How QEdge assist you to accelerate your ROI

The Pharmaceutical, Life Science, Healthcare and Clinical research organizations (CRO) all require to face the complex task of meeting all FDA regulatory compliance requirements including 21 CFR part 11 and other ISO compliance standard and various regulatory authorities of various countries. From discovery to clinical trials to final delivery of product to the patients, need assurance of quality, safety and efficacy. Cost incurred in getting FDA consent is huge so delay in final delivery of product means lost revenue. QEdge assists here.

So these industries need to demonstrate that they are following common good
manufacturing practices to achieve smooth compliance.

Having more than 25 years of expertise of developing regulatory solutions for top
multinational Pharmaceutical companies and CRO’s, Sarjen Systems has developed
an end to end solution dedicatedly for Pharmaceuticals, Life Science and CRO’s to
meet stringent regulatory requirements, called QEdge.

QEdge provide you a single unified platform to streamline and automate your
process, people, procedure and documentation for better transparency, control
and performance.

Salient features of QEdge

QEdge Quality management system

QEdge – QMS module offers a proven platform for management of various quality processes that includes CRF, deviation, investigation, CAPA, OOS, OOT and audit management. The fully configurable and intuitive suite helps in maintaining key user requirements along with requisite regulatory provisions. QEdge offers a robust centralized respiratory for management of all the quality processes with a better control and information sharing among the functional users:-

Improvement in regulatory compliance – through audit trail, data integrity, electronic signatures, electronic records i.e. allows data flow between stages on a real-time basis along with capturing of electronic signature
Robust configuration tools fulfill workflow designing as per each organization’s need
Provision of alerts and notifications to “responsible” profile on routing of tasks
Better control on QMS through effective interlinking of key processes like Deviation/Complaint with Investigation and CAPA
QEdge offers Parent-Child concept for effective communications and data gathering; also offers role based child initiation for better process control
Provision for cross functional involvement for inclusion of other profiles in QMS processes that are not the part of defined workflow; acts as a bridge for connecting other departments with QMS processes
Ability of creating user-defined customized reports and graphical outputs with available fields of electronic forms

Document management system - QEdge

QEdge – DMS module offer SOP management, controlled copy release and many more within a single platform. SOP’s, annexures and other relevant documents are used in regulated environment to ensure completion and control of various critical processes and procedures. A regulated environment and various associated department use various documents and SOP for performing important tasks and hence such documents play a crucial factors during inspection and audits by regulatory agencies.

QEdge- DMS module help to track and manage organizations’ SOP’s and other relevant documents in the most effective way by providing an efficient tool for SOP management and controlled copy release. The salient features of our document management system includes:

Covers the entire life cycle of SOP/ other relevant documents with predefined workflow that includes creation, review, approval, version control and distribution
Offers a centralized storage to all company information for a real time analysis and access
Track document versioning, collects e-signature and send reminders for pending assignments
Easy integration of training with document control process; storage of all the SOP information that can be simply, quickly and securely accesses by the authorized person
Easy mitigation of risks and improvement in productivity
Auto alerts and notification to the concerned employee for review/ approval/ publishing of SOP’s
Provides automatic revision control to ensure that only current version of document is available
Integrated solution that connects quality sub systems like CAPA, change control etc.
Set periodic review dates for time reduction and effective document management cycle
Report generation for assignments, document history, quiz results, document collections, employee groups

Training management system - QEdge

QEdge – TMS module offers a unique cost effective package for identification of training needs as well as a centralized storage to manage all the training metrics for a real time analysis and access. Designed by keeping in mind the specific requirements for a regulated environment, QEdge Training Management System automates the training operation to enhance productivity and improve overall compliance. It can be easily integrated with SOP Management and other QMS processes.

Key benefits of using our training management system includes:-

Identify Training needs and Training gaps, Easy tracking/scheduling and various MIS reports to enhance transparency and accountability
Effective tracking of training from scheduling to completion
Online access to employee’s training performance metrics
On demand access to courses, videos, various document types
Easy reporting of training schedules, reschedule, assignments and scores, retraining
Generation of assessment reports for the trainees
Attendance tracking for employee participation
Creation of training template, storage of interim work
Automate manual workflow with inclusion of multiple departments with defined responsibility at each stage
Improvement in regulatory control and better results for compliance initiatives and audits

About QEdge

QEdge is a holistic Enterprise Quality Management System that helps automate quality processes. Know more about EQMS here. When it comes to quality processes, a 360-degree approach to managing quality at an enterprise level is very important. Choosing a vendor who can understand your business well and help you experience a seamless digital transformation for quality processes, is a challenge these days. Here are 5 factors that you can consider while choosing the right vendor for your EQMS.