Our values / Our Quality policy
We are above all a publisher of regulatory softwares. This activity obliges us to provide our partners and customers with IT tools that are always in line with the regulations in force (related to health vigilances). Anticipating regulations in order to better implement them in our software is one of the pillars of our policy.
But a company that is open to the world is a company that innovates. What is the point of focusing its communication on database outsourcing when all databases are nowadays outsourced? Innovation is not to propose what has become the norm, but to propose innovative tools to meet our world challenges: Applications for smartphones and tablets enabling the rapid and secure transmission of side effects; "crawling" software allowing the detection of side effects that have never been transmitted to health professionals but are nevertheless present on social networks... Pharmacovigilance today needs to think in terms of "pharmaco-surveillance" for a more global approach to the risks associated with health products.
Our tools must therefore be innovative but always in line with all regulations, whether business (E2B) or security (GDPR). The GDPR is all the more important for us as it provides a regulatory framework for the design of our different tools: reliable and secure data transmissions (HTTPS); approved hosting for health data (HDS); a verification of systems and the data integrity (21 CFR PART 11).
Thus, regarding our mobiles applications, we have made them evolve in order to put the main interested party (the user) at the center of our concerns: All our applications comply with “data portability” policy that allows everyone to retrieve the data they need. '' it generates, as well as a "confidentiality" policy that guarantees the anonymization of personal data.
In order to fulfil our mission and provide quality applications and associated services, our Quality & Validation department has, since its inception, represented 30% of our staff.
Its tasks are closely linked to the implementation and monitoring of very specific procedures: Register of processing operations + Impact analyses relating to data protection + Supervision of transfers for our partners outside the EU (for all documentation relating to personal data) / Information notices + Collection of consent from individuals (for information relating to the users of our systems) / Contracts with subcontractors + Implementation of procedures in the event of a possible data breach (in order to clearly define the roles and responsibilities of the actors).
But a Quality policy must above all be honest and sincere: Our aim is not to propose an innovation at all costs (and at a high price), but a useful innovation above all and at a price that is accessible to the greatest number of people. Fair costs and therefore easily accessible, and that are fully in line with the evolution of the market (a simple question: Does it make sense to pay more and more for databases when all hosting providers are offering cheaper and more secure solutions)?
But innovation, regulation and honesty are not everything.
In a more general way, Quality also means knowing how to avoid any tension in order to create a relationship of trust with the companies that support you: above all, being attentive to their needs (and therefore being responsive); knowing how to help them for example with (setting up our "Validation and Quality" days); knowing how to guide them in the evolution of regulations (setting up our "User Club"); offering them other ways to consider their job (creation of the "Pharmacovigilance Academy").
eVeDrug is strongly committed to satisfying the needs of its partners and clients.
For my part, I am committed to ensuring that everyone applies, and proposes, continuous improvements to meet these needs.
Claude Touche - CEO
Our Quality policy
eVeDrug offers you optimal quality management in accordance with the provisions of french law n°78-17 of January 6, 1978 (known as "IT law and freedoms") and the General Regulations on the protection of Personal Data (“RGDP”) n°2016/679.
Regarding the Validation section of your computer systems, eVeDrug offers you:
- Delivery of the IQ and OQ file (installation qualification and operational qualification)
- Help in getting started and finalizing this validation dossier
- Assistance in the preparation of validated maintenance documents
Please note that the modifications requested in relation to your processes and needs, or those of a regulatory nature, are subject to an annual Change Control. Our partners are invited each year to a special Change Control day intended to fully understand all the features implemented.
- Support in the event of an inspection