In today’s fast-paced business environment, companies are constantly seeking ways to enhance their processes and improve team efficiency, and in doing so inevitably seek out technologies that enable them to do so. As technology plays a vital role in achieving these goals, organizations often face the decision of choosing between custom-made solutions or opt for a commercial-off-the-shelf (COTS) solution. This holds particularly true for companies in industries that increasingly rely on technology to support the tracking and management of regulatory requirements, such as the Pharmaceutical and Biotech Drug Safety companies. This article aims to explore three factors that can help companies make informed choices by comparing the benefits of Orbit, a COTS solution, with custom-built solutions.
Custom-Built Software
Custom software is built from scratch with unique solutions tailored specifically to the company’s needs. This can be particularly important for companies with unique business processes or requirements that cannot be met by off-the-shelf software. Generally, these solutions are developed in-house or outsourced entirely. Often this development process is very labor-intensive, costly, and is up to the business or third party to design, develop, implement, and maintain the software, including upgrades, bug fixes, and general on-going support.
Custom software is made specific to the business and isn’t configurable. Any changes to the software must be made through a development process. This involves significant time and cost in designing, developing, testing, and deploying the new system. Often a developed, in-house solution can take anywhere from 12 months to several years to deploy.
Orbit, A Commercial-Off-the-Shelf Solution
In contrast, a commercial-off-the-shelf (COTS) solution is designed to be configurable. COTS offer pre-built technologies that can be customized to meet specific requirements and processes, in a cost-effective and timely manner, typically ready to use with minimal customization so companies can quickly implement the software without significant delays. The Orbit software provides pre-validated, subscription-based Pharma and Biotech Pharmacovigilance and Regulatory solutions that can be deployed in the cloud. With risk always knocking, time-to-market for implementing and deploying solutions is essential and having a proven, pre-built solution that has been developed and tested by experts in the industry is gaining traction for pharma companies, big and small.
Time-to-Market
COTS solutions are faster to implement than custom-built solutions. Because COTS systems are pre-built and pre-configured, they can be deployed quickly with minimal customization. This means that companies can get their systems up and running faster than if they were to develop, test, and deploy a custom-made solution. An Orbit project typically takes 4-6 months, whereas a custom developed solution can range from 12-36 months. This can be especially important in industries like Pharma and Drug Safety where time-to-market is critical to remain competitive.
In Orbit, customization of things such as workflows, predefined tasks, review cycles, permissions, notifications, oversight, etc., are customizable and can be modified to fit your company-specific jargon. The Orbit system has configurable fields and languages, so whether you speak Korean, German, or English, the system allows for custom translations.
Ongoing Support and Maintenance by the Experts
One of the biggest advantages of a COTS solution is on-going support and system maintenance. Orbit is developed and maintained by the experts who have extensive knowledge and experience in the industry, allowing companies to rely on the expertise of IT professionals to provide support and maintenance, ensuring that it’s up-to-date and functional. Additionally, Orbit software is constantly being improved upon, informed by feedback from existing customers and changes in industry requirements. This on-going development and support model allows pharmaceutical companies to focus on their core business activities rather than on software development, maintenance, troubleshooting, and validation.
Moreover, with Orbit, customers have access to community knowledge and improvements as requested by other users. When Orbit implements customer requests, it’s because we believe they’ll benefit all of the Orbit community. These upgrades are then plugged into future releases of the system. As you can see, our customers drive the system innovations. With Orbit you get the benefit of Pharma Industry Leaders’ experience without having to code the software.
Regulatory Compliance
COTS software is designed to meet regulatory requirements out-of-the-box, which is a critical requirement for pharmaceutical companies to bring and keep drugs on the market. Orbit is kept up to date with the latest regulatory requirements set forth by regulatory bodies such as the FDA and EMA. For example, a company might use Orbit for managing its clinical trials, with features such as adverse event reporting, electronic data capture, and audit trails, all of which are validated and GxP compliant.
As the global healthcare industry continues to evolve and grow, pharmaceutical companies face increasing regulatory complexity and scrutiny. The challenge is in navigating the complex regulatory frameworks and keeping up with the pace of innovation in the industry. With Orbit’s specialized team of engineers, it’s one less problem to think about when your system is in the hands of the experts who built it.
Conclusion
When it comes to managing processes in the pharmaceutical industry, utilizing modern technology strategies is crucial. However, before implementing such strategies, companies must decide whether to build their own system or buy a pre-built one. Unfortunately, many organizations overlook the option of a pre-built, validated system and can run the risk of delays due to the intensive time and resources necessary to develop, test, and deploy a custom solution.
Orbit offers pharmaceutical companies a more convenient, cost-effective, and pre-validated solution to ensure regulatory compliance. The time, customization, and on-going support are all benefits of a COTS solution, with the biggest benefit in being a part of our Orbit community. Our developments are responses to our users’ needs and the rapidly changing industry. Our goal is to help you and your teams modernize the way you work so that your team of experts can focus on their core activities – ensuring the safety and efficacy of drugs and medicines, which is at the heart of what this industry stands for.
