Paper-based SOP management
Printed SOPs, signature books and controlled copies consume time and create inspection exposure.
Document Management System (DMS)
Digitize and control your critical business documents with a centralized Document Management System that automates document creation, review, approval, distribution, revision and archival while ensuring complete compliance, traceability and data integrity.
- 21 CFR Part 11
- EU GMP Annex 11
- ISO 9001 & 13485
- ALCOA+
OPS IQ DMS
Document Control Centre
1,284
Effective documents
31
Pending approvals
48
Reviews due 30d
SOP-QA-014 · lifecycle
v4 · rev in progressDraft
Review
Approval
Effective
SOP-QA-014Quality reviewPending
SOP-PR-208Approval — QA HeadSigned
WI-LAB-036Periodic reviewDue 12d
Paper-based documents versus Nexgensis digital DMS
The same controlled documentation, governed by automation and evidence instead of binders, photocopies and follow-ups.
Traditional paper-based documents
- Documents spread across drives and cabinets
- Approval chased by email and signature books
- Multiple uncontrolled copies in circulation
- Wet-ink signatures on printed pages
- Manual searching through folders
- Uncontrolled photocopies and email attachments
- Trails reconstructed before an inspection
- Compliance depends on discipline
Nexgensis digital DMS
- Single centralised document repository
- Automated, role-based approval workflows
- Strict version control with one effective copy
- Part 11 compliant electronic signatures
- Instant retrieval by metadata and full text
- Controlled distribution with read acknowledgement
- Complete, time-stamped audit trails
- Regulatory compliance enforced by the system
Document control breaks down long before the audit
Uncontrolled versions, manual approvals and missing traceability are the most common findings in regulated documentation.
Uncontrolled document versions
Superseded copies stay in circulation and staff work to documents that are no longer effective.
Manual approval processes
Reviews stall while documents move between desks, departments and sites for signature.
Missing document traceability
Who changed what, when and why cannot be answered without reconstructing the history by hand.
Difficult audit preparation
Every inspection triggers weeks of collating documents, approvals and training evidence.
Compliance risk
Paper cannot evidence the data integrity and access controls that regulators now expect.
From creation to controlled archival
Every document follows one secure, controlled lifecycle — each stage attributable, time-stamped and reviewable years later.
Document Creation
Authored from a controlled template with automatic numbering.
Review
Routed to technical and quality reviewers with tracked comments.
Approval
Role-based approval against the configured document workflow.
Electronic Signature
Meaning-bound signature with identity, timestamp and reason.
Effective Release
Released on the effective date with controlled distribution.
Periodic Review
Scheduled review with automatic reminders before the due date.
Revision
Change-controlled revision creating a new, traceable version.
Archive
Superseded documents made obsolete and retained with full history.
Everything document control needs, in one system
Configurable workflows with role-based electronic approval
Route each document type through the stages your quality system requires — sequential or parallel, with escalation and Part 11 signatures at every decision point.
01
Draft
Author prepares the document from a controlled template.
02
Technical Review
Subject matter experts verify technical accuracy.
03
Quality Review
QA verifies compliance, format and cross-references.
04
Approval
Authorised approver signs electronically.
05
Released
Document released and locked against further edits.
06
Effective
Becomes effective on the scheduled date after distribution.
07
Periodic Review
Reviewed on schedule to confirm continued suitability.
08
Revision
Change-controlled revision starts the next version.
09
Obsolete / Archive
Superseded version withdrawn and archived with history.
Built for regulated industries
Documentation controls are enforced by the system, so inspection evidence is a report — not a project.
FDA 21 CFR Part 11
Electronic records and signatures with secure, computer-generated audit trails.
EU GMP Annex 11
Computerised system controls, access management and periodic review evidence.
ALCOA+
Attributable, legible, contemporaneous, original and accurate document records.
GAMP 5
Risk-based validation with documented lifecycle deliverables for each release.
ISO 9001
Documented information control aligned with quality management requirements.
