Audit Trail & Compliance
Complete traceability for regulatory audits
Immutable change history
Every change to a translation is immutably logged with timestamp, user identity, and reason for change. Subsequent manipulation is impossible — you always have a trustworthy record.
Regulatory audit reports
Generate complete audit reports at the push of a button for individual documents, projects, or time periods. Reports contain all changes, approvals, QA results, and comments in chronological order.
ISO 13485-compliant document control
manualworks meets ISO 13485 requirements for document control and record keeping. Versioning, approval workflows, and access controls are implemented at the system level.
How it works
Automatic logging
From the moment a translation project is created, manualworks automatically logs every action: document creation, segment changes, status transitions, comments, QA results, and approvals.
Versioning and comparison
Every document version is fully stored. You can compare any versions to see exactly what changed between two points in time — at the segment and character level.
Export audit report
When needed — for example, before an audit by a Notified Body — export the complete audit trail as a PDF report. The report contains a chronological documentation of all activities and can be presented directly as evidence.
Why Audit Trail Is Essential for Medical Device Translations
The EU Medical Device Regulation (MDR 2017/745) and ISO 13485 set clear requirements for document control and traceability. Translations of Instructions for Use are part of the technical documentation of a medical device and are subject to the same strict requirements for control, approval, and traceability as all other regulated documents.
During an audit by a Notified Body, you must be able to demonstrate: Who created the translation? Who reviewed it? When was it approved? What changes have been made since the last approval and why? Without a systematic audit trail system, these questions are difficult or impossible to answer.
How the Audit Trail Works in manualworks
manualworks automatically and comprehensively logs every action related to a translation. This begins with the project setup and translator assignment and encompasses every single segment change, every comment, every QA check, and every status change through to final approval.
Each audit trail entry contains four essential pieces of information: the timestamp (when), the user identity (who), the action performed (what), and, where applicable, the reason for the change (why). All entries are immutable — once written, they can neither be edited nor deleted.
Version Control at Document and Segment Level
manualworks offers two-tier version control. At the document level, every approved version is fully archived and can be retrieved at any time. At the segment level, the complete change history of each translation segment is accessible — from the initial AI draft version through translator adjustments and reviewer corrections to the approved version.
The integrated version comparison highlights differences between any versions in color. This is particularly helpful when you need to trace which segments were affected by a change request and how they were adjusted.
Audit Readiness as a Competitive Advantage
Companies that can present a complete audit trail at any time gain trust with Notified Bodies and accelerate the audit process. Instead of laboriously compiling evidence from various systems during an inspection, you generate a complete, professionally prepared audit report with manualworks at the push of a button. This not only saves time and stress during audits but also demonstrates a mature quality management process.
Frequently Asked Questions
Does the audit trail meet ISO 13485 requirements?+
Yes, the manualworks audit trail was specifically developed with the requirements of ISO 13485 for document control and record-keeping in mind. It captures all essential information that ISO 13485 Section 4.2.5 requires for control of records: who made which change, when, for what reason, and who approved it. All entries are immutable and timestamped.
Can audit trail data be exported for regulatory audits?+
Yes, manualworks offers extensive export functions for audit trail data. You can generate project-specific or document-specific audit reports as PDF that chronologically document all relevant changes, approvals, and comments. These reports are prepared so they can be presented directly as evidence during audits by Notified Bodies or regulatory authorities.