LIMS for Government Regulatory Labs

LIMS for Government Regulatory Labs

GOVERNMENT REGULATORY LABS

Government regulatory labs like the official medicines control labs perform control testing of various biological substances like vaccine, blood products and immunological substances. These labs perform testing on almost every
batch to be released in European market. The process of product batch release involves the analysis of finished product batch along with raw materials and ingredients used in the process of manufacturing and preparation of such products. These batches are released or put on hold against a specification that is acceptable in the country or region of intended sale of the batch. The control testing lab releases the final certificate as Pass/Fail based on outcome of testing conducted.

CONTACTS AND PRODUCT (MANUFACTURERS, MARKET AUTHORIZATION HOLDERS)

Different contacts such as manufacturers, MA holders, clients and suppliers can be managed and in turn can be associated with the samples analysed. Products and Components analysed can be managed and creation of product records can be controlled through review and approval before releasing to the end users.

TESTS & SPECIFICATIONS MANAGEMENT (STUDY PLAN)

Test masters with relevant attributes and switches can be maintained based on test category and sections that will handle tests. Tests can have one or multiple parameters. Parameters can be numeric, character, pre-defined values, attachments etc. Tests can be linked to instruments, rounding rules, analysis techniques which is in turn linked to personnel and their training records.

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