LABORATORY INFORMATICS g
some of the risk and the fear out of the process.’ The LabVantage LIMS software
incorporates LES functionality so that scientists can follow electronic worksheets to execute each method. The firm has also packaged tailored solutions of the LIMS solution to meet the needs of specific QA/ QC environments. ‘The LabVantage Pharma package, for example, is preconfigured for use in a tightly regulated pharma QA/QC environment. We created and fully executed all the validation documentation so the platform is ready for use out of the box. This means our customers can significantly reduce all the costs of implementation, because the solution is already validated for use in a regulatory environment.’ Similarly, LabVantage offers preloaded methods for some of the most common tests, so that the customer doesn’t have to build them from scratch. Like many informatics solutions today, LabVantage LIMS takes advantage of cloud hosting, which means that in house and service- related IT costs are greatly reduced. ‘A major impact of cloud computing has been to facilitate mobile applications,’ Voelkner states. ‘Tablet technology is becoming much more prevalent in the laboratory, and in some labs you may not see a PC, everything is recorded using mobile devices.’ This is a trend that is increasing in the QA/ QC environment, just as in other laboratory settings. ‘Mobile technology is enabling ‘observable monitoring,’ for example, for checking microbial contamination in food or pharmaceutical manufacturing environments. Using tablets, you can be very mobile at different sampling points anywhere in the plant.’ The ultimate aim of the QA/QC lab is
to enable release of products that are of the right quality, states Katie Evans, senior product manager at Thermo Fisher Scientific. ‘QA/QC labs essentially carry out an enabling function – routine laboratory sampling and analysis. The aim is to check that the product or output of the production process is actually what it is supposed to be, meeting all specification that the end user or downstream customer is expecting, and so the more seamless the operation of these testing laboratories, the faster the products can get shipped.’ Automation solutions play a key role in optimising lab operation, efficiency and compliance. Intelligent informatics will ensure that labs are testing the right samples, using the right methods, and against the correct specifications, Evans notes. ‘All of that business logic should just happen. It’s not something that people should have to be manually working out. And
24 Scientific Computing World April/May 2018
“Compliance issues and evidence of violation at audit can be bad for image in the marketplace, which can also have financial implications on top of the direct costs associated with falling short of regulatory requirements”
that overall laboratory automation function can encompass everything from alerting people to when samples are coming in, to scheduling environmental monitoring within production areas, scheduling and tracking retests, and managing reagent stocks and ordering’ said Evans An informatics platform has to manage all that lab data, but for a QA/QC operation the software should also guide scientists to ensure that all processes are being implemented correctly, and that the raw data are collated and secured in an SDMS-type platform. This will ensure that the data is future-proofed and available at any point in the future should an audit or recall be necessary’ Evans continued. Serious bottlenecks in product
manufacture and release can occur as a result of out of specification test results or indications that a sample is compromised. The ability to track every action and piece of data can help to help prevent that bottleneck. Highly regulated industries, such as pharma, in particular, must be able to verify that every part of laboratory function meets compliance, as well as verifying that the product meets or even exceeds specifications notes Evans. ‘In the oil and gas industry, for example, an oil product that tests above specification can be upsold as a higher grade, for a higher price.’ Conversely,
if the output is lower than specifications, downstream customers, who are expecting a certain grade or oil, may not accept the product and the producer’s revenues will be affected. It is becoming increasingly common
to outsource QA/QC testing to specialist laboratories, Evans adds. ‘QA/QC testing can be seen as a subcontract part of the main business. Whether that laboratory is part of your organisation or is external to your organisation, you still have to have the same level of confidence in its compliance.’ However you ‘pay’ for your QA/QC, the laboratory is effectively still a cost centre. ‘The flipside of that cost centre financial
drain is that the QA/QC lab is functioning to prevent substandard products from being released, which could lead to recall, and significant financial losses through manufacturing stoppage and potentially fines, explains Patty McDermott, senior marketing manager, digital science at Thermo Fisher Scientific. The firm’s SampleManager LIMS is
used in most sectors that require QA/QC functionality, inclding pharmaceuticals, food and beverage, oil and gas, and chemicals. ‘Our LIMS offers LES functionality, so you have the assurance that when people are running processes in the lab they are running them as prescribed,’ Evans explains. Personnel are guided through each method and process stepwise, from preparing the sample, to loading the instrument.’ SampleManager also incorporates a
fully featured SDMS, which means that customers ‘don’t have to purchase multiple pieces of software, licences and service contracts, and they also don’t have to undertake integration of another informatics system, or carry out additional staff training,’ McDermott adds. ‘This also eases the IT burden with respect to installing, configuring and validating multiple software with standard laboratory practices. It’s not just a cost issue, it’s a time issue as well.’
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