The regulations require an annual product quality review (PQR) of all products that are manufactured at a manufacturing facility.
OasisLIMS-APQR module helps you meet objective of verifying the consistency of the existing manufacturing process,
the appropriateness of current specifications for raw materials and finished products and the ability of your stability data
to highlight any trends, and to identify product and process improvements.
The analytical data is captured from OasisLIMS for all the stages the product goes through including in-process and
finished stage with batch tracking. Annual product quality review for all the batches of a finished product manufactured
during the year / period:
Decreases the risk of OOS results / minimizes the risk of rework-reprocessing/ decreases downtime
Increases productivity / decreases the risk of product recalls / meets all regulatory commitments / requirements
Improves communication between production, engineering, quality and regulatory functions; recording of process / raw data
on various stages
Graphical representation / histograms of processing parameters / generation of trend on yield data
Generation of reports from OasisLIMS on various quality attributes of finished product / storage,
maintenance of stability studies records / data trending of selected tests, graphical representation of analytical
data and summaries, provision to maintain complaints data, product recall data / deviations, Failures and OOS results
handling / change controls, etc.
