Regulatory Information Management System (RIMS)
Regulatory Information Management System, or RIMS, provides organizations with a means to collaborate, maintain applications information data from multiple sites, improve Submission planning processes, and streamline the Publishing and Tracking of all regulatory activities that supports the entire life cycle of a product.
Regulatory Information activities in an organization start from the design of a drug to drug registration processes, to launching the product in market place. It requires multiple departments in an organization to collect the regulatory data information crucial to oversee all the steps in creating, registering and launching the drug. This data comprises of the design profile, concepts, technical information or specification as well as prototypes (if any). At this time, many organizations maintain and manage these activities with the help of spreadsheets and paper records.
Global regulations and data standards in the GMP Environments undergo a lot of changes very frequently. This reduces the efficiency of Regulatory Information Management when it is done using manual processes. It has become a challenge for the pharmaceutical, lifesciences and other related companies etc. The regulatory standards require organizations to adopt new technologies to plan for future requirements where all the documentation should be submitted through am electronic document management system
AmpleLogic Regulatory Information Tracker is developed on LOW CODE PLATFORM, It have 2 modules. ANDA Tracker and DMF Tracker.
Key features of AmpleLogic Regulatory Information Management Solution (RIMS)
- Submission Planning
- Submission Publishing and Tracking
- Submission reviewing
- Content Submission
- Tracking of Approvals/rejection
- Auto Alerts on FDA Goal dates and Other Target dates
- Product Registration
- Identify the product registration details
Benefits of Regulatory Information Management and Tracking Software
- Streamlines the submission process
- Improves collaboration & Accuracy
- Ensures compliance risks
- Eliminates wastages
- Reduces costs
- Increases efficiency
- Centralized Data base can be accessed from anywhere, regardless of location
AmpleLogic RIMS Software is designed in a way to automate the process, integrate with any existing or legacy system and increases the collaboration between department teams in an organization.
Regulatory Information Tracker also complies with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Other industries that can benefit from our Regulatory Filings Tracker
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages