LabZila provides configurable controls for managing electronic laboratory records, user access, audit histories, reviews and electronic signatures. Connect these controls with samples, testing, quality processes, equipment and reporting while maintaining clear accountability throughout each regulated workflow.
Support controlled electronic records, traceable approvals and accountable laboratory workflows through configurable system controls.
Create, review and maintain laboratory records with defined statuses, permissions and complete activity histories.
Capture authorised electronic approvals with signer identity, date, time and configured signature meaning.
Record applicable changes, actions, comments and approvals with user attribution and timestamps.
Limit record access and system actions according to each user’s assigned role and responsibilities.
Route records through technical review, correction, approval and authorisation stages.
Maintain searchable electronic records and retrieve authorised copies throughout configured retention periods.
Support intended-use testing, controlled configuration changes and documented system-review activities.
Keep samples, results, methods, signatures and record histories connected for clearer traceability.
Manage laboratory records through controlled access, traceable activity, authorised review and electronic approval.
An authorised user creates or updates the required electronic laboratory record.
Required fields, permissions and workflow stages guide the record through the approved process.
Applicable entries, changes and actions are captured with user attribution and timestamps.
Qualified personnel review the record and apply the required electronic approval or signature.
Audit history retains applicable changes, comments, approvals and signature activity.
The approved record is finalised and remains available for authorised retrieval and retention.
LabZila provides configurable controls for electronic records, signatures, user access and approval workflows across connected laboratory processes. These capabilities can support a laboratory’s Part 11 approach when combined with appropriate validation, procedures, training and governance.
LabZila provides configurable controls for electronic records, signatures, user access and activity histories across laboratory environments. Part 11 applicability depends on whether FDA-required records are maintained electronically or electronic signatures replace handwritten signatures under the relevant predicate rules.
Manage electronic records through defined access, review, approval and retention controls.
Maintain user-attributed, time-stamped and traceable histories of applicable record activity.
Capture reviewer identity, signature date, time and approval meaning within the relevant record.
Automate assignments, reminders and approval routing across configured laboratory workflows.
Retrieve electronic records, audit histories, signatures and supporting evidence from one connected system.
A 21 CFR Part 11 LIMS is laboratory software that provides controls for electronic records and electronic signatures used in applicable FDA-regulated workflows. These controls may include restricted access, audit trails, electronic approvals, record protection and authorised retrieval.
No. LabZila can provide configurable technical controls that support a laboratory’s Part 11 approach, but compliance also depends on determining which records are in scope, validating the configured system, maintaining approved procedures, training users and governing access and signatures appropriately.
Part 11 generally applies when records required by FDA regulations are created, modified, maintained, archived, retrieved, transmitted or submitted electronically. Applicability depends on the relevant FDA predicate rule and how the laboratory uses the electronic system.
LabZila can support configured electronic review and signature workflows for authorised users. Applicable signed records should identify the signer, record the signing date and time and state the meaning of the signature, such as review, approval, responsibility or authorship.
LabZila can maintain time-stamped histories of applicable record creation, changes, actions, reviews and approvals. Part 11 closed-system controls call for computer-generated audit trails that preserve previously recorded information and remain available for authorised review.
A laboratory should validate the configured system according to its intended use and applicable requirements. Part 11 closed-system controls include validation to support accuracy, reliability, consistent intended performance and the ability to identify invalid or altered records.
Part 11 controls include protecting records throughout their required retention period and producing accurate, complete copies in human-readable and electronic formats suitable for authorised inspection, review and copying. LabZila can support searchable record access and retrieval according to its confirmed configuration.
Compliance is a shared responsibility. LabZila can provide technical controls for access, records, signatures and workflows, while the laboratory remains responsible for applicability assessments, validation, authorised roles, SOPs, training, retention policies and ongoing system governance.
Strengthen Electronic Record Control
See how LabZila can help your laboratory manage electronic records, audit histories, role-based access, controlled approvals and electronic signatures within one configurable LIMS.