Complex, and ever-changing regulations are a major challenge in the healthcare industry, meaning hospitals, pharmaceutical companies, and health systems must pay closer attention to compliance, security, and governance than ever before. At the same time, the amount of data generated continues to grow in volume and complexity, which means industry stakeholders must be equipped with the proper tools in order to adapt.
Healthcare organizations are using new models of digital technology such as Regulatory Information Management Software (RIMS) to deliver high-performing solutions that respond to the information demands of the business, but simplify management of compliance processes. However, providing these capabilities without sacrificing efficiency during medical review processes remains a major challenge for healthcare and life sciences companies everywhere.
What many life sciences organizations may not realize, is that innovative solutions already exist to fill the technical gaps they may be experiencing at each stage of healthcare document lifecycles — whether for pharmaceutical product development, clinical research document management, or management of medical records.
This blog introduces the concept of high-speed document viewing as a solution to streamline authorization processes and workflows for pharmaceutical and medical device companies.
What is RIMS?
To bring pharmaceutical products or medical devices to market, healthcare companies must submit a medical market authorization application to the competent authority for assessment based on strict criteria relating to quality, safety, and efficacy. Regulatory Information Management Software (RIMS) streamlines the submission process of pharmaceuticals, biologics, or medical devices to regulatory agencies in order to gain authorization to sell the said product.
A productive RIMS organizes the work needed to obtain approval to sell human medical products. With differing regulations and requirements based on geography, types of products or devices, product lifecycle stage, and the unique requirements of each regulatory agency, this is a huge burden for companies in terms of both direct and indirect costs.
RIMS aim to help transform the way healthcare and life sciences organizations approach regulatory compliance. EXTEDO eSUBmanager, for example, is a market-leading pharmaceutical review software offering automation for regulatory data and submissions for authorization throughout the entire pharmaceutical product lifecycle.
How to bring your RIM software to the next level
But what if this process could be optimized even further? Collating the required documents, records, and data from various content systems and in various file formats to prepare submissions for authorization is a tedious task, with the added challenge of protecting personally identifiable information (PII) and sensitive medical records and data.
Enhancing the healthcare document management system (DMS) with an advanced, high-speed document viewer helps accelerate the collection, organization, and monitoring of information for regulatory submissions, all while ensuring the security of sensitive information.
A unique content viewing experience
With global experiences across multiple industries and a next-generation healthcare technology focus, ARender helps deliver further innovation to healthcare document management systems (DMS) by providing a fully-integrated, web-based content viewing technology.
During the medical and pharmaceutical review processes, knowledge workers need fast access to sensitive documents. ARender provides lightning-fast access to even the most high-volume files — significantly reducing the time spent opening and accessing documents. Once the document is open, users can securely view, annotate, and collaborate to streamline review and approval workflows during the submission process.
ARender partners with industry leaders like Extedo to help provide the most complete information management solutions on the market for healthcare and life sciences, enhanced with a secure document viewer that sits on top of the RIM solution.
The web-based document viewer has become an integral part of the Extedo regulatory software, with competitive features including:
- Viewing of large documents (up to 100,000 pages) in milliseconds
- Automated redaction of sensitive information and PII to meet privacy requirements
- Annotations features that meet XFDF norms for compliant collaboration
- User rights management and encryption available directly within the document
Customized offerings to help you scale
Global regulatory compliance for healthcare and life sciences has changed rapidly in recent years, with no loss of momentum expected anytime soon. This increase in regulatory complexity has increased the demand for innovative, cloud-based solutions that can effectively manage and automate these regulation processes.
Embedding web-based content viewing technology within these regulatory information management solutions helps create a more complete offering for healthcare organizations, with greater flexibility and improved user experience for all stakeholders.