ANALYTICAL & LABORATORY EQUIPMENT
A LIMS is an invaluable tool for all types of laboratory
also avoids typographical errors through manual data entry. If certificates of analysis are provided these can also be associated with the relevant samples, product, or batch. Adopting this approach ensures that the data needed to make product usage or release decisions is quickly available, accurate and accessible.
An additional benefit is that the data is
testing. To track those samples the internal lab will need to register the samples and provide a barcode so that results from the external lab can be referenced back to the correct sample. Test result data as well as a certificate of analysis may be passed back from the external lab, and these analytical results can be stored in a sample tracking application. Tis allows the in-house staff to check the results and to perform data analysis across samples and/or projects and to derive other information for management purposes. A sample tracking application enables the in-house team to import the data coming from the external lab, keep that data in one database for ease of management, and to perform these reporting functions. Te trade-off between running an in- house lab vs outsourcing the testing is one of resources, cost, speed and confidence. All too often the internal lab is seen as a
cost centre. It requires expensive specialist staff, highly priced lab equipment and costly lab consumables. Using a contract lab can remove these overheads, though the in-house technical/project manager will still need to assess results to be sure product standards are being maintained. With an in-house lab turn-around time should, arguably, be faster and prioritising urgent requests should be simpler. An external lab will always have some latency simply because of the time it takes to ship samples and because of competing requests from other customers, although this risk can be mitigated by ensuring Service Level Agreements (SLAs) are in place. Te trade- off can often come down to how important speed of response is to product release, for example, but may also be down to availability of analytical skills and required instrumentation.
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Potentially, organisations may lack confidence in the service provided by contract labs, and here again the implementation of enforceable SLAs can help. Organisations should, however, be looking at contract testing organisations that meet recognised standards. Te scope of ISO 17025 ‘General requirements for the competence of testing and calibration laboratories’ states: “Laboratory customers, regulatory authorities, organisations and schemes using peer-assessment, accreditation bodies, and others use this document (i.e. ISO 17025) in confirming or recognising the competence of labs.”
A NEW PRESSURE During the current Covid-19 pandemic organisations have been looking at ways to reduce the number of staff on site. While innovative staff rosters and schedules have been introduced, some organisations may have furloughed some, or all, of their analytical staff in favour of outsourced testing. If this is proven to be successful it will further increase the pressure on internal labs. No matter by who or where the testing is done, one of the keys to making the analytical lab work is the management of data. While it is possible for third- party labs to send results and certificates of analysis in the form of files by email to their customers, this can risk inboxes becoming overfilled and vital results being overlooked.
Te alternative methodology is to
provide the information in a format that a sample tracking system can upload directly, and associate it with the relevant samples, product or batch. Tis information is available more quickly as it does not need to be processed manually, and it
available in the sample tracking application and can be used for data analytics. Tis provides further opportunities to investigate trends and outliers, optimise processes and make further cost savings. Statistical process control charts enable sample results within and across batches to be compared to find trends and warn of possible issues before they cause a line stop, or worse. Management charts can be derived from the imported result data showing efficiency of the contract lab through turn-around time charts and other data. Multiple data sets from across the organisation, including the sample tracking application, can be interrogated by data analytics tools to provide even more granularity and flexibility. It is a mistake to think that outsourcing
your lab means you do not need a system for tracking samples and the resulting data. We can call this a LIMS even when an internal lab does not exist. Te heart of every business, the gold dust that enables innovation, is increasingly seen as the data it creates. A LIMS is specifically designed to manage and retain key analytical information, from wherever it comes. Te true benefit is having that data at your fingertips for every batch of every day, together with the ability to access that data in multiple ways. Tis data provides a defendable QC framework for the business, if challenged, and ensures that you can benefit from intelligent use of the data to increase efficiency and profitability. Quite apart from anything else a LIMS removes the nightmare of an in-tray full of unfiled Certificates of Analysis from an external lab and instead records them correctly and automatically against the relevant sample and batch codes for instant recall. A LIMS is therefore an invaluable, indeed essential, business management tool whether your lab is in-house or external.
Tim Daniels is with Autoscribe Informatics.
www.autoscribeinformatics.com
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