Software for satisfying rigorous regulations
Paper records are no longer good enough; only an electronic informatics system will satisfy regulatory requirements, as Sophia Ktori discovers
O
ver recent years the regulations surrounding the pharmaceutical, food and beverage, and environmental industries have
started to converge in terms of the breadth and level of data that is expected and required of them. According to Colin Turston, project director at Termo Fisher Scientific: ‘FDA is rolling out pretty much the same style of regulatory requirements for the food industry that have been in place for many years in the pharmaceutical industry.’ A number of the ISO standards, such as the ISO 14000 and ISO 22000 family of standards for the environmental sector, and for the food and beverage industry, respectively, have a lot of features that are similar, although there are nuances for each particular market, Turston continues. ‘What this means is, that if you are in either of these industries, you can look at the life sciences sector to get an indication of how regulatory requirements will likely evolve, and soſtware providers can increasingly make use of tools that have been in place for traditionally regulated industries, such as the pharmaceutical sector, in areas including environmental testing and food safety testing.’
Backing up your claims Consider, for example, a human drug, continues Gene Tetreault, senior director of products and marketing at Dassault
4 SCIENTIFIC COMPUTING WORLD
Systèmes’ Biovia. Tat drug must be manufactured to satisfy the claim that it contains a particular ingredient, at a particular potency, and is produced using a certain manufacturing process. You have to back up all those claims every time you manufacture that drug. You need proof that all the right procedures and processes are in place, that they are followed correctly, that you can track the provenance of the ingredients and that, when samples of that drug are taken for testing, you follow each stage in the workflow, from sample collection to the generation and reporting of results. Te requirement to track and validate the entire manufacturing process and testing workflow are similar for a drug, a foodstuff, or for the processing of clean water.’
Holding hands Ideally, soſtware designed to satisfy regulatory issues should also offer fail- safes and controls around the data itself, Turston continues. ‘Te laboratory execution system (LES) that has been launched to sit with Termo Fisher’s SampleManager LIMS, for example, monitors training records for users and prevents the system from assigning work to someone who is not authorised to use a particular analytical instrument or process. Tis is the type of feature that regulators are now requesting.’ Showcased
at Pittcon in March, the LES offers the option to lead users through each step of a laboratory process, to ensure that each is being followed correctly. ‘Tere is a series of levels, from beginner to expert, to offer different degrees of hand-holding. What this capability also means is that if the regulation on how to measure a particular pesticide, for example, changes, then you can build the new process into your system and the lab execution function will ensure that personnel are following the correct new workflow without extensive retraining.’
THE REQUIREMENT TO TRACK AND VALIDATE IS SIMILAR FOR A DRUG, FOODSTUFF, OR CLEAN WATER
Termo Fisher has also launched a fully
integrated scientific data management system (SDMS) that provides the ability to integrate and centralise data from disparate instruments and display specific data files in a common format. Tis facilitates data mining, sharing, and analysis across and between departments and laboratories to collect and collate data satisfying regulatory requirements. ‘LES and SDMS incorporated
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