Overview
The Risk-Based Inspection (RBI) Tool enables regulatory authorities to plan, conduct, and manage inspections of pharmaceutical manufacturers and distribution facilities. It supports enforcement of GMP and GSDP compliance, authorization decisions, and monitoring of medical product quality throughout the supply chain to protect public health.
Systematic Features Includes Following:
Backup Facility
Software will provide the feature to take data backup as well as the application backup that may be used for Disaster and Recovery event.
Audit Log
Whenever there is a requirement to see who did what and at what time, from where, etc., Audit Log is the right place to look into this.
Basic Reports
There are pre-defined reports in the system that are default reports used as basic reports. System, however allows user to create more and user-defined reports as needed.
System Enable/Disable
Whenever there is a requirement for the system /software maintenance, this option can be used by the admin and during this maintenance time, no one can access the system.
Company Logo
To brand your software, system will allow user to upload your company logo that will be used in the system interfaces and on the reports as well.
Data Protection
As per CFR-21 recommendations, the data will be saved in the database in an encrypted format where even admin user can't understand it for any possible data manuplation or forgery. Only an authorized user can access from the user interface. All data modification actions are recorded as audit-log trails.
Password Policy
As per international best practices on security standards, we have included password reset option, minimum password length, allowed characters for the password, User must change the password after a specified period, 2-Factor authentication to login to the system and CAPTCHA code integration.
Logical Features Includes Following:
List Page Filtration
This option can be used in the data table lookup to narrow down your desired output. Similar to Excel, you can filter various columns data by providing the keywords against each column.
Email Notification
System will generate various types of emails on different triggering points that will be used throughout the workflow of a process.
Custom Logic
Custom logic of the business application can be designed and implemented inside the application in a very short time.
Custom Reports
Beside the default reports, user can create his /her own custom reports as needed by the business objectives and requirements.
Admin Features Includes Following:
User Management
User Management is a system where admin of the software can create new users and can assign respective defined roles to the users who can use software as desired.
Alert Management
Alerts can also be defined as broadcast, department-wise, designation-wise or even specific user-wise that can be triggered at specific time.
User Registration
This feature is like Signup feature for the new users who wants to be part of the system. User will fill-in the form and will send request to admin who will accept or reject the signup request.
Customization Features Includes Following:
Profile Management
After successful login, user can update his /her profile and can also change his /her password. Beside this, user can also change the profile picture as well.
Background Wallpaper
As per user preference, user can set wallpaper of his /her choice. User can select the wall paper from the pre-defined list of wallpapers.
Custom Fields
There are some fields which are related only to user's business, if required, it can be added up for various activities.
Import Excel Data
If user has already data available in some excel format, here user can download the data template and can upload the required bulk-data in one-go.
Export Data To Excel
From the data lookup tables, user can download data in various format, like PDF, Excel or CSV. User can also copy the data and can also print directly on the connected printer.
API Management
System is capable enough to be integrated with any other system. For the integration perspective, various datapoints related APIs are exposed and can be used as desired.
Custom Dashboard
Every user role has his /her own dashboard. Dashboard can also be customised as per user needs and requirements.
Modules
GMP
The GMP module supports inspections of pharmaceutical manufacturing facilities by providing administrative functions such as managing manufacturers, inspection pools, and inspection scheduling. It also supports inspectors with inspection preparation, selection of applicable systems and elements, execution of inspections, system-generated inspection reports, dashboards, CAPA generation, CAPA follow-up, and regulatory reporting.
GSDP
The GSDP module focuses on inspection of storage and distribution facilities and includes administrative functions for managing facilities, inspection pools, and inspection schedules. Inspector functions include inspection preparation, execution, system-driven reporting, dashboard monitoring, CAPA generation, follow-up activities, and reporting.
Mobile App for Offline Inspection
This module allows inspectors to conduct inspections using a mobile application without internet connectivity. Inspection data is captured offline and synchronized with the central system once connectivity is restored.