Data Integrity
Checklist
for Life Sciences
Data Integrity Checklist
Purpose
In the life sciences industry, maintaining data integrity Whether you are a novice or an experienced
is critical to ensuring data accuracy, consistency, and professional, this checklist will help you navigate
security. This document is designed to provide you the complexities of data integrity requirements and
with the knowledge and tools needed to uphold data implement effective solutions.
integrity practices, support quality assurance, and
ensure regulatory compliance.
Scope
This checklist has been designed following the Our Compliance Solutions checklist emphasizes
requirements essential for maintaining GxP (good Data Capture, Transfer, and Protection as part of the
practice) quality guidelines and standards. dedicated section on Computerized Systems.
This focus ensures a robust data integrity framework
Formulated in accordance with the FDA 21 CFR Part 11 for monitoring systems, thereby facilitating regulatory
and the EU GMP Annex 11 regulations, this guide aligns compliance, and maintaining the highest standards
with the structured guidance provided by the PIC/S. of quality.
Instructions
For each aspect, we present a checkpoint question. Simply provide a verification by marking the appropriate
response with a checkmark or indicating “Yes,” “No,” or “N/A” as applicable.
Data Integrity Checklist
SECTION
Data Capture
Data capture is the foundational step in maintaining data integrity. Accurate and reliable data capture ensures that
the information collected is precise, consistent, and ready for further processing. In this section, we will explore
best practices for sensor installation, calibration verification, and data review to ensure that your data capture
processes meet industry standards.
Aspects Checkpoints Completed?
Sensor Installation Is the correct model and serial number of the sensor installed, verified
and Validation against inventory records?
Sensor Installation Is the sensor located at the designated monitoring point?
and Validation
Sensor Installation Is the sensor securely fixed in place to prevent data variability?
and Validation
Calibration Does the calibration management SOP apply to the sensors used and
Verification is it approved?
Calibration Are calibration certificates reviewed for validity and proper storage,
Verification and cross-checked with supplier records?
Calibration Is there a current and valid calibration sticker on the sensor?
Verification
Data Review Is there an approved SOP for data review?
and Validation
Data Review Does the SOP specify responsibilities for data review and define
and Validation acceptable data standards?
Data Review Are procedures in place for handling data that does not meet the
and Validation established criteria?
Data Review Is the timestamp for each data entry synchronized with an approved
and Validation time standard (e.g., NTP server)?
Data Review Are measures in place to ensure that the timestamp cannot be altered
and Validation by unauthorized users?
Data Integrity Checklist
SECTION
Data Transfer
Effective data transfer processes are crucial for maintaining data integrity as data moves across systems and
interfaces. Ensuring secure and accurate data transmission prevents data tampering and loss. This section provides
insights into securing system interfaces, implementing encryption, and managing legacy data to maintain the
integrity of your data during transfer.
Aspects Checkpoints Completed?
System Interfaces Are data transfer interfaces secure and do they prevent data
and Data tampering?
Transmission
Security
System Interfaces Are data encryption and checksums in place to ensure data integrity
and Data during transfer?
Transmission
Security
System Interfaces Is there a protocol for maintaining system updates to ensure ongoing
and Data data accessibility?
Transmission
Security
System Interfaces Is the retrieval and integrity of the backed-up data periodically
and Data reviewed, and has the backup and restore functionality
Transmission been validated?
Security
Legacy Data Is there a comprehensive migration strategy in place for legacy data
Management that includes assessment, conversion, and validation protocols to
ensure data accuracy and usability in the new system despite initial
compatibility challenges?
Legacy Data Are old data formats compatible with new systems or is there a
Management conversion process in place?
Data Integrity Checklist
SECTION
Data Protection
Protecting data from unauthorized access and ensuring its integrity over time is vital for compliance and
operational reliability. This section covers access control measures, security protocols, and audit trail requirements
to safeguard your data. Implementing these practices will help you prevent data breaches and ensure that your
data remains accurate and secure.
Aspects Checkpoints Completed?
Access Control and Does the system require unique identification for each user?
Security Measures
Access Control and Are there protocols for user access levels and administrative
Security Measures task segregation?
Access Control and Are all data changes logged in a secure and comprehensive audit trail?
Security Measures
Access Control and Does the system lock-out the user after a defined number
Security Measures of unsuccessful login attempts?
Access Control and Does the system time-out after a defined period of user inactivity?
Security Measures
Data Security and Are electronic records produced in a non-editable format (.pdf) to
Integrity Protocols ensure integrity?
Data Security and Are physical and IT security procedures routinely reviewed and
Integrity Protocols updated?
Data Security and Is data backup performed regularly, with secure off-site
Integrity Protocols storage solutions?
Data Security and Are security measures in place to protect the system’s clock settings
Integrity Protocols from unauthorized changes?
Data Security and Is there a regular audit to verify the synchronization and protection
Integrity Protocols of timestamps?
Data Security and Does the system’s audit trail include detailed information for each
Integrity Protocols entry, such as the name of the user, the date and time of the event, the
previous and current value of the data, and a reason for the change?
Compliance and Are all related SOPs, including those for change management and
SOP Verification disaster recovery, current and inclusive of the monitoring system?
Compliance and Is there a regular review process for SOP compliance and
SOP Verification system readiness?
Data Integrity Checklist
By completing our Data Integrity
Checklist and assessing and addressing
these key points, you are proactively
taking the necessary steps to preserve
your organization’s data and to ensure
its accuracy.
Guaranteeing data integrity isn’t just about compliance;
it’s about making informed decisions, upholding
reliability, and mitigating risks. With Ellab’s continuous
monitoring solution your assets will be protected:
always be inspection ready while ensuring a timely and
quick response to any anomalies with our TrackView Pro
solution for continuous monitoring.
Read more about our continuous monitoring solutions
and find out how Ellab can help you with asset
preservation.
Follow Us
/ellab
/c/EllabValidationMonitoringSolutions
Ellab Benelux Ellab DACH Ellab Philippines
Tel. +31 74 205 12 34 Tel. +49 4286 92662 0 Tel. +632 621 9174
E: benelux@ellab.com E: germany@ellab.com E: ph@ellab.com
Ellab Denmark Ellab UK Ellab US
Tel. +45 4452 0500 Tel. +44 151 355 1314 Tel. +1 303 425 3370
E: contact@ellab.com E: uk@ellab.com E: usa@ellab.com
Ellab Dubai Ellab Ireland
Tel. +971 502049520 Tel. +353 801 3770
E: dubai@ellab.com E: ireland@ellab.com
Ellab A/S
Ellab France Ellab Italy Trollesmindealle 25
Tel. +33 344 2302 57 Tel. +39 02349 1751 3400 Hillerød
Denmark
E: france@ellab.com E: italy@ellab.com
www.ellab.com
