Quality management
A batch with open records doesn’t ship.
Deviations, CAPA, changes, complaints, audits, suppliers, risk and training live in one system with e-signatures, and their status decides whether a batch can be released.
What it does
Your whole quality system, tied to the batch.
Every process follows the same backbone: record number, assessment, investigation, signed approval, closure and effectiveness check.
Events and CAPA
- Critical, major and minor deviations; only minor ones can be closed directly
- Guided root cause with fishbone (6M) and 5 whys
- CAPA with plan, evidence and scheduled effectiveness check
- Improvement opportunities that turn into preventive CAPA
Changes, complaints and audits
- Change control with cross-functional assessment and signed approval
- Complaints: critical ones are investigated before replying, and the reply is signed
- Audits with checklists; every nonconformity creates a finding
- An audit can’t close with open findings
Suppliers, risk and people
- Supplier qualification and performance, with SCARs and effectiveness checks
- A supplier with open SCARs cannot be approved
- ICH Q9 risk assessment by RPN or 5×5 matrix, with signed acceptance
- Role-based training measured against the effective document version
Batch and management
- OOS/OOT investigation following the FDA guidance phases
- Release by exception: only out-of-range items, open records and analytical status
- Signed batch record PDF, stored exactly as signed
- Annual product review, KPIs and management review minutes
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
An out-of-specification result opens the OOS with the data already filled in.
DMS · BRDocument management and Digital Batch RecordDocument changes open their request in the DMS.
EQEquipmentOut-of-tolerance equipment opens a quality event with its impact.
CPVContinued process verificationStatistical process capability feeds the annual product review.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- ICH Q10
- CAPA, change control, management review and performance monitoring.
- ICH Q9
- Risk management by severity, probability and detectability.
- 21 CFR 210 · 211
- Deviations, OOS, batch disposition and release, annual review.
- 21 CFR Part 11 · Annex 11
- E-signatures and tamper-proof audit trail in every process.
- ISO 9001:2015
- Nonconformities, internal audits and continual improvement.
See a batch released by exception.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.