Electronic Lab Notebook

Paper lab notebooks (ELNs) used in pharma and biotech R&D create data integrity risks. Unsigned entries, unreadable edits, delayed notes, and records that cannot be searched or safely stored.

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Scientist with gloves writing on an electronic tablet notebook
Laptop displaying structured scientific experimental templates

Structured Experimental Templates

Protocol and procedure templates

Standard procedures are saved as templates with fields for reagents, concentrations, instrument settings, and observations, ensuring structured data capture instead of free form.

Reagent and material traceability

Reagents and reference standards are chosen from the ELN inventory, linking each experiment to lot numbers, expiry dates, and certificates of analysis.

Cross-experiment search and reference

All experimental records are indexed and full-text searchable, letting scientists find previous methods or results in seconds instead of climbing through physical notebooks.

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ALCOA+ Data Integrity Compliance

Contemporaneous time-stamped recording

Every entry is timestamped when recorded and locked once made, meeting Contemporaneous and Original requirements without relying on scientists to recall work.

Correction and amendment workflow

Errors are corrected through an amendment workflow that keeps the original entry, logs the correction, and records the reason, ensuring original data is never hidden or deleted.

Compliant and enduring record guarantee

ELN records are saved to a continuously archive with documented back-up and recovery, meeting Complete, Enduring, and Available standards that paper systems cannot reliably achieve.

Close up of person electronically signing on a tablet with stylus

21 CFR Part 11 Electronic Signatures

Meaning of signature capture

Electronic signatures in our ELN capture signer identity, date, time, and purpose (Reviewed, Approved, Witnessed) meeting 21 CFR Part 11 Subpart C requirements.

Supervisor review and countersignature

Experimental entries route automatically for review and e-signature before finalization, ensuring QA oversight without the delays of physical signatures.

Signature audit trail

All signature events are logged in a tamper-evident audit trail with details of who, when, and by whom, providing a complete GxP-compliant signature history.

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