Specification Management

Specification Management

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

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