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Life Sciences & Pharma
The digital transformation of processes in these specific markets has led to the automation and digitalization of all business processes, with particular attention to the production department and Quality Assurance. Digitalization in these sectors has allowed companies to equip themselves with new methods in the management of activities that were previously managed on paper. This has made it possible to speed up the management of procedures and daily workflows, while ensuring the quality of products in compliance with good manufacturing practices (GMP and GXP) imposed by national and international supervisory bodies
Supporting this market for years and providing them with a platform adapted to all relevant national and international regulations, we have acquired a deep knowledge of the processes that characterize it, as well as a strong 'vertical' competence in the different types of drug manufacturers. Every day we face companies like these that have decided to face a digital transformation process which leads them to govern critical processes better, where people from Quality and Production interact. The pharmaceutical world and the whole Life Sciences sector must give certain answers and targeted and controlled activities first of all to "internal customers" even before external customers. The uniqueness of the data and its traceability even before its context is fundamental. The pharmaceutical company "lives" from certain structured processes and has the vital need to confront and side with partners and expert consultants who can accompany it to face the organizational and efficiency challenges that their market requires.
The GMP & GXP Digital solution
The standard aims to allow the widest possible use of electronic technologies and consists of two main sections: electronic records and electronic signatures. These two main sections are a natural extension to the traditional use of paper records and offer the same or greater level of security than manual signatures
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"Customer Complaints" Solution
The platform is in use by all companies in the group, so the flow is both multi-site and multi-company.
Amongst others, the "Customer Complaints" management process has been implemented; the solution is able to follow the different phases of the process from the collection of the report, to the investigation, up to the opening of possible corrective actions, also involving pharmacovigilance, when necessary.
The flow is validated according to Annex 11 and CFR 21, hundreds of users are involved.
"Technical Customers Services" Solution
In the face of any customer request (laboratory analysis, documentation, specific processing) even with different origins, the system allows precise tracking and commissioning of the request, to different company bodies, depending on the complexity.
Each request can be followed by a series of activities, parallel or sequential, mapped to the system; all ends with the fulfillment of the customer's request, fulfillment that remains traced to the system.
The process has eliminated inefficiencies and/or delays and has also enabled a statistical survey that is very useful in terms of customer support.
Success Stories
Best practices are the result of expertise, experience and customer engagement
Digitization of Master Batch records and operational processes
Digitization of Batch records for optimization and efficiency of operational processes ...
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AMS: Archive Management System, Document Archive Digitalization
Management and mapping of the physical archive of documents, folders, elements managed ...
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Digital Management 4 Change Control Paperless
Managing the "Change Management" quality flow in completely a paperless way.
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