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RegTech provides exclusive opportunities to organizations that are looking for creative methods to reduce their compliance budgets while meeting the directives of governing agencies.
FREMONT, CA: In the past few years, there has been an increasing demand for safe medical devices. Nowadays, billions of people depend on the marvels of modern science and engineering, ranging from implants and prosthetics to diagnostic tools and software to achieve a long and healthy life.
The first emergence of RegTech was witnessed after the economic plunge of 2008. The financial disaster encouraged an increasing regulation in the finance and banking industries, and as a result, many companies started shelling out more money in compliance costs. To stay compliant while working within the framework of limited resources, maximum companies began to seek help from regulatory technologies. Since then, industries have witnessed dramatic growth, and it is expected to escalate more by 2030.
RegTech has every potential to transform the process in which compliance is managed along with regulatory reporting and risk and identity in Pharma. Generally, RegTech refers to the usage of new and improvised technologies such as Blockchain, Artificial Intelligence, Big Data, and Cloud Computing. The evolution of the latest technologies increases the diversity and size of industries and solutions it serves. Recently the RegTech firms have been boosting their services of automated compliance management, risk and identity management, and regulatory reporting in industries like environmental protection, crypto-currency, healthcare, and cybersecurity.
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The five primary areas within the compliance function where the smart use of technological solutions can provide benefits to the Pharma companies are as follows.
1. Compliance Readiness and Audit
The compliance consists of all activities such as internal audits, verification programs, third-party audits, and much more. The company can stay ahead of the regulatory curve if they determine the organizational readiness to tackle new regulations by continually evaluating the employees at an individual and a team level.
2. Training and Communication
This includes activities that allow pharma companies to train or create awareness regarding external factors like new regulations, internal organization policies, and related procedures such as communications with employees, contractors, and business partners. The culture of readiness will be created if the company uses the readily available industry resources for training and guiding the teams as per necessities, and continuously update their training procedure.
3. Program Management
When a company has proper expertise and guidance during the product development stage, it can save them a huge amount of money by fixing the compliance issues much earlier in the value chain.
4. Data Security
Implementation of control systems, professional security staffing, and backup, and disaster recovery helps a pharma enterprise in protecting their information assets.
5. Data Policies
The events in it are associated with the creation and dissemination of the policies that are relevant to the protection of confidential information, such as financial information, customer data, employee record, and more.
The technological solutions provide a unique opportunity to the pharmaceutical companies who are looking forward to reducing the non-compliance penalties while continuing to meet the directives of the regulatory agencies reliably. The usage of technology in the pharmaceutical compliances may be at an early stage, but it has a promising future.
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