Introduction of RIMS
Regulatory information management (RIMS) is an important organizational activity; starting from document management to product registration, with post registration and maintaining all the relevant information along with various timelines for various countries.
Not an easy task! And it would be more difficult if companies use MS Excel – a very common practice using a flat, single dimensional application where people have to be on their toes rather than MS Excel helping ease their workload!
Why RIMS?
ProcEdge RIMS, the RIMS software solution, is a centralized, platform that help manage global regulatory information across companies’ entire portfolio of products.
It lets users maintain accurate product pre- and post- approval product data and helping them easily manage, track and maintain product license/submission/correspondence, in short, 360° information (helps in tracking of product registration and post registration activities). The information or change in information would be available across departments in real-time reducing chances of errors.
ProcEdge RIMS connects all departments with the use of storage of important information on a single platform. Thus, with ProcEdge RIMS companies gain improved visibility across all departments, also, get a global view of issues in turn enabling faster, informed decision-making at much lower costs.
ProcEdge RIMS helps companies to ease the pressure to reduce the costs of regulatory operations and speed up health agency approval to accelerate time to market.
Day-to-day challenges for companies…
Companies must keep in line with…
- Requirements of the regulatory agencies being dissimilar from market to market
- Keeping track of multiple product in multiple countries
- Product variations and renewals, which is extremely difficult in excel
- Maintaining disconnect of product information which comes from different departments
- Distributing central product information to all related departments
- Meeting different timelines for various countries
Simplified approach to address challenges…
A chance to avail centralized platform for trouble-free operations in overall management, 360° product information. Which…
- Helps regulatory professionals meet and maintain compliance standards for their global product portfolio
- Supports industry standards which are imminent such as IDMP
- Includes solution for Product registration, planning and tracking of entire product life cycle
- Allows robust handling of data
- Helps track all the timeline (timeline for varying procedures for various products for various countries)
Features
Benefits
- Product submission processes and data management, eliminating risk of non-compliance
- Track submissions within timelines, also, Reminders for regulatory events
- Detailed submission planning for each country specific regulations with improved submission effectiveness
- Effectively manage post submission query/s raised by regulatory authorities, eliminating delays because of queries and their responses
- Effectually organize and track regulatory events (registration date, expiry date)
- Increase speed and quality of regulatory submissions
- Track status of commitments and correspondence required to keep products on the market
- Leverage electronic notifications to alert users of critical information updates
- Eliminate spreadsheets, tedious and error-prone manual data entry and linking
- Improve data control and consistency
- Reduce all round operational costs by eliminating redundant systems
- Get easy access to all regulatory relevant product data
Features
- Configurable data model as a single platform
- Robust workflow engine
- Automated email notifications, tracking and trending dashboard of key information
- Query management – assigning and forwarding to setting timeline for response to sending response to regulatory authorities to collating queries for each product to keep in mind for next submission
- In line with IDMP standards
- GxP compliant system – ProcEdge RIMS is a closed system, where users assigned role-based access and operational rights, and electronic records electronically signed, with audit trails
- GDPR and Part 11 (21 CFR and EU Annex 11) compliant
- Following structured approach, which…
- Ensures software reliability
- Ensures software effectiveness
- Ensures software regulatory compliance