Camsoft CRM Solutions, a local consultancy solutions provider based out of South Africa with a rich experience of more than 25 years in the industry, recently broke the news of the launch of MaxPharm, a Pharmacovigilance CRM system.
What is Pharmacovigilance ?
As per the WHO (World Health Organization), Pharmacovigilance (PV) is described as the science and activities related to detection, comprehension, assessment, and prevention of unfavorable effects or any other drug-related issue.
The WHO primarily created its Programme for International Drug Monitoring in response to the thalidomide disaster first detected in 1961, and the FDA (Food and Drug Administration) Software and Equipment validation during the outbreak of the Therac-25 radiation treatment accident.
In essence, what occurred during that particular case was that user input was not being controlled and checked, and the machine output was way too high compared to the safe limits. This ultimately resulted in a deadly effect in certain cases. On the other hand, if the validation exercise was followed, the event was unlikely to have occurred.
As per Mark Annett, Head of Camsoft CRM Solutions, the primary objectives of pharmacovigilance are to improve patient care and safety in terms of the use of medicines, in addition to supporting public health programmes by delivering reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
He states that Camsoft CRM Solutions, in partnership with the major pharmaceutical companies, has created the MaxPharm CRM software application to manage, report on all phases of patient advocacy and communication programmes.
Software applications in the industry should be validated as this is the best way to reconfirm accurate results or reports and improve patient treatment efficacy.
MaxPharm also deals with reports on adverse episodes during the treatment cycle. Mark Annett commented, “The success of the solution is as a result of the built-in features which offer cloud and mobile access, one-click reports and dashboard delivery, among other things. And this is together with built-in adverse event reporting systems and outstanding local support. When an adverse event is logged in the system, MaxPharm ensures all stakeholders are immediately notified via e-mail or text message.”
Furthermore, the system requires a response to ensure case escalation if the response time is not as prescribed. Inbuilt intelligence has the potential to warn professionals when they engage with newer patients, and their history is made available at the click of a button. Post which, all the information gathered is collated and presented as dashboards or traditional reports.
Therefore, the result is a comprehensive industry-focused app that is configurable and validated under the US FDA guidelines.
Thus, validation is an essential step in the software implementation process, particularly in the pharma sector, as it confirms all the parties involved that the data flow is flawless and free of any output irregularities. The validation also translates that the system is ready to be used worldwide and will be approved by authorities and auditors virtually.