Pharmaceutical industry
Demanding drug discovery processes, auditability, full market approval, the list goes on and the regulation of medicinal products increases constantly. Any infringement of Good Manufacturing Practice (GMP) found during an inspection by a supervisory authority has an immediate impact on your revenue and your profitability. You do however still need to innovate, and to move fast.
As a laboratory or manufacturer in the pharmaceuticals sector, you conduct your business within an extremely strict regulatory framework. The overriding need to be profitable and competitive is pushing you to re-evaluate your strategy, in particular with regard to digitalisation and management of your information flows.
This is a major challenge because your processes are increasingly cross-functional, spanning research & development, quality, compliance, purchasing, production, logistics, human resources, etc. and they are also open to external partners. In addition, if you are using a great many applications, your IS is built on the links and interchanges between all these systems, in place so they can serve the business processes.
01THE PITFALLS
The challenges posed by changes
in pharmaceutics and its digitalisation
With XEVMPD (Extended EudraVigilance medicinal product dictionary), UDI unique coding, ISO/CEI 17025, CFR, and more, effective and verified data management is crucial to meet regulatory requirements and follow GMP.
Provide complete traceability
With nomenclatures, designated pharmacists, version history and more, you must be able to reconstitute the product’s master data for any date, and trace all changes made.
This is the MDM (Master Data Management) aspect
Audit processes
Process auditability is vital in the pharmaceuticals sector. It is directly linked to your right to manufacture and sell medicinal products!
This is the BPM (Business Process Management) aspect
Re-engineer data traffic between applications
Your quality management systems, MES (manufacturing execution system), LIMS, WMS, etc are all critical. You need all these applications to communicate flawlessly, with all necessary checks.
This is the ESB (Enterprise Service Bus) aspect
Manage interchanges with the outside world
You increasingly need to open your information system to partners and subcontractors (subsidiaries, laboratories, start-ups, etc.) while retaining control over every interface and every piece of data carried.
This is the API Management aspect
02METHODS AND SOLUTIONS
What methods and solutions deliver the best response for digital transformation in the pharmaceutical industry ?
The application bricks that form information systems in pharmaceutics companies are generally of a high standard, and also fairly numerous. However, while this best-of-breed approach to each type of system (WMS, LIMS, MES, CRM, ERP, etc.) might be the first response to your challenges, it cannot be the only response.
The auditability of your information system, complete traceability of data flows, and compliance with standards all mean you need to re-engineer your entire system and set up cross-functional processes operating between applications both internally and with the outside world.
While IS re-engineering is, in the first instance, justified by quality standards and compliance, it is also an opportunity to take a further step forward in your digital transformation and improve your productivity and agility.
You need to be able to answer these questions at any time. Where is this data from? Am I certain it is up-to-date ? Who confirmed it ? Why is it being used in the live environment ?
Blueway quickly gave us independence, and improved our response time to customer requests.
Blueway quickly gave us independence, and improved our response time to customer requests
03 THE BLUEWAY SOLUTION
Blueway’s approach to digitalisation in pharmaceuticals
We have been supporting and guiding pharmaceutical companies in their digital transformation for many years. We are consequently fully aware that IT is only one way to meet your challenges:
- Operate a standardised and controlled data interchange environment
- Remove the risk of errors (data re-entry, ratification, stages in processes, real-time updates, etc.)
- Supervise all data traffic, both internal and external
- Meet auditability obligations, comply with standards and follow procedures.
Our customers in the
pharmaceutical industry include :
In response to the crucial challenges posed by control over data flows and processes, Blueway offers a comprehensive solution through its software platform, specifically designed for pharmaceutical companies. The platform incorporates all aspects of data interchange (BPM, MDM, ESB and API Management).Processes are documented and tests can be reproduced in the event of any problem.
Full-web, and available on-premise or hosted as SaaS, our integrated platform connects natively with the main systems used in the pharmaceutical industry (WMS, LIMS, ERP, MES, etc.). You gain a 360° real-time view of your processes and supervision tools to issue warnings whenever an incident occurs and to monitor your performance indicators.
Auditability of processes
Optimisation of purchasing/invoicing/ordering data flows
Enhancing your use of data
Information continuity from laboratory to production (LIMS-ERP)
Serial numbering of medicinal products
Data Foundation
Application bus
Api Governance
Module designed for API Management
Enhancing your IS
Process Governance
Workflow design package
Data Governance
Module designed for master data repositories
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