In fast-evolving research and manufacturing landscapes, maintaining data integrity is more important than ever. Regulatory compliance, product quality and patient safety depend on the reliability of your data. Yet, manual processes, incomplete records and noncompliance remain significant hurdles.
Automated, fit-for-purpose tools overcome these challenges to ensure consistency, accuracy and completeness in your data workflows.
This infographic highlights strategies for managing lab data effectively to help researchers and manufacturers achieve regulatory compliance.
Download this infographic to explore:
- Key challenges threatening data reliability and compliance
- The benefits of automation for ensuring complete and trustworthy records
- Essential tools for secure data management and audit readiness
The Path to Rock-Solid Data Integrity
Building Credibility into Scientific Research
and Pharmaceutical Manufacturing
Data integrity is crucial for
achieving reliable outcomes.
It supports regulatory
compliance, product quality,
and ultimately, patient safety.
What is Data Integrity?
Automating Compliance
Modern lab devices simplify data integrity compliance by
replacing manual, paper-based procedures with automated
technical controls.
Quality
Data is accurate
and precise
Trustworthiness
Data is recorded
correctly
Reliability
Data is consistent
and dependable
Completeness
Data contains all
required elements
1
3
2
4
FDA Targets Data
Integrity Violations
• Data loss or manipulation
• Improper batch documentation
• Insufficient audit trail
• Procedure noncompliance
• Incomplete data transfer
• Loose paper data
* Chart data published in 2021 article
% Drug GMP Warning Letters
Citing Data Integrity Violations
Canada
India
Japan
USA
China
S. Korea
97
78
71
69
65
50
Audit Trail &
Alibi Memory
Secure Data Backup
Safe Data Transfer
Access Control &
User Management
Electronic
Signatures
Time
Synchronization
Connected Solutions
Cubis® II Lab Balances
• 21 CFR Part 11,
EU Annex 11 compliance
• Complete traceability
• Submission-ready data
• User management controls
• SOP integration
Ingenix Suite
Digital Fleet Management
Electronic Picus® 2 Pipettes
• Open connectivity
• Bluetooth-enabled
• Password protection
• Calibration reminders
• Pipetting app
• External balance calibrations
and weight set management
• Open software solution
• ALCOA+ principles; 21 CFR 11
and EMA Annex 11 compliance
• Pipette performance
checks and calibrations
Find out more:
Ingenix Suite Lab Data
Management Software