Document Management
Controlled document lifecycle management for regulated organizations.
Nexgensis Document Management provides a controlled environment for creating, reviewing, approving, distributing, revising, and retiring quality documents such as SOPs, policies, work instructions, forms, and controlled records.
What Document Management delivers
A controlled path from start to closure
- 1Draft
- 2Review
- 3Approval
- 4Effective
- 5Periodic Review
- 6Revision / Retirement
Why teams move to Document Management
Reduce dependency on paper-based document processes
Improve document traceability
Ensure users access the current approved version
Reduce uncontrolled document usage
Improve audit readiness
Standardize document approval workflows
Built for regulated operations
21 CFR Part 11
Electronic records and electronic signature controls — unique user identity, secure e-signatures and computer-generated audit trails on every record.
EU GMP Annex 11
Computerised system controls including access management, change control, data integrity and periodic review of the system.
GAMP 5
Risk-based validation approach, with pre-executed IQ/OQ documentation supplied with every release.
ALCOA++
Records that are attributable, legible, contemporaneous, original and accurate — enforced at record level.
OPS IQ is designed to support these regulatory expectations. Compliance is achieved together with your own validated implementation, procedures and controls.
Connected to your enterprise systems
ERP / SAP
Master data, materials and batch context exchanged over open REST and event APIs.
MES
Shopfloor execution events and equipment context linked to quality records.
LIMS
Laboratory results and specification data connected to quality decisions.
Identity Providers
Enterprise SSO and role-based access through your existing identity provider.
Enterprise APIs
Open REST and event APIs for custom and legacy systems.