Laboratory Information Management System (LIMS) is evidently a necessity for laboratories to manage their daily operations with greater efficiency. Pharma companies strive to ensure compliance, increase productivity, and align thoroughly with standard processesDigitalization of processes with a robust LIMS system adds value to the lab in various ways.  

1.Increase Operational Efficiency 

LIMS software improves lab productivity through automation of workflow. Digitalization simplifies and accelerateslab processes. These automated processes facilitate in lesser time spent by scientists in doing repeated lab data entry in notebooks. Once fed in into the system, the LIMS can automatically fetch data when needed. It also reduces transcriptional and other human errors to ensure efficiency. In some Pharma companies, with Robotic Process Automation (RPA), many repetitive works with machines like HPLCs, GLCs that need human presence are remotely managed.  

Instrument integration is another important feature of LIMS software that reduces the manual effort of reading and recording instrument measurements. With integrations with several instruments, this step expedites the processes further and reduces the chances for human errors. Automation of lab with LIMS will increase operational efficiency, reduce effort, enable tracking of details, and save time that can be used for resolving more important business problems.  

2. Ensure Regulatory Compliance and Data Integrity  

With E-Audits becoming the norm of the day, manual maintenance of lab data and meeting regulatory requirements meticulously become tedious work. A robust Laboratory Information Management System (LIMS) ensures regulatory compliance by meeting all the relevant compliance guidelines of FDA, MHRA, and other renowned regulatory bodies. LIMS software that is 21 CFR Part 11 compliant will ensure accuracy and traceability in lab processes with audit trailsThe integration of LIMS with other systems will remove transcriptional and other errors which are inevitable with human presence. It automatically ensures data integrity. A robust LIMS can alleviate the regulatory concerns and make Pharma companies audit-ready for any planned or surprise internal, external, vendor, and regulatory audits.  

3. Efficient Sample and Inventory 

Sample management is the biggest concern of a lab where every step of the sample life-cycle is manually recorded. It involves lot of time on part of scientists, QA, and other members to check and record the sample at every stage of analysis. With digitalization of the sample analysis workflow, they will be spared from the ordeals of day-to-day repetitive data recording works. The LIMS system automatically fetches the results of each analysis performed and ensures recording of every minute detail for audit purpose. The user need not remember any details for future reference. Complete details of the analysis performed will be available in records and audit trail.  

Managing inventory is simple with an efficient Laboratory Management System (LMS). The details of inventory expiry, exhausted stock list, etc.  are available at the fingertips. Alerts to avoid delay or stagnancy in process ensure timely action.  

4. Achieve RFT – Do It Right the First Time 

Errors and discrepancies can crop up in manual system when appropriate checks are not performed during execution. Do it right the first time concept ensures that every step is performed after series of checks to ensure success the first timeThe configurable and predetermined workflow in a LIMS software will not allow the user to deviate from the track. There is complete control over the process flow. Further, an efficient LIMS system makes sure that RFT is attained every time a user performs a function as per the workflow. 

5. Accelerate Review Process with Review by Exception 

In manual process, the documents go through many levels of reviews. Sometimes, the reviewer reviews whole set of documents couple of times to check for a specific issue. It involves lot of time and effort of the reviewer. With automation of the review process and usage of review by exception (RBE) concept in LIMS, the process is accelerated, and review time is decreased. The reviewer checks only parts of the document which is sent for review. Further, the LIMS software analyses and finds the average review time to make future predictions based on the past reviews. It, in turn, helps the reviewer to accommodate a greater number of reviews, thus accelerating the review process. 

6. Improve TAT with pendency reports 

Pendency has direct impact on the Turn Around Time (TAT) and indirectly on the overall productivity. Maintaining manual pendency reports and providing required alerts in a paper-based process is not easy. It requires lot of time and constant persuasion to find out the status of a particular assigned task. In LIMS, a user gets complete details of pending tasks on the system dashboard itself. The reviewer, approver and all other members of higher management can use the pendency reports to check and improve TAT, increase efficiency, and productivity.  

7. Reduce Downtime Issues with Periodical Alerts 

A user should ensure that all instruments and equipment are calibrated as per schedule. An eye on preventive maintenance also needs to be kept which needs to run on a set schedule. If an analyst uses non-calibrated instrument for testing, it will lead to 483s from audits. Using a robust LIMS will help avoid such mishaps.  It reduces the instrument or equipment downtime issues by providing periodical alerts for calibration and preventive maintenance. It doesn’t allow the user to use a non-calibrated instrument for analysis. 

8. Support Predictive Analysis 

Senior management takes effective business decisions related to process based on the trends and reports of Lab process. In manual system, it takes huge amount of time and effort to prepare such reports. Further, the complications involved in the preparation of the reports do not provide a conducive atmosphere for the QA to work on them. On the other hand, LIMS provides complete reports with analysis time, sample details, test results, and other relevant details on dashboards very quicklyIt also facilitates predictive analysis for future months regarding the usage of sample, time taken, and all other important aspects based on the trends and reports of past months. It helps in ironing out all the issues beforehand and to ensure better productivity.  

To know more on how CaliberLIMS can add value to your lab, schedule a Demo or contact us for further details.