, integrates with many standard business systems and it just works.
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