➤
laboratory informatics In his keynote speech opening the second
day of the Paperless Lab Academy, David Stokes from the consultancy firm Venostic, said: ‘What will take our industry to the cloud are specialist soſtware vendors providing their soſtware for the cloud.’ Stokes warned that the suppliers of ERP
soſtware, in particular, tend not to address regulatory concerns because they are not specialists in the pharmaceutical industry. Despite its size and importance, the pharma
industry is only one subsector for the ERP vendors. Some providers claiming to be offering soſtware as a service, he said, may in effect only
be running a LIMS from their own data centre rather than on the customer’s servers. In other cases, data security had failed and customers had been able to see each other’s data. However, he said, there were vendors who
understood the regulatory and security concerns and had put the proper controls into their service. Te concerns to be addressed included: quality of the product; the service; the impact on regulatory compliance; patient safety, and integrity of the data. Te issue affects not just the soſtware – whether it be a LIMS or other system delivered as a service. It also affects the infrastructure itself – the outsourced data centre where the application
is being run or the data is being stored also needs to be able to demonstrate compliance with the requirements of IP protection and regulations. Te industry should be careful not to outsource
its IT infrastructure to countries where it would not outsource its laboratory services, he cautioned. Te tendency in the IT industry to ‘buy on price’ is inappropriate for cloud- based services for a regulated industry such as pharmaceuticals, he said. ‘You are responsible for regulatory compliance,’
he reminded his audience. ‘If one of your suppliers screws up, you are still the one who is liable.’
Is the end of the QC lab and its LIMS in sight?
While informatics software vendors are moving on-line and into the cloud, quality assurance is moving in-line.
Tom Wilkie asks what this means for laboratory
informatics software L
ab informatics soſtware faces a challenge from the rise of web and cloud-based services, but it may be under threat from a different direction – not on-line
but in-line quality assurance – the growth of process-analytic quality assurance rather than end-product quality control. Many manufacturers rely on end-of-line
quality control (QC), or ‘quality by testing’. In-line quality assurance (QA), on the other hand, focuses on what happens throughout the manufacturing process rather than taking a snapshot of the output at the end. It thus offers a way of feeding back information while the manufacturing process is continuing and thus preventing errors before they arise. Jan Verelst, from Siemens, summed it up
the trend in one question to the Paperless Lab Academy held in Amsterdam in May: ‘Do we need to stay with the traditional QC laboratory?’ Quality by design (QbD) can be a way
of improving productivity and reducing manufacturing costs. One critical underpinning
6 SCIENTIFIC COMPUTING WORLD
technique is ‘process analytical technology’ (PAT) – instruments and soſtware that makes it possible to measure critical quality attributes and process parameters in-line, allowing running processes to be adjusted in real time. As Verelst put it: ‘While we are making it, we are predicting the quality of the final product. Te lab is no longer needed to measure end-product quality, because it was done in-process.’ Te penalties of waiting for results from the
QC lab were graphically illustrated by another contributor to the Paperless Lab Academy who recounted how one pharmaceutical manufacturer lost a batch of product worth up to $20 million. It was a short-lived product which expired on the quayside while waiting to be loaded on a ship for export. Unfortunately, the certificate of analysis from the laboratory did not arrive until aſter the batch had expired, so it all had to be thrown away. Jan Verelst believes the traditional QC lab
might still have a future at the input end of the process – verifying that raw materials coming from suppliers are in accordance with the specification. However, the meeting heard how medical device company Medtronic was moving in the opposite direction so that, according to the company’s Iraida Quinn, a ‘supplier-owned quality programme’ at Medtronic’s premises in Galway, Ireland, was pushing quality control back to the suppliers themselves. Medtronic has opened a web portal using the
PerkinElmer iLab and a SAP QM connector. When Medtronic places an order through its SAP, the system requests samples that have to be tested by the supplier to check conformity with Medtronic’s specifications and the supplier enters
the results through the iLab portal. Provided the test results meet the specification, the system generates the authorisation for the supplier to ship to Medtronic. Tus the workload on Medtronic’s own QC laboratory is cut back. Peter Boogaard, chairman of the Paperless
Lab Academy, believes changes in the role of the traditional QC laboratory are inevitable and that there are profound implications for its associated informatics soſtware. Quality assurance may indeed be done in-line, he believes, to avoid waiting times for samples to be sent for analysis and results returned to the production plant. Such a change in the role of the laboratory may well bring changes for laboratory soſtware in
IT COULD
MEAN THE END OF LIMS AS A STAND- ALONE PIECE OF SOFTWARE
its wake. According to some observers, it could mean the end of LIMS as a stand-alone piece of soſtware and its incorporation into product lifecycle management systems. But Boogaard believes that there are ways to
prevent the lab from going out of business. On option, he believes, could be for it to switch to problem-solving. If something has gone wrong on the production line, then the lab can create a new and valued role for itself by identifying what has gone wrong and coming up with a solution – moving from routine testing of product to the appliance of science to the process itself.
@scwmagazine l
www.scientific-computing.com
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