Electronic Records & Signatures
Electronic records and signatures built to support 21 CFR Part 11, with credential re-entry,
a reason for every signature, and each signature linked to the record it applies to.
Electronic records and signatures built to support 21 CFR Part 11, with credential re-entry,
a reason for every signature, and each signature linked to the record it applies to.
THE PROBLEM
Handwritten records mean crossouts, corrections, and entries that are hard to read and harder to verify. Quality teams describe auditors writing them up not for the science but for how the record looks, and a single audit finding can be what finally forces a system change.
Spreadsheets don't fix it. Once a value is in a cell, there's no reliable way to show who changed it, when, or why. For labs taking on regulated work, a system that wasn't built for Part 11 becomes the constraint on growth.
CAPABILITIES
Labbit is built to support 21 CFR Part 11 and EU Annex 11, with authenticated access, audit trails, electronic signatures, and record integrity controls, developed under a quality management system aligned with GAMP 5.
Administrators turn e-signatures on for the tasks that need them. Signers re-enter their credentials and choose a reason for signing, and their name, role, reason, and time appear on the task and in the audit trail.
Signing roles such as author, reviewer, and approver are assigned per environment. Independent review can be enforced, so no one can review or approve a workbook they contributed to, even if they hold that role.
Signed work is committed as a new revision. Labbit is designed so records are never overwritten: signatures stay permanently linked to the resulting record, and prior revisions remain intact.
HOW IT WORKS
01
Work is recorded in the task's workbook at the bench, as it happens. When the step is completed, it's committed to the record as a new, attributed revision.
02
When a task requires signatures, each required signer re-enters credentials and selects a reason. A signing summary shows which workbooks are waiting on an editor, reviewer, or approver.
03
Once the required signatures are complete, the workbook is committed and each signature is permanently linked to the resulting record revisions.
IN PRACTICE
ANALYTICAL QC
EBR, release and CoA generation
GMP BIOMANUFACTURING
Review by exception, not by binder
DIAGNOSTIC TESTING
PCR and molecular assays, validated flows
DIAGNOSTIC TESTING
Karyotype, FISH and CMA case management
Does Labbit support 21 CFR Part 11?
Yes. Labbit is built to support 21 CFR Part 11 requirements for electronic records and electronic signatures. Compliance itself is established by how a regulated company validates and operates the system, which is why Labbit provides IQ and OQ documentation and your team qualifies its intended use.
What does Part 11 require of electronic signatures?
Part 11 requires that each electronic signature be unique to one individual, that signed records show the signer's printed name, the date and time, and the meaning of the signature, that signatures be linked to their records so they can't be copied or removed, and that non-biometric signatures use at least two distinct components, such as a user ID and password. In Labbit, each signature records the signer, the time, their signing role, and a reason from a configurable list, requires credential re-entry at the moment of signing, and stays linked to the record revision it applies to.
How does Labbit support ALCOA+ data integrity principles?
Labbit's design supports each ALCOA+ principle. Records are attributed to the user who commits them, time-stamped by the system at commit, and stored as original, complete revisions that are never overwritten. Configured workflows keep data collection consistent, and every historical revision stays available for review.
Can we require signatures at specific workflow steps?
Yes. E-signatures are enabled per task, so administrators require them where your SOP calls for review or approval and leave them off administrative steps. Signing roles and signing reasons are configurable.
What security and privacy standards does Labbit meet?
Labbit has completed a SOC 2 Type 2 audit, supports HIPAA requirements for protected health information, and supports single sign-on and multi-factor authentication through your own identity provider.
RETIRE THE SIGN-OFF SHEET
We'll show you a review and sign-off inside a Labbit workflow, and what the
signed record looks like to an auditor.