Oracle Quality is the most generic module that Oracle ever offered with a flexibility to configure anyway to meet your business requirements.

Collection Elements: Collection elements are the attributes/variable (fields) that captures the information. Eg if you want to capture temperature, height during your inspection then you define them a collection elements. Oracle offers seeded collection elements that supports all major transactions, but you can define unlimited collection elements as you need them.

Collection Plans: Collection Plans are set of collection elements. If you want to capture different set of elements at receiving, shipping & manufacturing, then you define separate collections plans for each of your business process.

Specifications: Specifications are characteristics of items you produce or receive must conform.

Data collections: Once you setup collection elements, plans, specifications you can do data collection in any of your business process. Collected data can be analyzed against specifications and necessary disposition actions can be made.

21 CFR Part-11: Food and Drug Administration (FDA) issued Code of Federal Regulations (CFR) that computer softwares that are used for capturing data eletronically. Part-11 of CFR dictates the need to maintain electronic records (audit trail of every changes) and electronic signatures (online sinatures when certain changes happened). Oracle supports electronic records and electronic signatures (ERES) to meet Part-11 requirements.