Harmony’s Regulatory Intelligence is a regulatory compliance software that offers powerful solution and innovative approach for control of pharmaceutical regulatory affairs. Core capabilities of regulatory compliance software includes tracking and submission management, as well as integration with the document management system. Flexibility to adapt to change is the primary ingredient that makes Harmony the tool of success for your company.
REGULATORY COMPLIANCE SOFTWARE
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HARMONIZED GLOBAL REGULATORY DATABASE
- For Effective Regulatory Work Planning -
Harmony offers a secure global repository for all your regulatory data. This gives you complete control over your team’s activities, local or remote. Manage all product registrations, renewals, queries, deficiencies, post-approval variances along with key regulatory compliance documents from one place.
Our Regulatory Intelligence Modules
- Manage Product data & Registrations
- Renewals notifications / alerts
- Centralized document repository
- Integration with eCTD and ERP systems
- Submission templates by market
- Submission forecasting & management
- Status Reports and Analytics
- Secure access to all regulatory teams
- Linked to product registrations
- Manage HA interactions
- Track all types of queries and deficiencies
- Action item planning and tracking
- Knowledge management
- Escalation management for timely response
- Status Reports and Analytics
- Secure access to all regulatory teams
- Linked to product registrations
- Manage post-approval variations
- Manage annual submissions
- Track submission timelines
- Reminders at pre-set intervals
- Knowledge management
- Status Reports and Analytics
- Secure access to all regulatory teams
Features of REGULATORY COMPLIANCE SOFTWARE
Secure Access
Securely manage access based on role, department or facility to various modules. Access can further be restricted by login device, local time & location.
Perspective Impact
Detailed analysis of all affected linked filings (for e.g. shared packs, dependent artworks
Always on Track
Respond to your queries on time, and meet all of the annual mandatory filing deadlines without fail
Benefits of REGULATORY COMPLIANCE SOFTWARE
Achieve zero deficiency filing objectives using advanced data mining options
Achieve Zero Deficiency Filing
Learn from the past, making your filing processes error-free for faster approvals
Intregrate QBD Into Your Routine
With reduced rework, incorporate a right-first-time culture
Decentralized - Yet Controlled
Local regulatory teams continue to work the same way, all in a central system
Learn how process automation will bring time and revenue benefits. Take the first step now
WHAT PEOPLE SAY
Greatfour support is responding in time to move things faster.
Harmony's Proofing System Pixel to Pixel comparison & Text to Text comparison provides an excellent comparison for small – small things. The system is fulfilling 100 % CFR requirements and additionally providing individual projects summary.
‘Harmony’s Labeling & Artwork Management software has been a very effective software for our organization in managing Artworks. Some of the remarkable features of it are simple but very informative Dashboard, parallel & sequential workflow, traceability & Audit trail of Artworks, comparison of two Artworks (GPR Tool) and two ways integration with SAP. The software is also very Robust in use. Also, its support team is always prompt in providing solution especially in case of urgency.’
Harmony's Labeling & Artwork Management is a good online artwork management tool designed keeping the pharma artwork workflow and day wise hiccups we face to deliver the artworks in a quick turnaround time and at the same time maintaining the overall activities in compliance state.
As its web-based software and having provision to store entire projects (carton, label, Leaflet details) data in one place which helps to review & complete the task immediately. It manages the complete labeling process in a defined manner and automates the workflow, saving time, managing accountability of work, and providing visibility of completed work. Checklist popup provides alertness to individual end –user and reduces mistakes.
Harmony acted as a good artwork library hence we saved a good amount of physical storage space which was otherwise wasted behind saving hard copies. Artwork workflow of individual packing materials with the time taken is documented and preserved. We need not follow up for the artwork approvals which saved a considerate amount of time.
Harmony’s Labeling & Artwork Management and Proofing software is a evidence to have efficient artwork process, better lead time in reviewing and approving artwork, review comments availability with annotations, better tracking of revision with audit trials, easy report generation with respect to Artwork process, reduce repetition work on artwork process, configured as per our requirement, better text management, minimize errors and mitigates regulatory/ compliance risks, integrated with existing infrastructure (ex: SAP) & reduction of man working hour.
GreatFour's application is user-friendly. One can easily understand it especially the workflow and its dashboard which play a vital role in the user’s support. GreatFour's support team is excellent. It is like a client's IT fire brigade in case of emergency.
‘Harmony has provided a platform to consolidate all the artwork information like specification, Master packing dossier, Analytical test report, Print Proof comparison & Shade card into a single controlled system that everyone can use and helped us to have better visibility on the artwork management process’
Harmony’s Labeling & Artwork Management - an online artwork approval software solutions have helped to manage several critical operations. ‘Labeling & Artwork Management’ can also be extended to additional areas such as training management and other critical process areas that can affect the business.