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

Platform / Data Integrity

Data Integrity

Data integrity is at the heart of regulatory compliance in regulated environments. Every piece of data generated or handled must be reliable, traceable, and verifiable.

At GxpManager, data integrity is our top priority.

What is data integrity?

In the regulated sector, data integrity is crucial. It refers to the reliability and accuracy of data throughout its lifecycle. This means that data must be:

  • Complete: All necessary data must be present.
  • Consistent: Data must be coherent across records and systems.
  • Accurate: Data must be error-free and faithfully represent what they are intended to.
  • Original: Data must be the initially collected information, without manipulation or falsification.
  • Attributable: It must be clear who recorded the data and when.
  • Legible: Data must be clear and easy to understand.
  • Contemporaneous: Data must be recorded at the time the event occurs.

Data integrity is a fundamental pillar of regulatory compliance (FDA, EMA, ANSM, ISO, etc.).

compliance icon
Conformité

The risks of tools that do not comply with data integrity

Using tools that do not ensure data integrity exposes your organization to major regulatory and operational risks.

CategorySpecific RisksGxpManager
Regulatory❌ Non-compliance with requirements (FDA, EMA, ANSM…)
❌ Warning, penalties, failed audits
❌ Rejection of regulatory submissions
✅ Native compliance with ALCOA+, 21 CFR Part 11, Annex 11
✅ Validatable and audit-ready platform
Quality❌ Altered, incomplete, or deleted data
❌ Incorrect decisions based on unreliable data
❌ Product risk (non-compliance, inefficacy, hazard)		✅ Complete audit trail
✅ Electronic signatures
✅ Secure & traceable data
Cybersecurity & IT❌ Untracked modifications
❌ Uncontrolled access – data loss or corruption
❌ Lack of backups or traceability		✅ Granular access control
✅ Timestamped audit log
✅ Automatic backups & secure cloud storage
Organizational❌ Project, audit, or production delays
❌ Remediation costs (time, money, resources)
❌ Loss of trust from partners and authorities		✅ Rapid digitalization
✅ Reduced errors & delays
✅ Real-time data availability
GxpManager: A system built on data integrity for 100% compliance

Don’t let non-compliance or uncertainty put your data, audits, or reputation at risk.

Choose GxpManager—the platform designed to ensure 100% integrity, traceability, and compliance across all your business processes.

Take control of your data traceability today!

How does GxpManager help you ensure
the integrity of your data?

In a regulated environment, data traceability goes beyond simply knowing where data is stored: you must be able to reconstruct its history, identify every action, and demonstrate consistency between requirements, results, and approvals.

With GxpManager, every data point is created, tracked, validated, and archived within a system designed to provide total, automated traceability—fully compliant with regulatory requirements and audit-ready at all times.

Traceability Matrix

Visualize, structure, and link all critical data: requirements, tests, results, specifications, documents, and regulatory references.
It provides a real-time global view, simplifies the management of relationships between elements, and ensures complete and verifiable coverage.

Electronic Signature

Secure every approval by ensuring both the signer’s authenticity and the data’s integrity.

Each change is attributed, timestamped, and protected against any alteration.
It serves as indisputable proof of consent.

Audit Trail

Automatically track every creation, modification, or deletion—along with the author, date, and justification—for complete visibility and flawless traceability.

Dashboard & Reports

Track your key indicators in real-time and generate clear, actionable, audit-ready reports with a single click.

Automated Workflows: Process Traceability

Every step of your business process is tracked, ensuring not only traceability but also precise monitoring of task progress.

One-click Publishing

Generate and share customized reports based on your validated templates—effortlessly and error-free.

Take control of every link in your data chain!

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