LIMS in the pharmaceutical industry

CaliberLIMS for Stability Studies Challenges Stability studies is a key operation in the pharmaceutical industry as it helps to determine the expiry date of a drug and any deviation in this process would directly effect the human health due to which regulatory bodies focus is more in this area so as to ensure the safety of the human health.

This brings the need for XXXX to evolve from using the legacy paper based process to an automated stability study applications which would help to overcome the bottle necks and ensure the documents submitted to the regulatory bodies are more legitimate. .

An average QC stability Analyst at XXXX Spends around 5 days of efforts in a month in formulating the summary Reports or the data required to submit the regulatory authority’s with the traditional MIS tool’s but still as we know the famous phrase “To ERR is Human” To Tackle the mentioned Bottlenecks, to some extent analyst had relied on tools such as MS-Excel but as the size of the data increased it became cumbersome and it was also not justifiable to the regulatory bodies as the scope of data manipulation is more and there is no specific controls or alarming systems which could prevent the occurrence of the issues or increase the efficiency.

Let’s take a look on Few common problems observed on Stability Studies     

Lack of reliable stability data to support expiration date.

Missing analysis at Stipulated Timelines.

Inadequate evaluation of OOS results.

Incorrect Labelling of Stability Samples that led to lab errors.

Improper planning on pulling the sample due to lack of availability of cumulative data

Solution There is a high need of a robust system which could meet the regulatory needs and also helps to increase the productivity of xXXXX so as to achieve the business targets with a superior quality.

Laboratory Information Management System(LIMS) is once such application which helped XXXXX to achieve all the needs to manage the stability Studies with a complaint proofed automation .

CaliberLIMS tops among the several LIMS suppliers globally with its unique solution and adhering to the ICH guidelines for complete stability operations. 

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Summary report being one of the conclusive reports of stability studies is generated through a single Click with enhancive details such as results at each time point in a specific condition and configurable as per market as XXXX does business in multiple geography’s its must and sure for them to adhere to the local regulatory requirements and CaliberLIMS helped them to achieve in much efficient way and avoided redundancy and manual errors.

As planning being a key for successful execution ,CaliberLIMS generates yearly and month wise calendars which helped the lab supervisors to plan their resources and work accordingly and to avoid the discrepancy’s ,application alerts the user’s to pull the sample on the intended day so that analysis would be done as per the defined protocol and achieve zero deviations.

Determining the trend or comparing the current results with the trend seems to be an efficient way of determining the quality in Sample ,CaliberLIMS application helps the user’s to set the trend limits either based on the intial results or from the previous pulls results so that any OOT observed is alerted to the person who has submitted the results and as well as to the reviewer so that further OOT investigation can be initiated through the application Tracking the quantities and determining the location of the samples based on the chambers in which they are placed is a tiring job through the traditional processes which xXXX was face but through the caliberLIMS application maintaining the reconciliation of the quantities became a cakewalk as reports such as reconciliation report or the sample location reports are generated through the system automatically and is also available in printable format.

The problems such as the breakdown of chamber’s and transferring the samples to the standby chamber and tracking the details which are real time stumbling blocks is been handled through an inbuilt feature which are specially designed to handle these type of problems.