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LABORATORY INFORMATICS


A standard approach


SOPHIA KTORI CONCLUDES HER TWO-PART SERIES EXPLORING THE USE OF LABORATORY INFORMATICS SOFTWARE IN REGULATED INDUSTRIES


Meeting industry standards can be an imperative for many laboratories, whether working in a


regulated sector or not, points out Simon Wood, product manager at Autoscribe Informatics. However, working to these requisite standards is not necessarily a guarantee of product safety. ‘ISO/IEC 17025 compliance, for example,


encompasses general requirements for the competence of testing and calibration laboratories. Meeting that standard means that you have a well-run laboratory, but it doesn’t demonstrate product safety. A key element of product safety is assurance that data used to make key decisions is a true reflection of the actual data, and has not been subject to manipulation or other human influence. Laboratories must be able to show that workflows have been configured for secure data acquisition, recording and management.’ In effect, a well-run laboratory is the starting point for product safety. Accurate, unadulterated and complete data builds from there. The interaction between different


sectors of industry and their governing bodies also varies, Wood notes. ‘Parts of the clothing industry, which is regulated to ensure that materials meet flammability standards and do not contain potentially toxic dyes or chemicals, for example, have adopted a more collaborative approach, based around the Oeko-Tex Standard 100. This is a worldwide, independent testing and certification system for raw, semi-finished and finished products and accessory materials.’ In effect, as long as all materials used


to produce your garments are certified to Standard 100, then the final product may be accepted as Standard 100-compliant, and require less frequent, or less in-depth


12 Scientific Computing World August/September 2018


regulatory scrutiny of the manufacturing process. ‘There are clear definitions of how to achieve Standard 100 registration, but it’s a more collaborative approach that benefits the entire supply chain.’


Meeting regulation It’s obviously not possible to compare the degree of regulatory oversight relevant to the clothing industry, with that which is required to ensure the safety of pharmaceutical development and manufacturing, Wood comments. ‘Even so, regulators such as the US Food and Drug Administration (FDA), and UK MHRA take a more ‘adversarial,’ stance, he believes. ‘They provide guidelines, but they


don’t tell the industry how to meet their compliance requirements. For example, FDA’s CFR 21 part 11 guidance, which


”There are clear definitions of how to achieve STANDARD 100 registration, but it’s a more collaborative approach that benefits the entire supply chain”


covers electronic signatures. When the guidance was released it caused considerable confusion in the industry, because it didn’t explain what was meant by an electronic signature. For example, it was assumed, by some, that a physical scan of a signature was required; this was not the case. Current data integrity guidelines raise similar questions.’ Enter the LIMS as an infrastructure


for mainstream data management, and it all started to make much more sense, Wood continues. Electronic signatures, audit trails and chain of data custody are embedded in your workflows. This baseline requirement for demonstrating unadulterated data capture and reporting holds true for any regulated industry. ‘The workflows generally adhere to a


common format,’ Wood explains. ‘Whether you are a clothing manufacturer, or making


a blockbuster drug, you still need to manage and test your samples against specifications, collect data from samples and controls, and present that data to your regulator, providing evidence that you are reaching the right standards. The need for data security and integrity, access levels etc. are essentially the same.’ The major differences between industries lies in what the LIMS will need to manage, including the type of information put in at one end, the complexity and volume of data that comes out of the other, and how you present that information to those that need to view it. ‘What these different industries must


also take on board is that the LIMS itself is not compliant, but rather supports their regulatory compliance needs. The LIMS must be configurable to manage the laboratory operation so that capture, management and delivery of information meets the relevant compliance requirements and expectations.’


Choosing the right technology The water industry, for example, will need to set up scheduling plans and complex run sheets for collecting, delivering and testing samples coming from the field, and will need fast turnaround from receipt to testing, Wood notes. ‘Water testing laboratories need a LIMS


infrastructure with the ability to support that complexity of scheduling and provide the necessary analytics and trend-finding to prevent poor quality water entering the consumer pipeline. Laboratories in this sector, in particular, benefit from a LIMS to help them manage work scheduling, so that their staff aren’t under-deployed for long periods while they wait for samples to be delivered. Sophisticated scheduling will also maximise the use of expensive analytical equipment, ensuring a positive return of investment,’ said Wood. ‘It’s about building a holistic system


where all the different pieces work together to accomplish all the different tasks and management functions,’ continues Stephen Hayward, product manager at Dassault Systèmes’ brand Biovia. ‘At Biovia, we offer an ELN that can handle more flexible, unstructured


@scwmagazine | www.scientific-computing.com


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