Document management and Digital Batch Record
Your floor only runs on the effective, approved version.
SOPs, forms and the master batch record all follow the same controlled lifecycle: request, review, signature, distribution, effective date and retirement. Anything that isn’t effective never reaches the floor.
What it does
From draft to the floor, every step signed.
The DMS governs the lifecycle of every GxP document, including the master batch record executed on the floor.
Digital Batch Record
- Master batch record design with variables, task groups and calculations
- Every master version goes through review, approval and signature in the DMS
- Completed records, document packages and batch record consolidation
- Assignment of forms to plant-floor devices
Document lifecycle
- Numbered requests to create, revise, withdraw or reinstate documents
- Approval workflows in a visual BPMN designer, with due dates, reminders and escalation
- Official code on approval, change history and side-by-side version comparison
- Delegation: a stand-in signs “on behalf of”
Distribution and use
- Required reading with per-version acknowledgement and comprehension quizzes
- Controlled printing with watermark and “Copy X of N”
- Form-type documents that are filled in, autosaved and signed
- Process maps as controlled documents
Everyday work
- AI writing assistant: the author reviews every suggestion before inserting it
- Full-text search, saved views and Excel export with your choice of columns
- External documents with expiry dates and obsolescence records
- Multilingual interface
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
A document-type change control opens the request in the DMS, and training is measured against the effective version.
LIMSLaboratoryAnalytical methods link to their controlled document.
EQEquipmentQualification protocols link to an effective document.
VLComputer system validationValidation evidence is stored in the document repository.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- 21 CFR Part 11
- E-signatures with meaning, a second factor and records that cannot be altered once signed.
- EU GMP Annex 11
- Complete audit trail of every document’s lifecycle.
- ISO 9001 §7.5
- Control of documented information: approval, versioning, distribution and retirement.
- ALCOA+
- Attributable, dated records protected against change.
See how an effective master reaches the floor.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.