Resources
What you need to evaluate a GxP system, ours included.
A list of questions for any vendor, a glossary of the terms that come up in an inspection, and the documentation we share when an evaluation starts.
Guides
To understand the suite in depth.
12 regulations mapped to the nine modules, with the functionality that addresses each one.
IntegrationsPLCs, ERP, instruments, corporate directory, email, printing and AI.
Security and deploymentThe six security layers, the zone architecture and the IT requirements.
The nine modulesFrom the Digital Batch Record to continued process verification.
Evaluation checklist
Twelve questions for any GxP software vendor.
Use them with every system you’re comparing. Tick the ones a vendor demonstrated on screen, not the ones they promised. Your progress is saved in this browser only.
- Where InduBatch answers it →
- Where InduBatch answers it →
- Where InduBatch answers it: Document management and Digital Batch Record →
- Where InduBatch answers it: Laboratory →
- Where InduBatch answers it: Quality management →
- Where InduBatch answers it: Equipment →
- Where InduBatch answers it: Materials →
- Where InduBatch answers it: Quality management →
- Where InduBatch answers it: OEE and plant monitoring →
- Where InduBatch answers it →
- Where InduBatch answers it: Supplier and contract client portal →
- Where InduBatch answers it →
Documentation
What we share when an evaluation starts.
These documents exist and are sent after a first conversation, so your quality and IT teams can review them properly.
URS, IQ protocol, OQ protocol and traceability matrix.
URS, IQ, a 43-case OQ with negative controls, and traceability matrix.
URS, IQ, OQ and traceability matrix.
Application server, database, external portal and optional components.
Installation steps, database script order and final verification.
We complete your company’s questionnaire on access, data, audit and perimeter.
Glossary
The terms that come up in an inspection.
- ALCOA+See →
- Data integrity principles: attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
- APRQuality management →
- Annual product review: periodic evaluation of a product’s batches, deviations, changes and results.
- Audit trailSee →
- A chronological, tamper-proof record of who did what, when and why to an electronic record.
- Batch recordDocument management and Digital Batch Record →
- The record of how a batch was made, generated from an approved master template.
- BPMNBusiness process management (BPMS) →
- Standard notation for modeling business processes as diagrams that can also be executed.
- CAPAQuality management →
- Corrective and preventive action: removes the cause of a problem and later verifies it was effective.
- Certificate of analysisLaboratory →
- A document summarizing a batch’s analytical results against its specification.
- CpkContinued process verification →
- Process capability index: how centered and how much margin a parameter has within its limits.
- CSVComputer system validation →
- Computer system validation: demonstrating that a system does what it should for its intended use.
- FEFOMaterials →
- First expired, first out: the rule for choosing which material lot to use.
- Golden batchContinued process verification →
- A reference profile built from batches that went well, against which others are compared.
- IQ · OQ · PQEquipment →
- Installation, operational and performance qualification of a system or piece of equipment.
- OEEOEE and plant monitoring →
- Overall equipment effectiveness: availability times performance times quality.
- OOSLaboratory →
- Out-of-specification result: requires a documented investigation.
- OOTQuality management →
- Out-of-trend result: within specification, but different from expected behavior.
- Part 11See →
- 21 CFR Part 11: FDA requirements for electronic records and signatures.
- SCARSupplier and contract client portal →
- Supplier corrective action request.
- URSComputer system validation →
- User requirements specification: what the system must do, and what it is validated against.
Want to see all twelve answers on screen?
In the demo we walk through the evaluation checklist with the suite open.