How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

sector

Laboratories

It’s time to move on from Excel® files, paper forms, and endless manual procedures.
In a highly regulated environment, every error, oversight, or untracked data point jeopardizes traceability, quality, and data integrity.

Challenges related to the use of spreadsheets and paper-based procedures

The use of Excel® files, paper forms, and manual procedures is still common in many laboratories. However, these methods quickly show their limitations:

  • Scattered data that’s hard to locate, reducing visibility and efficiency.
  • High risk of errors due to repeated manual handling.
  • Unsecured data with no traceability or integrity assurance.
  • Lack of analysis and monitoring, with KPIs difficult to leverage in real-time.

These weaknesses lead to slower response times, significant time loss, and an increased risk of non-compliance with regulatory requirements. Ultimately, the lab’s competitiveness is at stake.

Une plateforme conçue pour les laboratoires exigeants

A comprehensive solution designed to address the key challenges faced by laboratories:
traceability, data integrity, security, and regulatory compliance.

  • Centralize all your data in a digitized, secure, and structured environment
  • Track every action with a complete, reliable, and timestamped history
  • Reduce errors through process automation
  • Simplify audits and ensure compliance with regulatory authorities

Digitalization of analysis sheets

Digitalisation de tableurs

From analysis sheets to spreadsheets

Laboratories handle critical data every day using Excel® files or paper forms. These formats, often lacking security and traceability, no longer meet today’s regulatory standards.

Digitalization ensures complete traceability, enhanced data integrity, and easier compliance with standards and audits. It empowers laboratories to improve efficiency, reliability, and peace of mind in their daily operations.

With GxpManager, analysis sheets and spreadsheets are fully digitalized within a compliant and secure platform:

  • Guided data entry through preconfigured, conditional, or mandatory fields.
  • Customizable workflows with review, approval, and electronic signature.
  • Integrated automatic calculations to prevent manual errors.
  • Secure archiving with PDF/Word export.
  • Data import available from Excel® files or connected instruments.

Our applications for
Laboratory Managment

Tailor-made or ready-to-use, our applications meet the needs of laboratories.
Our solutions can integrate with your existing tools to boost productivity!

eQMS: Compliant, centralized, and audit-ready quality management

Laboratories must rely on reliable, compliant, and easily auditable quality management systems to minimize non-compliance and effectively manage and share corrective actions.

Centralize all your quality processes on a single, intuitive platform:

  • Complete traceability (audit trail): Track every change to ensure the integrity and consistency of regulated data.
  • Audit management: Prepare for and manage internal and external audits with confidence.
  • Document control: Organize, validate, and publish your quality documents.
  • Quality actions: Manage non-compliance, complaints, CAPAs, and change requests.
  • Training tracking: Ensure your teams are trained and qualified in real time.

GxpManager Platform:
The Power of traceability, security, and compliance

Healthcare leaders have trusted GxpManager for over 20 years!

A software editor since 2003, GxpManager leverages its industry-specific applications developed for the life sciences sector. This translates into deeply understanding our clients’ regulatory and operational challenges. We offer application templates that quickly adapt to their needs and fully customized solutions.

GxpManager is a compliant application platform that is available through an annual subscription. It’s an agile platform that allows you to create applications tailored to end-user needs through collaborative work.

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Traceability

Compliance icon GxpManager

Compliance

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Security

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Agility

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