Sample Management involves all the activities during the lifecycle of a sample in the lab. Right from sample login to generation of certification of analysis (COA), all information must be diligently managed. If data management at each stage of the process is done manually, the process itself would take away chunks of time from the QC’s day for analysis/ review/approval and QA for review/ approval. In turn, this would delay the production time of the batch and its release. In addition to the delay in time, there could be typographical and manual errors when this process is person-dependent.
To overcome these issues, labs must automate and digitalize their processes with digital tools available. A robust LIMS system that has built-in Sample Manager, EWS, ELN, LDMS, etc. can solve all these issues and help in reducing the process time effectively.
The sample management process includes various stages such as Sample login, E-Sampling, Sample Acceptance, Sample & Test Allotment, Test Result Submission, Review and Approvals, COA Printing, and raw data (executed worksheet, inventory logs, trend reports, and dossiers). Digitalizing these stages with a good LIMS system will help complete the sample management process quickly and effectively.
Sample Login – With a robust LIMS system like CaliberLIMS, sample login can be done quickly. The system automatically generates an Analytical Reference (AR) number to maintain unique identity. This AR No. is the sole identity of the sample throughout its lifecycle.
E- Sampling –E-sampling is equipped with E-sampling rules, E-sampling tests, and automated labelling which will reduce predominant work time that is invested by the person who is performing sampling by calculating sampling quantity versus total quantity through sampling rules. Driven by system, Auto label generation, sampling test, calculation of number of samples to be sampled will be automatically calculated by the system through sample rules
Sample Acceptance – It will enable the QC to receive the sample from warehouse or the front desk for testing.
Sample & Test Allotment – The user can simply allot the sample to only qualified analyst. The sample distribution process can be further simplified in a way where the sample could be distributed between team leaders and analysts considering the occupancy/ workload of each analyst through proper analytical
Test Result Submission – Test results can be fetched directly from the instruments seamlessly through port, file, and CDS based interface. This shall avoid all possible manual errors and facilitate regulatory compliance like ALCOA. This shall further enable seamless resources interface by enabling “do it right the first time” concept. Auto-calculation feature enables user to avoid calculation errors and reduce review burden.
Review and Approval – System promotes “Review by exception” concept by differentiating the reported results in three different segments.
1) Standard template – represented in black colour,
2) Reported Analytical details – That include test results, inventory resources, and instrument/ equipment details, will be represented in blue colour
3) Exceptions – will be highlighted in red for easy recheck or review by QA/ QC.
All reference documents will be available during review and approval. OOT/ OOS details shall be indicated during review process.
COA generation and printing – Auto generated COA and autogenerated raw data would avoid cumbersome activity of document collection and COA preparation
A robust LIMS system has completely configurable sample management workflow. Any Pharma company can use the available workflow and configure it as per their SOP.
In the current situation, where reduction of human presence at laboratories is a requirement, digitalizing and automating the sample management process is the best bet. Most of the processes such as sample allotment, test allotment, etc. can be completed with a click of a mouse with minimum number of people physically present.
Digitalization and automation of sample management process will take Pharma companies another step forward towards Pharma 4.0. An immediate need instead of dream now.