dms

Document Management System

One version. One truth. Always.

Stop the version chaos. SOPs, policies, and controlled documents with automated workflows, training integration, and complete audit trails. The foundation your quality system needs.

Document Management System

The $180,000 laminated copy

The operator opens the SOP on their workstation—version 3.1, the one they printed last month and laminated for the clean room. The procedure says to add Excipient B at 45°C. They add it at 45°C. The batch fails.

Nobody told them about version 3.2. It was approved three weeks ago. The temperature window changed to 42°C based on process optimization data. The updated SOP was uploaded to SharePoint. An email went out. But the laminated copy on the production floor still says 45°C.

This batch cost $180,000. The investigation took two weeks. The 483 observation read: "Failure to ensure that production personnel have access to the current version of applicable procedures."

Root cause: document control failure.

Version Chaos vs Single Truth

The archaeology of your own documents

Open any shared drive in any life sciences company. You'll find:

  • SOP_Cleaning_Final.docx
  • SOP_Cleaning_Final_v2.docx
  • SOP_Cleaning_FINAL_FINAL.docx
  • SOP_Cleaning_FINAL_FINAL_reviewed.docx
  • SOP_Cleaning_APPROVED_USE_THIS_ONE.docx

All in the same folder. One was emailed to the team lead last month. Another is posted in the clean room. A third is what QA thinks they approved. Nobody knows which is current.

When the auditor asks for the current cleaning procedure, there's a pause. When they ask who approved it, someone searches for a signature page. When they ask who's trained on it, someone opens a different spreadsheet—one that definitely doesn't reflect reality.

This is how most companies manage their most critical documents.

One truth, one place

In Seal, every document exists in exactly one state: Draft, In Review, Approved, or Obsolete.

When someone searches for SOP-042, they see version 3.2. That's it. They cannot find 3.1 and accidentally use it. They cannot print an old version and post it. The system serves the current version and only the current version.

Version history shows every change ever made. Comparison tools highlight what changed between any two versions. Signature records capture who approved each version, when, and with what meaning. The complete story is preserved—but the current state is never ambiguous.

Document Lifecycle

Training integration that enforces itself

Here's the deeper problem with document changes: SOP version 3.2 was approved, but forty-seven people are still trained on version 3.1. Their training records say "current." The system doesn't know the SOP changed. Nobody invalidated their training. The operator uses the old procedure because nobody told them not to.

In Seal, document approval and training are structurally connected. When SOP-042 updates from version 2 to version 3:

  1. Everyone trained on version 2 has their status changed to "expired"
  2. Retraining tasks are assigned automatically based on job roles
  3. Until they complete training on version 3, they cannot execute tasks requiring that SOP
  4. The system blocks them—not policy, not emails, the actual system

The operator on the floor doesn't use the old procedure because the system won't let them proceed without current training.

Training Trigger Flow

SOP management built for SOPs

SOPs are the DNA of your operation. Every batch, every test, every decision traces back to a procedure. When your SOP system is chaos, your operation is chaos.

Seal is built specifically for SOPs:

Structured authoring - Templates ensure consistency. Required sections. Standard formatting. AI assists with drafting from your requirements.

Review workflows - Configure who reviews what. Subject matter experts, quality reviewers, final approvers. Parallel or sequential. Automatic reminders when reviews stall.

Effective date control - Approve today, effective next Monday. Training window before enforcement. Old version remains active until the new one takes effect.

Periodic review - Annual review is required by regulation. 30 days before due, the owner gets notified. 15 days overdue, the manager sees it. 30 days overdue, QA leadership is alerted. Reviews happen because ignoring them becomes harder than doing them.

Controlled printing that actually controls

When you need paper in the clean room, Seal tracks it:

  • Who printed what document
  • When they printed it
  • How many copies
  • Which version was current at print time

Printed copies include watermarks showing document ID, version, and print date. When a document is revised, holders of outstanding prints are notified that their copies should be replaced.

For critical areas, electronic display eliminates printing entirely. The screen in the clean room always shows the current version. No laminated copies. No version confusion. No $180,000 batches lost to outdated procedures.

AI-assisted document creation

Starting from a blank page is slow. Writers spend hours on formatting and boilerplate instead of content.

Seal's AI accelerates document creation:

  • Draft generation - Describe what you need, get a structured first draft following your templates
  • Reference integration - AI pulls relevant content from your existing approved documents
  • Consistency checking - Flag terminology, formatting, and cross-reference issues before review
  • Translation assistance - Maintain documents across languages with AI-assisted translation

You review, refine, and approve. The AI accelerates—you control. Full traceability of what was AI-assisted versus human-authored.

The foundation everything else needs

Document management isn't a nice-to-have. It's the foundation:

  • Your QMS runs on controlled documents
  • Your training system references SOPs
  • Your batch records point to procedures
  • Your deviations cite the document that should have been followed
  • Your CAPAs result in document changes

When document control works, everything else works better. When it fails, every other system inherits the chaos.

Start with document management. Build everything else on a solid foundation.

Capabilities

01SOP Management
Purpose-built for SOPs. Structured authoring, configurable approval workflows, effective date control, and periodic review automation. End the version chaos.
02Approval Workflows
Configure review chains that match your process. SME review, QA approval, final sign-off. Parallel or sequential. Electronic signatures with 21 CFR Part 11 compliance.
03Training Integration
Document changes automatically trigger training assignments. See who's trained on what version. Block untrained personnel from task execution. Policy becomes reality.
04Controlled Distribution
Users see only effective versions. Controlled printing with watermarks and tracking. Outstanding print notifications when documents change. Know who has what.
05AI Document Drafting
Generate first drafts from requirements and templates. AI references your existing approved documents. You review and approve—AI accelerates, you control.
06Periodic Review
Never miss a review cycle. Automatic reminders before due dates. Escalation paths for overdue reviews. Complete review history for audit.
07Full Audit Trail
Every view, edit, signature, print, and distribution logged with timestamp and user. Immutable history. Complete answer to 'who did what when.'
08Migration Support
Move from MasterControl, Veeva, Qualio, SharePoint, or paper. Bulk import with history preserved. Establish baselines. Go live in weeks, not months.
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SOP Management
SOP Management

Entities

Entity
Description
Kind
Document
The single source of truth. Only one version can be current. Users can't accidentally find the old one.
type
SOP
Standard Operating Procedures. The DNA of your operation. Every batch traces back here.
template
Policy
High-level governance documents. Less frequent changes, broader scope, cascading impact.
template
Work Instruction
Detailed step-by-step guidance. Task-specific. Often includes images and diagrams.
template
Form Template
Blank forms that become records when completed. Version-controlled. Immutable once submitted.
template
Specification
Material or product specifications. Acceptance criteria. Referenced by incoming QC and release testing.
template
Version
Complete version history with comparison. See what changed between any two versions. Every edit tracked.
type
Approval Workflow
Draft → Review → Approve → Effective. Configurable stages. Required signatures. Automatic routing and reminders.
type
Training Link
Document changes trigger training expiration. Retraining assigned automatically. Untrained users blocked from execution.
type
Controlled Print
Who printed, when, how many copies. Watermarked with version. Notification when superseded.
type
Periodic Review
Automatic reminders when review is due. Escalation for overdue. Complete review history preserved.
type
AI Drafting
Generate first drafts from requirements. Pull from existing documents. Human review and approval required.
type

FAQ

SharePoint and Google Drive are file storage. They don't enforce single-version visibility, don't connect to training systems, don't manage approval workflows with electronic signatures, and don't provide the audit trails regulators require. Seal is purpose-built for controlled documents in regulated environments—file storage with enforcement, not just organization.