QualiDocument control
Create, review, approve, train, issue, revise, archive, and retain controlled content with complete version history.
Explore DMS → Built for life sciences quality
Quality work, finally in control.
QualiGxP is a pharmaceutical document and quality management platform. Bring controlled documents, quality events, approvals, and optional AI assistance into one workspace designed for GxP operations.
✓ Controlled workflows
✓ Electronic signatures
✓ Complete traceability
workspace.qualigxp
Quality Admin
Quality overview
Good morning, Quality Team
128Controlled
14In review
96%On time
8Open CAPAs
Approval activity
AI assistant
Three documents are ready for metadata review.
✓
Approval completed
Audit trail captured
Designed around regulated work
US FDA 21 CFR Part 11
EU GMP Annex 11
ALCOA+
WHO GMP
21 CFR 210 / 211
One connected platform
Every quality process.
One source of truth.
Start with document control, then license quality management and AI when the operation needs them. DMS is the required core. QMS and AI depend on it.
Quality management
Connect change control, deviations, investigations, CAPA, and computer system validation to the same controlled records.
Explore QMS →Responsible AI
Accelerate drafting and structured work with module-aware assistance. People still review, approve, and sign.
Explore AI →A clear chain of control
01
Draft created
Owner assigned
02
Review completed
Evidence recorded
03
Approval signed
Identity verified
04
Version issued
History preserved
Built for quality teams
Less chasing.
More confidence.
QualiGxP makes ownership, status, evidence, and history visible at every step — so teams can focus on quality instead of administration.
Clear accountability
Know who owns the next action and what is holding work back.
Connected evidence
Keep decisions, signatures, attachments, and changes with the record.
Purpose-built workflows
Apply structured quality processes without forcing teams into spreadsheets.
Modular by design
Use DMS as the core and add QMS or AI capabilities when needed.
Who it is for
Made for pharmaceutical operations.
Document control
SOP authors, checkers, approvers, and document controllers managing templates, masters, issuance, and retention.
Quality assurance
QA reviewers handling deviations, CAPA, change control, effectiveness checks, and independent disposition.
Manufacturing GMP
Production teams completing issued BMR, BPR, log, form, and checklist execution records with independent verification.
Validation
CSV teams tracing requirements, tests, evidence, residual risk, and signed QA release of computerized systems.
Talk to QualiGxP
Give every document and decision a trustworthy home.
Private files, permission-aware actions, attributable approvals, immutable history, and licensed modules are designed into the platform. Request information for your site — no public demo is required.
Request information