Since its founding in 1982, the NYSE-traded American multinational company, IQVIA remains committed in accelerating innovation for a healthier world. This time, it has expanded its technologies to target dreaded recalls and uncomplicate standard operating procedures (SOPs) for streamlined execution of recall management.
Status Quo on Product Recall
Reliance on laborious and antiquated recall procedures has contributed significant delays in destructive, defective and/or violative product reacquisition. Such processes proved not only time-delaying but more importantly over-burdening internal teams responsible for the reacquisition resulting to negatively impacted core activities. And this happens even to pharmaceutical corporations with the most stringent of protocols set in place. This shows that the impacts of product recalls to businesses remain underestimated, if not unseen.
FDA Recall Classes and Call-to-Action for Improvement
The Food and Drug Administration (FDA) categorizes product recalls into three classes: Class I Recall is for seriously injurious or lethal products, Class II Recall is for seriously injurious or temporary illness-causing products, and Class III is for non-injurious or non-illness-causing products but such products did show grave violation(s) of FDA regulations.
With the regulatory topography demonstrating imperturbable evolution, it is imperative that medical technology (MedTech) companies establish an optimized program with features of convenient worldwide implementation all while incorporating and putting premium on unparalleled speed and unquestionable accuracy.
IQVIA’s Response to Antiquated Recall Protocols
IQVIA enters the scene with such a powerful stance, as it implements a ‘flexible, outsourced, global solution for the management and execution of recalls and field actions’. The IQVIA MedTech Recall and Field Action Program prides itself with a validated, CFR-11 compliant program capable of providing a central data repository that monitors, organizes, and gauges tasks performed in lieu of your absence. The IQVIA technology is a modern means for collection of responses, delivery tracking monitoring, and social responsibility or due-diligence efforts, all while aiming for a well-concerted, collective, and pellucid documentation and reporting for both internal analysis and regulatory submissions.
IQVIA’s support activities are inclusive of, although not currently exhaustively listed as follows: digital and physical notifications, acknowledgement response electronic collection, business call process outsourcing on a global scale, processing of product returns, warehousing, proper product destruction and disposal, and on-site remediation deployment of biomedical field service teams.
Paving the Way for Streamlined Recalls
Partnering with IQVIA MedTech has resulted in surmounting constraints involving internal communications and burden reduction of handling the intricate daily aspects of a recall. It has augmented trust in acquired data from reports about the recall status, secured real-time updates on recall statuses, and acquisition from a singular trusted data source is guaranteed. Finally, consistency will never be an issue in IQVIA MedTech deliverables with the ISO 9001:2015 certified quality management systems credential on its arsenal, thus, lowering internal selling, general and administrative (SG&A) expenses with an external remedy to accommodate an unanticipated necessity.
IQVIA remains to be one of the world’s largest contract research organizations (CROs), this goes without saying that its influence goes a long way. And it is always good news to know that IQVIA advocates social responsibility integration in its technological implementation.
Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE
Editor-in-Chief, PharmaFEATURES
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Web Media Acknowledgements
(1) The above posted FDA Drug Recalls modified infographic was taken from an Advocacy News article from the Hemophilia Federation of America entitled Understanding FDA Drug Recall Procedures. The original basis for the slightly altered image was retrieved on 04 Nov, 2022 from https://www.hemophiliafed.org/uploads/FDA_recalls_infographic.jpg.
(2) IQVIA Logos, Computer Monitor and the Diagrammatic Representation were taken from IQVIA’s Fact Sheet entitled IQVIA MedTech Recall and Field Action Program. The images were retrieved on 04 Nov, 2022 from https://www.iqvia.com/-/media/iqvia/pdfs/us/fact-sheet/2022/iqvia-medtech-recall-and-field-action-program-fact-sheet-2022.pdf.
(3) IQVIA Connected Intelligenceâ„¢ Promotional Banner image used in this article is taken from IQVIA’s Fact Sheet entitled IQVIA MedTech Recall and Field Action Program. The image was retrieved on 04 Nov, 2022 from https://www.iqvia.com/-/media/iqvia/pdfs/us/fact-sheet/2022/iqvia-medtech-recall-and-field-action-program-fact-sheet-2022.pdf.