Compliance and data integrity

Track compliance work throughout every experiment.

Keep a record of who did what, when it happened, what changed, and what result followed. These records can support ALCOA data integrity reviews, but software alone does not make a workflow compliant.

Review compliance workflows See regulated solutions

See who did what, when they did it, and why.

FDA guidance calls for records that are complete, consistent, accurate, linked to a person, recorded on time, and ready for review. Link actions, owners, times, results, file checks, and reviews to each run.

Teams can use this history to check reviews and prepare records for quality work or inspections. Each organization must still set up and validate those records for its own needs.

events

failed

review

tamper

09:42:16

Workflow execution started

workflowinfo

wf-flow-review-042

09:43:08

Analysis parameters applied

datainfo

analysis-v3.json

09:44:51

Output checksum recorded

compliancesuccess

sha256: 8c7a…9f2e

09:46:03

Operator review requested

compliancewarning

review / qc-director

Record detail

Actor: A. Mensah
Role: researcher
Category: workflow
Severity: info
Review: required
Tamper evident: yes
Change reason: parameter set approved
Event ID: evt_01J8QF

Customer review rules determine the final decision.

Attributable

Link each workflow action to the right user, role, session, and item.

Contemporaneous

Record workflow and audit events while the work happens.

Reviewable

Filter records, check their details, and prepare approved exports for review.

Data integrity

Keep data, details, and workflow steps together.

Link source files, file details, software versions, settings, scripts, changes, and processing steps. Workflow views make this information easier to inspect without replacing the original records.

Run details

Save times, users, software, file types, settings, and results.

Versioning

Track each workflow version and the software settings used for every run.

Checksums

Use checksums to help reviewers confirm that records and files have not changed.

Controls

Add reviews and access rules to the workflow.

Use approval steps, role-based access, backups, retention rules, and local deployment to control who can run, review, approve, and keep each workflow.

When your organization sets up and validates these controls, they can help teams show how decisions were made and procedures were followed.

Data location

Approved local folders

Public internet

Blocked

Controlled actions

Approval required

Credentials

Stored locally

Run records

Audit logging on

Backup policy

Customer managed

Before a run starts

3 / 3 checked

Software access follows approved policy

High-risk steps pause for a person

Run records stay with the workflow

Access controls

Use signed-in sessions and roles to control workflow access.

Review checkpoints

Pause the workflow for approval before a high-risk action.

Retention and backup

Use your own backup, retention, recovery, and export process.