Introduction to Sarjen’s eCSV solution
eCSV is a documented process for assuring that a computer system serves the designing purpose. As the pharmaceutical and life sciences industries continue to modernize and implement more technology, there is an increasing need to be sure these technologies are safe and accurate for end users. eCSV becomes important as the US FDA requires all computerized systems with GxP electronic records to be validated. The life sciences industry is proactive in validating systems in compliance with part 11 (21 CFR Part 11 & Annex 11), which means the ability to generate accurate and protected records and time-stamped audit trails.
eCSV is all about managing of e-signature sequence of involved users with the whole cycle of document. It handles the electronic record keeping of any Regulatory or Non-Regulatory document processes. It can be Deployed/Configured at On-Premise server or on Cloud server.
Electronic Document Signing Solution for all business domains
eCSV manages the electronic process of documents that involved in Review & Approval cycle. Maintaining signature and task hierarchy, where signature details get automatically embedded in each document.
In eCSV, we can also upload legacy documents that are already processed for record keeping. These projects are considered as archived projects. eCSV provides audit trails as per required regulatory compliance.
Manual processes are not reliable as it takes lot of resources, time, and efforts into its background. The process of document cycle, e.g. creation, review, approve and then respective signing becomes complex as it is a long-drawn, laborious and prone to errors. Specifically, an area practically pleading for automation of the process.
To lessen all such troubles, Sarjen’s eCSV solution offers electronic document signing which eases, manages and tracks signatures of all involved in that project which then can be used to provide key analytics.
It goes beyond the basic regulatory requirements as it complies with US FDA 21 CFR part 11, EU Annex 11 and GAMP 5 guidelines and regulations.
- Easy monitoring and Status updates
- Evidence of Signing Execution
- Quick setup of roles and responsibilites
- Safe document distribution
- Controlled process
- Secure record retention
- Enhanced productivity
- Collaborative task and transparency amongst team
- On-Premise or Cloud-based implementation options
Features & Benefits
- User friendly and easy to use
- Easy to create/reuse document templates
- Easy access of pending task from dashboard
- Reports for quick monitoring document current status
- Controlled document approval life cycle within just a few clicks
- Easy signature capture of documentation
- Pre-defined various MIS reports for realtime status
- Email alerts for notification
- Regulatory compliance; 21 CFR part 11, EU Annex 11 and documentation as per GAMP5
- Upload archive CSV documents to create one document repository
- Streamlined approval cycle of documentation, improving all round transparency
- Leads to better control for various simultaneous projects
- Gain rewards of saved time, smoother processes, reduced paper costs and its physical long-term storage
- Having finger on the pulse of status of every project
- Improved Quality compliance; being consistent, timely, accurate and secure
- All documentation under single roof using archived documents feature
Get in touch with us
6th Floor, Arista, Anandnagar road, Ahmedabad 380015, India