Specification management helps an organisation maintain specifications of various products based on their categories with a multi-layer specification for each product.
- Products can have several Groups.
- Ex. Different dosage forms like capsules, syrups, etc. are a Group.
- The Sub-group is segregated based on potency or active ingredient composition
- The profile is a type of specification the product has to pass through
- Ex.Pharmacopeia in Pharma
- Under a profile, specific versions are maintained & released with one active at any time point
- Specifications have tests/ parameters to be analysed & recorded with numeric tests (limits) &non-numeric tests (pass or fail) Band-A-Out-Of-trend (OOT) Band-B-Out-Of-Specification(OOS)
- Documents for each of the above layers can be uploaded