Pharmaceutical LIS

Pharmaceutical companies need to collect data reliably and efficiently. While doing so, they must also protect their data systems with a protected and completely audible structure. A flourishing pharmaceutical LIS will help reduce costs, develop the quality of data collected as well as save time to market the products effectively.

The LIS software controls all the aspects of the workflow, reporting, testing and regulatory necessities required in a pharmaceutical LIS. Dissolution testing and stability determination can be managed through the configuration of LIS. Some advanced data tracking, such as for chemical properties, excipients, and formulations of compounds are readily available because the flexibility of system in an object attribute.

Diagnostic Tools in LIS

Pharmaceutical companies can save time and money by categorizing issues with new targets by using the powerful diagnostic tools. The system also includes user driven data authentication and curve-fitting competence. These features help laboratories evaluate their data to assess whether or not a target is worth chasing.

By weeding out the “bad” candidates early in the process, laboratories can save the money which would have been used on additional research and testing. The companies can then use that money to find new targets.

Quality Management in LIS

LIS software manages lots, cases and batches efficiently. The system includes the practicality to maintain results validation, approval and certification, thus ensuring the highest quality of products. Different batches and lots can be accepted or rejected, depending upon the customers’ criteria. Batches can easily be checked against various data specifications to make sure that the standards are met.

Case Management for Forensic Labs in LIS

Some software developing companies have also provided case management functionality for forensic labs’ batch, lot and e-document management. The laboratory analysts link documents and test results etc. with a piece of evidence, suspect, victim or any other object required by the laboratory. The data remains traceable for the company.

LIS software can also receive user or customer specifications from various other systems applied in the laboratory. It can implement compliance with the criteria and notify the analyst collecting data, or compose a batch of the particular specifications. This will help standardize data and processes across the organization.

LIS Myth

Many companies believe that they will need to select a LIS (Laboratory Information System) from a wide variety of generic systems and spend a lot of their precious time to understand, evaluate and address its critical functions and then authenticate the system.

For pharmaceutical companies, the above mentioned approach has been very difficult. The critical data and procedures of a pharmaceutical company cannot be overstated under the GxP environments or the FDA (Food and Drug Administration). The workings of LIS must be recorded, tested and validated because every step in the drug invention and development phase should be kept in record.

Custom Confirmation scripts of LIS

The custom codes require “custom confirmation scripts” which should be produced and authenticated in their own way. With every upgrade and latest release of a general LIS, the scripts should be retested and re-authenticated to ensure successful upgrading. Holding off the implementation and validation causes difficulty with the general LIS.

Published: 19 Sep 2024