Pharmaceutical manufacturers face many challenges in business, and one of the biggest is regulatory compliance. Unfortunately, navigating complex legal requirements can take resources away from the core business.
When it comes to documentation in the pharmaceutical industry, it is imperative to be compliant. From privacy to reporting requirements, document management for pharmaceuticals is a must. A high-quality document management system can make a significant positive impact on the business, making it easier to stay compliant while streamlining processes.
Compliance is Critical
Patients rely on pharmaceutical companies for life-saving medicines, there’s no room for error. Regulatory rules and guidelines are there for a reason: to protect the public. Ignoring these governmental laws can not only lead to hefty fines in the millions but can be a public relations disaster – not-to-mention the real cost of human suffering.
One of the essential regulations impacting documentation in the pharmaceutical industry is HIPAA (the Health Insurance Portability and Accountability Act of 1996). There are three main areas that HIPAA covers: administrative, physical, and technical. This includes measures to ensure patient data is correct and accessible, measures to prevent the physical theft of any devices containing electronic patient data, and technology-related measures to make sure that all networks and devices are protected from and data breaches. A document management system (DMS) is a great way to address all three areas of compliance.
6 Benefits of a Document Management System for Pharmaceutical Manufacturers
A DMS is a software solution that manages electronic documents, files, and scans. Depending on the system, the DMS may provide organized workflows and tracking systems to make it easy for administrators to monitor document usage and sharing. A DMS that is run via managed software solutions is administered and supported by a company specializing in such software. The benefits of a professionally managed DMS include:
1. Worry-Free Compliance
With constantly changing regulations, having software that is updated and current on all pertinent regulations can save time and money. This is especially important for drug research and testing and clinical trials, which require strict privacy and accuracy of data. Your provider will keep you compliant so you can focus on your business.
Security is critical for regulatory compliance, as there can be no such thing as “real” privacy in an unsecure system. Furthermore, reliable document security during drug research and development is imperative to staying ahead of your competitors.
Consider the number of compounds typically reviewed and researched as possible drug components by discovery research scientists. With thousands of possible compounds and combinations, keeping track of this research requires a strong system that can handle the information. Document management systems can facilitate this process through appropriate workflows and tracking.
4. Cost Savings
Bringing a new drug to market takes years and can cost billions. Once that drug is released to the market, there may be just a short window of time before the patent for exclusivity expires. Once that happens, and generic versions of the drug are available, a company can lose 75 percent of sales.
The patent of exclusivity starts when the drug is being developed, not when it is finally launched on the market. Therefore, the more efficient the drug-making process is, the more profits a company can see. Streamlined documentation in the pharmaceutical industry can make a massive difference in the time it takes to get a new drug to market.
Creating a new medicine requires a lot of collaboration, from the science and research teams to the doctors running clinical trials, to the marketing team getting the product ready for the market. A document management system can facilitate this process by creating a secure and efficient way to share information and store information.
6. Easy Tracking and Reporting
One of the most significant benefits of a DMS is its ability to track and monitor documentation automatically. This automation would have been previously done manually by staff, taking much more time and resources – and with more risk of human error.
Automated Documentation in the Pharmaceutical Industry
With the right document management system, collaboration, document tracking, and reporting can be centralized and automated. This improves efficiency while enabling pharmaceutical companies to focus on core business goals.
At DOCUmation, we pride ourselves on being thought leaders in the managed software solutions industry. We are experts in document management solutions that improve security, increase efficiency, and ensure compliance. Contact us for more information on how we can help your business.