The Plant Data Field Guide.

Who it is for

For people new to the data a plant makes.

Anyone joining a pharma manufacturing site, or the team that serves one, who needs to read an operator screen, follow a batch and understand why the record has to be trustworthy, before working with the real systems.

• Practice scenarios
• Flashcards
• Glossary
• Your first week
• Final quiz
• Completion certificate
• English and Spanish

1. The plant floorThe machines on a solid-dose line, what each does and the parameters that matter to quality.
2. The control stackHow one value travels from the instrument to the screen and the record.
3. Reading an HMI screenWhat each part of an operator screen is for, on an invented coater screen.
4. Recipes and batchesRecipes, setpoints and limits, and what belongs inside a batch window.
5. Trends and comparisonReading a trend and comparing two batches by clock time or by step.
6. Alarms and audit trailsThe alarm life cycle and the questions every audit entry must answer.
7. Data integrityALCOA+ in plant terms, with the 21 CFR text beside a plain-words summary.
8. Historians and databasesTags, sampling and retrieval, with a practice SQL sandbox on invented tables.
9. Validation basicsThe V-model, traceability and how regulated software is tested before use.