By Leonardo Fullone, Pharmaceutical Innovation Manager of Verifarma
The pharmaceutical industry is already talking about the “network-integrated laboratory 4.0” as an unavoidable evolution towards which the organizations of the sector must go, if they are willing to stay competitive. The digital tools to become intelligent laboratories, transforming management to make it more efficient already exist and are accessible.
At present the Coronavirus pandemic is leaving us a clear message: it shows us how vulnerable economy, industry and the world as a whole are. And the pharmaceutical sector, even if it is considered as essential, has also had to adapt itself. The companies of the sector need to maximize their profitability and make the most of all the existing resources to transform themselves without losing sight of the need to comply with increasingly demanding regulations and maintain the non-delegable commitment with patients, by delivering them safe, efficient and quality products.
Within said context, the tools like Verifarma Integrated Solutions became one of the main allies to move on in the transformation. But, however, how can we make a full Good Laboratory Practice (GLP), use more efficiently the resources, reduce costs and comply with all the regulations?
The possibility to carry on management with tools that digitally manage the integral operation of the laboratory today is a fact. We talk of integral tools that allow to manage efficiently the handling of supplies and samples, authorizing the administration and control of stocks, making wise purchases, avoiding expirations and having complete traceability. And that may allow also to have the equipment electronic logs, recording all the activities of maintenance, calibration, etc.
Due to the fact that the electronic and digital systems must comply also with the 21 CFR part 11 regulations, we will be under a security framework that will offer us the relief that audits will be borne very well.
Information, calculations and KPIs
Digital tools allow also a more efficient and timely management of the information arising from the tests –in organizational aspects, trends and results-. The fast and timely access to information allows us to efficiently take smarter decisions.
On the other hand, nowadays the calculation systems in the laboratories are one of the most vulnerable items, since the worksheets are unsafe and lack the appropriate validation. Therefore: such tools as Verifarma Integrated Solutions allow also to make reliable and secure calculations in a validated environment and integrated to the analytical instruments generated by the primary data, with the possibility of handling reliable, exportable and traceable results. All this integration turns the laboratory not only into more efficient but allows its operation within a full GLP environment.
Another aspect in which digital solutions may make a key contribution is the efficient stability testing planning and management according to the ICH guidelines. Usually, if there is no system guaranteeing that the stability testing is under an efficient environment, probably we will run out of samples at the halfway stage, for example. Therefore, it is essential to have a tool that tells us when and at what point testing must be carried out, that may offer an organizational framework to define strategy, the testing protocol and the environmental conditions, where tasks are assigned, a review and approval system is ordered, having an integration with inventories. And the same applies for managing results, tendencies and reports related to these testing.
Finally, there is the issue of the key performance indicators (KPIs) -namely, of metrics that help us to identify the performance of a certain action or strategy-. Having a digital tool that may take the stored data and generate KPIs, obviously taking the data from the same system, provides an invaluable visibility to set a system of continuous improvement as an engine management.
In short: digital tools in an integration environment enable the progress towards the concept of 4.0 laboratory. Having these solutions shall allow us to have an efficient, integrated, regulated and paperless management. Organizations joining this change early, may be positioned with clear advantages in terms of the future.