CaliberLIMS lays a strong foundation for demonstrable adherence to Good Manufacturing Practices (GMP) and Good Lab Practices (GLP) guidelines. Its innovative design helps ensure 100% compliance addressing all the pharmaceutical lab complexities. It facilitates totally paperless automation of the entire lab information workflow from start to finish. It helps manage Lab Resources, and can also be integrated with ERP, seamlessly and cost effectively, enabling quick ROI.
A case study of a 100% Paperless Laboratory implemented by Caliber at a leading healthcare company.While working with sensitive, critical information, paper may not be the wisest instrument to use at your laboratory. It exposes your laboratory not only to data security threats, but also to a staggering decrease in efficiency.
Paper is the real monster in your laboratory.This case study brings to light the incredible benefits of taking the leap to go completely paperless.
CaliberLIMS and its implementation practices are designed to meet the guidelines of cGMP, GLP, GDP, GAMP and regulatory compliance as per 21 CFR Part 11, EU GMP Annexure 11, ICH Q7 and FDA pharmaceutical industry quality control norms.
CaliberLIMS brings in a visible change in the perception of the lab team on quality systems. Adhering to quality systems is no longer a burden since it happens on its own.
Trend analysis on several factors like test results of a particular product, performance of any analyst, turnaround time for sample testing, cost analysis for the testing, when done manually, could take hours and days. With CaliberLIMS it is just a click away and takes less than 10 seconds.
With PAT guidelines gathering more importance, sample quality trend has become a necessity and Out of Trend results are to be investigated for the root cause. CaliberLIMS generates test trend on the fly in comparison to the batch history with built in configurable charting tool.
Caliber LIMS comes with a built-in ELN (Electronic Laboratory Notebook), which helps you keep track of all the activities in your laboratory.
CaliberLIMS’ modular structure significantly simplifies the laboratory workflow tasks from Sample Login to Certification with traceable authenticity.
At the core is the sample workflow and has 13 modules in plug-and-play mode.
Integration with Laboratory instruments with integrated user & instrument logbooks, seamless bi-directional integration with CDS, File and Port based instruments with integrated document management with industry-first capability of sample dossier preparation.
with the reduction in the time, burden and tension on the analyst, the analyst’s efficiency will be greatly increased. With CaliberLIMS, the analyst’s efficiency, or the lack of it, actions and output can be monitored more closely and automatically. Supervision will be more effective. This will result in enormous increase in productivity and profitability of the laboratory.
Configurable alerts help in auto notification of current and upcoming tasks, improves planning and execution without last minute surprises.
Elimination or drastic reduction in human errors in record keeping, calculations and transcriptions. No human inertia, no fatigue, no tendency to procrastinate.
Change Tracking, Audit Trails, 21 CFR Part 11 compliance. CaliberLIMS maintains all the data authentic, secure and tamperproof.
Since CaliberLIMS enables authentic and secure electronic records, the lab work would be largely paperless. This results in decreased needs and probable hazards of storage, and also prevents the possibility of losing paper documents and records.CaliberLIMS has no client installation, hence requires least maintenance and the User is free to use any system in the Network.
Budgeting and staying within the budget is a tight ropewalk. Unless costs are kept track of, it is humanly impossible to remain within the budget. In CaliberLIMS, a monthly report or, for a specified period, is again a just click away and takes less than 10 seconds.