Relevant aspects for the Companies operating in the Pharmaceutical sector, and subject to be compliant to European and US pharmacovigilance rules, are data security and personal sensitive data treatment.
This topic, already significant with ICH ISR (R2) rules, will be more and more relevant with the forthcoming introduction of the new R3 version.
With the awareness of the great advantages of using SafetyDrugs® Pharmacovigilance platform in Software as a Service (SaaS) modality, since long time first choice of our customer base, we have decided to increase the warranty we can offer to the market, by getting an instrument that could connect the required personal data level of protection, directly with the technical project of SaaS, and its functionalities.
So we achieved that Privacy by design and Privacy by default were words that had to be fulfilled (filled)with contents.
The first step was to require the support and legal advice of Colin – Consulente Legale Informatico (Informatic Legal Consultant), a major consultant legal firm in information technology, and to obtain the “SafetyDrugs® privacy compliance”.
The second one was to integrate into a solid contractual structure the “Privacy Level Agreement”, to propose to our customer together with the “Service Level Agreement”.
Synthetically, the topics treated in the PLA are related to: Sensitive and personal data processing; Data transfer; Security measures; Third party certifications; Portability, migration, and guarantees for transfers; Retention, return and cancellation of data.
Improving transparency, lightening the expensive and time-wasting system validation activities, simplifying the pharmacovigilance process, are our main objectives.
We believe that the Privacy Level Agreement represents a further step in this way.