PSCMS®
Pharmaceutical Stability Management Software
PSCMS (LIMS) is a turn-key Laboratory Information Management System (LIMS) tailored to pharmaceutical stability testing programs and stability management. It can be installed at your site and be up and running in less than a day. You can then access your PSCMSÂ (LIMS) deployment from anywhere with your web browser (through secure means, of course).
What is stability Study?
Stability Management (PSCMS) helps pharma industry in recording anything related to stability studies.Batches that need to be taken for stability studies under different stability conditions are first registered through a registration process. PSCMS records all the conditions under which a study needs to be conducted (temperature, relative humidity, light). System keeps track of the stability chambers available, storage locations within the chambers etc.
Batches registered can be taken for stability studies that use protocols and chambers for the study. Study creation involves the time points for pulling samples and tests to be conducted for those time points.
Samples once scheduled by the stability scheduler continue their life cycle get closed.
Stability reports such as cross tab time point wise results etc can be generated through the system. Data can be exported for further analysis. Any special report like shelf-life report, statistical reports can be integrated with the solution.
Never miss a time-point.
The Stability Study Management module creates stability study protocols. Easily Input details regarding the product, storage conditions, time-points, testing regimes, and the number of samples stored.
Set up templates and use them to easily manage your routine studies.
When the user pulls samples from storage, the samples are submitted automatically to begin the testing life-cycle. Product specifications are automatically linked with protocols.
Easily view scheduled time-points.
Alerts and e-mail notifications ensure that time-points are not missed and the user remains compliant as stability studies can last up to five years.
Easily trend data via the trending report function.