ISO 13485
Medical device document and record control, including retention obligations.
WHO GMP
Documentation and record-keeping expectations for regulated manufacturing.
Electronic Signatures
Meaning-bound signatures on review, approval and effective release.
Audit Trails
Every create, edit, approval and distribution event permanently recorded.
Data Integrity
System-enforced controls so integrity does not depend on individual discipline.
Controlled documents, controlled access
Who can see, edit, approve and distribute each document is governed centrally — and every action leaves a permanent record.
Role-Based Permissions
Least-privilege access by role, site, department and document type.
User Authentication
SSO and Active Directory authentication with password policy enforcement.
Electronic Signatures
Re-authentication at the point of signature, bound to a stated meaning.
Audit Logs
Complete logs of access, changes, approvals and distribution events.
Document Encryption
Encryption in transit and at rest across the entire repository.
Secure Cloud Storage
Tenant-isolated, validated cloud storage with monitored access.
Backup & Recovery
Validated backup schedules with tested restore procedures.
Version History
Every revision retained, comparable and permanently attributable.
One document core, connected everywhere
Controlled documents feed the quality, laboratory and enterprise systems that depend on them — without duplicate copies.
Quality & laboratory
eQMSLIMSELNeBMR
Enterprise systems
SAPERP SystemsMicrosoft Active Directory
OPS IQ DMS
Document core
Platform services
REST APIsEmailCloud Storage
Bi-directional
Effective SOPs and specifications flow out to eQMS, LIMS, ELN and eBMR; change requests and training events flow back — with the audit trail preserved.
Document health, visible in real time
Operational dashboards for document controllers, KPIs for quality managers and compliance views for corporate QA.
Documents by Status
Draft, in review, approved, effective and obsolete at a glance.
Pending Approvals
Open approval tasks by owner, document type and ageing.
Expiring Documents
Documents approaching expiry or effective-date changes.
Overdue Reviews
Periodic reviews past due, with escalation to document owners.
Document Revisions
Revision volume and cycle time by department and document type.
Department-wise Documents
Document population and workload split across departments.
User Activity
Access, read acknowledgement and approval activity by user.
Compliance Status
Inspection-readiness score across controlled documentation.
Measurable documentation outcomes
0%
Faster document approval
0%
Reduction in paper usage
0%
Version control coverage
0%
Faster audit readiness
Centralised documentation
One governed source of truth across every site and department.
Improved compliance
Controls enforced by the system rather than by individual discipline.
Improved productivity
Less time spent searching, printing, chasing and reconciling documents.
Reduced manual errors
Templates, numbering and workflows remove avoidable documentation errors.
Trusted across regulated industries
Pharmaceuticals
Biotechnology
Medical Devices
Food & Beverage
Chemicals
Life Sciences
Manufacturing
Healthcare
Why quality teams choose OPS IQ DMS
Unified OPS IQ platform
DMS shares one data model with eQMS, LIMS, ELN and eBMR.
Compliance by design
Part 11, Annex 11 and ALCOA+ controls enforced at record level.
Intelligent workflow automation
Configurable routing, escalation and effective-date automation.
Cloud or on-premise
Deploy in our validated cloud or inside your own data centre.
Enterprise security
SSO, encryption, least-privilege roles and continuous access monitoring.
Multi-site support
Global and local documents governed within one harmonised hierarchy.
Seamless integration
Native quality-suite links plus SAP, ERP, Active Directory and REST APIs.
Scalable architecture
From a single plant to an enterprise document network.
DMS questions, answered
A DMS is a controlled system for creating, reviewing, approving, distributing, revising and archiving business-critical documents such as SOPs, policies, specifications and work instructions — with every action captured in an audit trail.
Transform document control with intelligent digital management
Eliminate paper-based documentation and automate the complete document lifecycle with a secure, compliant and enterprise-ready Document Management System.
- 45-minute working session on your own document workflow
- Version control, distribution and signature walkthrough
- Migration and validation evidence review