Every pharmaceutical product and medical device must follow complex regulatory requirements to ensure safety and efficacy. However, adhering to these requirements can be challenging as industry regulations change. Work with the experienced regulatory consultants at Daelight Solutions to keep your products, processes and systems compliant throughout the entire lifecycle.
Enhance your regulatory information management system (RIMS) with the help of Daelight Solutions. As experts in regulatory affairs, we understand how to get the most out of your RIMS to help streamline your processes. Rely on us for tailored solutions that optimize functionality:
Daelight specializes in guiding organizations through the process of selecting a new RIMS that aligns perfectly with their unique needs and regulatory requirements. Our experts will assess your current regulatory workflows, data management practices, compliance challenges and future growth objectives to understand your situation. Then, we’ll develop a list of RIMS options that make sense for your organization. Our team supports you through vendor evaluations, demonstrations and negotiations so you can make an informed decision.
Once you have selected your new RIMS, our team will support you to ensure the vendor configures the system to your unique needs. We can also provide documentation support for the following:
Building validation plan
Traceability matrix
Test scripts
Validation summary report
Support training
Whether you need to move data from one system to another or merge two systems, trust the team at Daelight for a smooth migration. With countless RIMS migrations under our belt, we have the experience and tools necessary to handle complex data migrations with precision and efficiency. Our proven methodology includes meticulous planning, data mapping, validation and testing to ensure seamless transition and data integrity throughout the migration process.
We also offer proprietary migration tools to enhance the overall process:
If you need help establishing a connection between your RIMS and other content management solutions (such as Clinical and Quality), laboratory information systems (LIMS) or other critical systems, choose Daelight to ensure a smooth and effective integration process. We collaborate closely with your IT and regulatory teams to understand the specific data exchange needs, regulatory compliance considerations, security protocols and business objectives. Let us provide support during and after the integration to ensure your data flows seamlessly between systems.
If you aren’t happy with the performance of your existing RIMS, we can help fine-tune it so you can achieve optimal results. We’ll conduct a thorough assessment of your current RIMS setup, identify areas of improvement and document everything in our report. Utilizing the assessment report, you can implement the changes yourself or our team can support these changes following your business processes.
Do you have a Veeva Vault RIM? Maximize your investment with our custom Health Check. This system and process review allows us to evaluate your business needs and ensure your RIM is performing at optimal levels.
Getting More Value from Your RIM Investment
New regulations, like the Identification of Medicinal Products (IDMP), impact how you manage your data. But without an expert explaining the effects, it’s difficult to navigate these rules. Partner with Daelight Solutions to fully understand current and new regulatory guidelines so you can stay on top of your data.
Technology-based interactions between life sciences firms, external partners and regulatory agencies have created tremendous opportunities to eliminate manual processes and speed up overall submission timelines. Unfortunately, they’re also fraught with the possibility of mistakes and inefficiency. Daelight can help with the following regulatory information management applications:
Registrations
Submissions
Submissions publishing
Submissions archiving
Registering your new product with the appropriate organizations is easier with Daelight. Leveraging advanced technology and deep regulatory expertise, we centralize and streamline registration data across multiple jurisdictions.
Optimize your information gathering, organization and submission activities with the help of Daelight. Our proven methodologies and experienced consultants have helped organizations large and small:
Move away from paper-based submissions in accordance with established best practices
Ensure the accuracy, completeness and organization of essential data
Integrate systems of record with RIM and Publishing solutions
Stay up to date (and in compliance) with the latest health authority guidance on electronic submissions
Standardize conventions and eliminate duplicate data
Eliminate error-prone manual processes by automating workflows
Streamline quality control and audit efforts
The Daelight team has proven abilities to guide projects from concept to conclusion. Our experienced team not only offers technical expertise in solutions designed to optimize RIM functions but also has a firm grasp on the business processes that they support.
We’ve worked with all leading registration, submission content management, publishing, archiving and registration solutions, including:
As Veeva and Generis partners, we have the knowledge and experience to optimize your Veeva Vault RIM and Generis CARA systems. We can also help you seamlessly migrate to these systems for efficient and effective regulatory operations.
Daelight is a system-agnostic regulatory consultant, allowing us to work with all RIM solutions. If you need a new RIMS, rely on us to recommend the best system for you and your needs.
When you need tailored solutions and strategic guidance to help your organization navigate regulatory complexities, achieve compliance, and drive business growth, choose Daelight. Discuss your needs with one of our experts today.
A regulatory information management system (RIMS) is designed to streamline and manage regulatory processes and information within the life sciences industry. RIMS helps organizations track regulatory submissions, manage compliance with global regulatory requirements, maintain product registration information and handle communication with regulatory agencies. It centralizes all regulatory data, documents and activities and provides tools for planning, tracking and reporting regulatory submissions and interactions.
Veeva Vault RIM is a cloud-based regulatory information management system offered by Veeva Systems. It ensures compliance with global regulatory requirements, enhances collaboration across regulatory teams, and improves the efficiency and transparency of regulatory activities. Veeva Vault RIM integrates with other Veeva Vault applications to facilitate seamless data flow and support end-to-end regulatory management.
OpenText Documentum for Research and Development is a specialized solution within the OpenText Documentum platform, tailored specifically for the life sciences industry. It’s designed to manage and control documents and data throughout the research and development (R&D) lifecycle of pharmaceutical, biotechnology and medical device companies.
Generis CARA is a comprehensive content and information management platform designed to help life sciences organizations efficiently manage, process and utilize their information. The unified CARA Platform is built with powerful functionality to ensure security and compliance across critical business processes.
The Identification of Medicinal Products (IDMP) is a set of standards developed by the International Organization for Standardization (ISO) for identifying and describing medicinal products. These standards aim to improve the consistency and accuracy of information on medicinal products across regulatory agencies and the pharmaceutical industry worldwide. IDMP covers various aspects, including the unique identification of medicinal products, substances, pharmaceutical product information and marketing authorization information.
