DQMS
Digital quality management, without the legacy weight.
Documents, events, training, audits, yield — one closed loop. Built for Part 11 and Annex 11.
Site · Bengaluru fill-finish
Quality operations
Open CAPAs
7
Deviations / 30d
12
Training overdue
4
Avg. batch yield
97.4%
Yield by batch · last 12
Live events
- DEV-2418Fill weight OOT · Line 2
- CAPA-0904Effectiveness check due
- CHG-112Filter spec revision
Closed loop
Quality is a chain of records, not a collection of forms.
01
Event to effectiveness
A shop-floor deviation becomes an investigation, a CAPA, a document revision, and a training assignment — with the links preserved for the inspector.
02
Change to the floor
Impact assessment covers documents, equipment, validation, suppliers, and roles. Nothing is marked complete until the current version is effective and people are trained.
03
Yield to quality
Batch yield, rejects, and OOS sit next to open quality events so manufacturing and QA look at the same picture in the daily meeting.
Modules
Everything a modern eQMS is expected to hold.
Start with documents, deviations, and training. Add the rest as the site matures. The data model is shared, so you are not integrating your own QMS to itself.
Document control
Lifecycle management for SOPs, specifications, forms, and work instructions with versioning, effective dating, obsolescence, and role-based access to the current approved copy.
CAPA & deviations
Capture events, run structured investigations, link root cause to action, verify effectiveness, and keep the full history inspection-ready.
Change control
Assess impact across documents, equipment, suppliers, validation, and training before a change is approved — then close the loop automatically.
Training & competency
Curricula by role, automatic retraining on document revision, quizzes, due-date escalation, and a complete training file for every person.
Audit management
Plan internal, supplier, and regulatory audits, run checklists, log findings, and open CAPAs without leaving the record.
Supplier quality
Qualify, score, and monitor suppliers. Keep quality agreements, questionnaires, and incoming inspection results in one file.
Risk management
ICH Q9 / ISO 14971 aligned risk registers connected to changes, CAPAs, and design or process FMEAs.
Yield & batch quality
Track theoretical versus actual yield, OOS/OOT, rejects, and process capability so quality and manufacturing share one picture of the batch.
Data integrity
Built so the record can be trusted.
Electronic signatures, attributable audit trails, role-based access, and operational checks are not add-ons. They are how DQMS writes a record.
- Unique identity and meaning of signature
- Time-stamped, attributable audit trail
- Current-version enforcement for controlled documents
- Retention and export for inspection packages
Typical first 90 days
- 1
Discover
Map current SOPs, events, and training matrices.
- 2
Configure
GxP templates, roles, and site structure.
- 3
Validate
Risk-based CSA with our IQ/OQ package.
- 4
Go live
Documents and deviations first, then the rest of the loop.
45 minutes
Walk through DQMS on a real process.
Forty-five minutes. Bring an SOP, a deviation, or a validation gap.
Book a demo