Analysts note every detail on paper as per regulatory norms. But paper notebooks bring the challenge of handling back dated entries, typographical errors, long term legibility issues of handwritten notes. Resolve these issues with lab notebook automation.

Electronic Laboratory Notebook (ELN) effectively replaces paper lab notebook in the QC operations and ensures to meet ALCOA+ guidelines. With CaliberLIMS built-in ELN, turn complex calculations simple. ELN/ Electronic Worksheet (EWS) captures details and limits access only to  calibrated instruments and to inventory within validity period. 

Manual inventory management are sometimes error prone. Incorrect projection of inventory demand and supply, challenge in real-time updating of inventory details, misplacement of inventory are some major issues.  

Using a comprehensive LIMS system such as CaliberLIMS, analyst can track reconciliation and maintain inventory levels with ease. The crucial inventory modules are tightly bound with sample management. The workflows are detailed and defined for each module as per industry procedures. CaliberLIMS assists  analyst to monitor the lab inventory and calculate the usage of each sample as per GAMP.  

Data integrity and compliance are inter-related aspects influencing audit-readiness. On one hand, an effective LIMS system can automate individual phases of the lab process and collate data securely like a Lab Execution System (LES). On the other, it ensures adherence to 21CFR Part 11 and cGMP needs for audit process by focusing on Chain of Custody (COC) of each sample with date and time stamps. 

CaliberLIMS assists in being audit-ready. Data can be captured through instrument integration, usage of built-in ELN, configuration of Masters. It also facilitates instrument calibration and captures analyst qualification details. In this way, all the relevant data is saved.