Need for this  

Manual data entry increases the risk of errors and inconsistencies, leading to delays and potential compliance issues. 

Preparing and managing application forms manually takes significant effort, slowing down regulatory workflows. 

Users need a way to extract data into Excel as per RIMS fields for easy review, but manual extraction can be time-consuming and error prone. 

Regulatory submissions require structured and standardized data to comply with global regulations like EMA and FDA, making manual processes inefficient. 

How it benefits  

Ensures Compliance: Keeps submissions aligned with global regulatory standards like EMA and FDA, reducing compliance risks. 

Minimizes Errors: Automates data validation, reducing manual mistakes and ensuring accuracy in regulatory submissions 

Simplifies Data Extraction: Allows data to be extracted into Excel as per RIMS fields, making it easier for users to review and analyze. 

Improves Review Efficiency: Provides a structured format that simplifies document review, making it easier to check and finalize submissions 

Speeds Up Submission Process: Automates form filling and tracking, reducing time spent on manual entry and submission preparation. 

How we are using this in our product  

eAF in our RIMS helps automate data entry and validation, reducing manual errors and ensuring submissions follow regulatory standards like EMA and FDA. It allows data to be extracted into Excel as per RIMS fields, making it easy for users to review and update information. By automating form creation and tracking, it speeds up the submission process and helps regulatory team’s complete approvals faster. With a well-organized format and version control, eAF simplifies document review and improves audit readiness. 

Result of implementation  

Adding eAF to our RIMS product has made regulatory processes faster and easier by automating data entry, checking, and tracking. It reduces manual work, improves efficiency, and ensures accurate, compliant submissions. Users can easily pull data into Excel from RIMS fields, making reviews and decisions quicker.