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.
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