GMP without the paper chase.
Deviations, CAPA, change control and training kept complete and traceable, with a named person signing every record.
- Mapped
- 6 requirements
- Agents
- 5
- Your copy
- stays the reference
Every requirement, with its evidence, before the audit.
SmartHow maps your documents and records to each requirement and shows the one gap that is left, with its owner.
- DeviationsRecord and investigate every departure
- CAPACorrect and prevent recurrence
- Change controlAssess every change before it is made
- DocumentationKeep procedures approved and current
- TrainingQualify people for their tasks
- Data integrityKeep records attributable and complete
What it asks for, and what does itself.
In our words, by clause. Your licensed copy of the standard stays the reference.
| Topic | What it asks for | What SmartHow does by itself | Agent |
|---|---|---|---|
| Deviations | Record and investigate every departure | Drafts the deviation report from the first account | Investigations |
| CAPA | Correct and prevent recurrence | Follows each action and checks its effectiveness | CAPA follow-up |
| Change control | Assess every change before it is made | Finds every document, batch and person a change affects | Procedures |
| Documentation | Keep procedures approved and current | Drafts revisions when documents conflict or age | Procedures |
| Training | Qualify people for their tasks | Trains the people each change affects | Training |
| Data integrity | Keep records attributable and complete | Records who drafted, changed and approved every output | Audit readiness |
GMP regulations are public: ANVISA RDC 658/2022, FDA 21 CFR 210 and 211, and EudraLex Volume 4. GMP use requires a validated system; validation is planned with each customer's quality unit.
What system owners ask first.
Do we need to give you the standard?
No. You keep your licensed copy. SmartHow maps your documents and records to each clause by number.
Does SmartHow certify us?
No. Certification is granted by an accredited certification body. SmartHow keeps you ready for it.
Is it validated for GxP use?
GMP use requires a validated system. Validation is planned with each customer's quality unit; ask us for the current status.
Other frameworks in the same system.
Watch your management system run itself.
In 30 minutes we run SmartHow on a real case from your industry: an incident report writes itself, a procedure fixes itself, a lesson reaches every plant. You only approve.
- A real example from your industry, not a slideshow
- 30 minutes with an industrial engineer
- Leave knowing where it saves your plants the most hours