Range IT

Quality Management Systems (QMS)

M-Files QMS: Meet customer expectations, foster continuous improvement, and sustain the company's reputation.

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Why Choose Us for Compliance and QMS

Navigating the complexities of compliance and quality management is a monumental task. We offer a holistic, certified solution that not only makes compliance manageable but turns it into a strategic advantage for your organisation.

Deviations and CAPA Processing: Quick and Effective Solutions

For deviations from set standards, our Corrective and Preventive Actions (CAPA) system quickly sets a plan in motion to bring operations back to compliance.

Customer Feedback Processing: Your Customer's Voice Amplified

Customer feedback is not just data; it’s a goldmine of actionable insights. We provide the tools to process this feedback and integrate it into your QMS for ongoing improvements.

Digital Signature: Secure and Compliant

Every action in your QMS can be digitally signed for enhanced security and traceability, in compliance with laws like FDA 21 CFR part 11 and Eudralex Vol 4 Annex 11.

Certified Compliance and Security: ISO and SOC Certifications

We’re proud to offer an ISO and SOC certified QMS, compliant with ISO/IEC 27001:2013, SOC 2 and SOC 3, ISO 9001:2015, GDPR, ISO/IEC 27017:2015, ISO/IEC 27018:2014, ISO 22301:2012, and more.

Records Management: Compliance Across the Board

We adhere to international records management standards like SÄHKE2, DoD 5015.2, MoReq2, as well as compliance with FDA 21 CFR part 11, Eudralex Vol 4 Annex 11, HIPAA, SOX-404, and FIPS 140-2 Level 2.

Document Control: The Spine of Compliance

Document control is the cornerstone of any robust QMS. Range IS offer advanced solutions for managing and storing your important documents in a safe, searchable, and regulated environment.

Change Management: Adapt with Confidence

We take audits seriously. Our system allows you to schedule, perform, and follow-up on audits effortlessly. Critical findings are flagged for immediate attention to ensure compliance and continuous improvement.

Audits and Findings Follow-Up: Proactive Correction

We take audits seriously. Our system allows you to schedule, perform, and follow-up on audits effortlessly. Critical findings are flagged for immediate attention to ensure compliance and continuous improvement.

Repeating Quality Control Tasks: Consistency is Key

Our system automates the tedious yet crucial tasks in quality control, ensuring that your products or services maintain a consistent high quality.

Quality Manual: Your QMS Bible

Our comprehensive quality manual is your go-to guide for every process, responsibility, and procedure that forms part of your QMS.

External Documents: Integrated Seamlessly

All external documents, whether from suppliers or regulatory bodies, are managed and integrated into your QMS for complete traceability.

Training Documents: Equipping Your Team

Compliance begins with the right education. We provide updated training documents, ensuring that your team is well-equipped to maintain quality and compliance standards.

QMS Validation: Ensuring System Integrity

Our solutions go through rigorous validation procedures to ensure that they meet all industry-specific regulations and standards.

Process Maps: Visualising Success

A picture is worth a thousand words. Our detailed process maps offer a visual representation of your QMS, enhancing understanding and implementation.

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