RIMS Industry Perspective
An important industry trend is health authorities' changing regulations for data-oriented information exchange. Although paper-based processes have been largely phased out, data requirements have only become more sophisticated.
One example is the European Medicine Agency's Identification of Medicinal Products (IDMP) mandate, which introduces new stipulations on data elements and structures to uniquely identify medicinal products and substances. Organizations seeking to comply with IDMP must have established processes for data collection and evaluation. They may also need to perform remediation.
What is Regulatory Information Management (RIM)?
Regulatory Information Management is a set of processes used to collect, manage, and archive information in accordance with regulatory requirements. For life science companies, RIM can be a complex, time-intensive effort, but it is essential to ensure compliance and protect patients.
RIM comprises all information that is required by regulators to ensure safety, efficacy, and product quality. Examples include clinical trial information, safety data, manufacturing specifications, labeling information, marketing materials, regulatory submissions, and health authority correspondence.
Streamline Regulatory Data Management
Expedite the creation of new product registration applications and documents through a cloud-based repository that is available 24/7. Software can save critical time compared to paper-based methods or use of disparate systems. One centralized repository breaks down data siloes and permits strategy of re-using data across the company.
The Impact of Effective RIMS Software. Consider the following scenarios:
Leadership hopes to accelerate the product-to-market process.
RIMS enables regulatory process improvements that significantly sharpen your organization’s innovative edge and differentiation from...
Legal needs to reference a product specification that may be involved in litigation.
RIMS allows the system administrator to preserve the document as-is, ensuring no users are editing or deleting it.
Regulators mandate that new information is required to uniquely identify products.
A new metadata field is created in RIMS and made required for users. By the time that submissions are completed, you...
RIMS Software Vendors
There are numerous RIMS vendors in the life sciences space, all of which generally provide submission tracking, workflow automation, and document version control capabilities. We've listed three well-known solutions below:
- Documentum for Life Sciences (OpenText): Cloud-native platform that includes module specific to submission/correspondence storage and viewing. Accessible via web or mobile. Unique features include flexible upgrade timing and the ability to choose your preferred cloud infrastructure.
- EXTEDOpulse (EXTEDO): Comprehensive RIMS solution with five modules: Planning and Tracking, Document Management, Registration Management, Safety Management, and Submission Management.
- Veeva Vault RIM Suite (Veeva Systems): Cloud-based platform comprising four distinct applications: Submissions, Submissions Archive, Registrations, and Publishing. Vault Submissions has been adopted by 100+ organizations and is popular among enterprise companies.
News & Insights
December 19, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
December 17, 2024
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...
News & Insights
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
