Jose Menezes, CEOEnsuring a high quality of drug production, by proactively identifying and controlling potential quality issues during the development and manufacturing process is a critical aim in the pharmaceutical industry. An effective risk management approach is critical to achieve this by ensuring that quality standards are maintained throughout the product lifecycle. Furthermore, this approach helps pharmaceutical companies gain a better compliance outlook, providing regulators with greater assurance about their ability to deal with potential risks. Set against such a backdrop is 4Tune Engineering, a pioneer in developing intelligent solutions for the pharma industry, focused on operational excellence, de-risking the entire product lifecycle and knowledge management.
The company’s iRISKTM is engineered by a specialist team comprising of QRM experts, IT engineers, and pharmaceutical veterans. “We know your language, understand what you want and are flexible to deliver you the best solution on the market for the pharmaceutical industry,” remarks Jose Menezes, CEO, at 4Tune Engineering. iRISKTM combines all the necessary risk management tools integrated in one platform for risk management throughout the lifecycle. It identifies, quantifies, and prioritizes risks to formulate risk mitigation strategies. It also ensures that the business processes are in tune with regulatory expectations (FDA, EMA, GMP-Annex 15 and ICH guidelines).
iRISKTM can be used to inspect and compare, from a managerial standpoint (via dashboards and custom alerts) every risk management process. Standard procedures can be outlined in iRISKTM, as well as integration with Enterprise Software Systems, making sure that risk assessment and evaluation is streamlined. The onus on the tool is to support risk-based decisions, determine the rights and wrongs and focus users only on the productive risk management activities. In a nutshell, Jose emphasizes that iRISKTM has all the answers that can satiate the queries of enterprise risk management teams.
Dissolving geographical boundaries, iRISK acts a conduit between various risk management teams and professionals spread across the globe. Consider a scenario where a professional is operating from Germany and wants to know the risk perception of his colleague in the U.S. He can seamlessly log into iRISK and gain information about risk management prevalent in the U.S. This not only enables him to harness insight but gives him a platform for knowledge sharing as well.
We know your language, understand what you want and are flexible to deliver you the best solution on the market for the pharmaceutical industry
Ideas along with information can be exchanged through this platform, thereby architecting a robust risk management framework. Knowledge management is the key to iRISK’s success and is further accentuated by this unique features set.
iRISKTM has assuaged many pharma companies from spreadsheet woes and altered their notion about software services. Citing one example, Jose talks about a manager in a big pharmaceutical company, who was struggling to streamline his organization’s growing of risk assessment processes. The budget allocated was huge, and the cost justification was poor. After deploying iRISKTM, the same manager was able to pull the risk assessments and evaluation report of the entire organization with a click of a button. This saved him time, provided a better-informed decision and easily justified the cost.
While speaking about future endeavors, João presses upon the need of proper data management tools. He mentions that the large amount of data that is stored in different silos often becomes extinct. By deploying 4Tune Engineering’s data management tool iSEETM, organizations can witness how the tool makes data come alive. The roadmap for the firm embodies the amalgamation of iSEETM and iRISKTM. And after it is done, the tech world will be endowed with a platform that takes care of risk and data management at the same time.