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

1. How QEdge assist you to accelerate your ROI
Sarjen 3/29/16

2. For more information please visit:
www.qedge.co.in
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 patient 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.
So these industries need to demonstrate that they are following common good
manufacturing practices and in their manufacturing process and also need to
ensure that compliance.
Having more than 10 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. Our comprehensive
package of solutions provide you the tools to manage various business processes
from batch recording in manufacturing to incident reporting and lab automation
for QC.
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
 Quality management system (QMS)
 Electronic batch recording system (EBRS)
 Document management system (DMS)
 Training management system (TMS)
 Laboratory information management system (LIMS)
 Regulatory information management system (RIMS)

3. For more information please visit:
www.qedge.co.in
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 process 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 creating user-defined customized reports and graphical outputs with
available fields of electronic forms
Electronic batch recording system
Qedge – EBRS module offers easy data entry, maintenance of batch information, data
security and integrity, and report generation. The batch information automation helps in
reducing noncompliance risks and increase in transparency.

4. For more information please visit:
www.qedge.co.in
Our efficient system offers optimization of various manufacturing resources including
equipment, manpower, processes and products. Electronic workflow management,
routings and notifications helps in achieving the operational efficiency within a shorter
span of time.
Key feature of our electronic batch recording system includes:-
 Covers entire cycle starting from MPCR preparation to approved BPCR archiving;
Template based design for faster implementation
 A web based application for processing, tracking, and managing different drug
manufacturing related processes
 Configurable workflow and easy data entry screens
 Videos and photos for operator instruction
 Auto-calculations
 Real-time tolerance checking
 Compliance flags indicating non-conforming data values
 Email alerts/notifications
 Dashboard with due and overdue batches
 Notifications for validation and stability batches while execution
 Interface with equipment’s, ERP, eQMS, eDMS, eTMS, LIMS, others
Document management system
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:

5. For more information please visit:
www.qedge.co.in
 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 – 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.

6. For more information please visit:
www.qedge.co.in
Key benefits of using our training management system includes:-that only the current
version the
 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
Laboratory information management system
Qedge - LIMS module offers a closed loop approach for sample tracking, task scheduling
and report generation in QC Laboratory. In comparison to the manual system of sample
tracking and data entry, this solution yields a greater process control by offering a better
management of standard specification and procedure along with generation of analytics
and reports. It also deliver the advantage of reduction in cost and time associated with
sample tracking, tasks scheduling and data gathering.
From study creation to sample logging to test scheduling, data entry and report
generation, our LIMS solution offering provide a flexible and easy to use solution that

7. For more information please visit:
www.qedge.co.in
 Ensure compliance in accordance with legal regulations.
 Full support and documented evidence for the validation performed by our
efficient team
 Management of the life cycle of the received sample from entry to disposition
 Pre-defined workflow and interactive user interface and ability for charting and
reporting
 Provision for automated calculations and specification checking
 E-signature and date-time audit trails as per 21 CFR Part 11
 Stability testing and inventory management
 Work creation for the performance of testing and its tracking
 Generation of reports like certificate of analysis and other miscellaneous reports
 In-built search engine for searching the available data across the system
 Easy tracking of pending actions and retrieval of data
Regulatory information management system
Qedge – RIMS module is a life cycle process of drug (starting to end), from which
organizations are effectively and efficiently developing and handling new and existing
products information before, during and after drug registration. Our RIMS solution helps
in improving the perfection and standard of Pharma regulatory information which ranges
from planning, tracking and managing all the regulatory activities, drug life cycle and
submission operation. It helps in improving overall speed and quality of regulatory
submissions. Its features includes:-
Maintaining an audit trail as per the 21 CFR Part 11 compliance and also complying with
regulatory submission standard
 Effectively manage the post submission query raised by regulatory authority
 Organize and trail regulatory events such as registration date, expiry date and other
reminders
 Facilitate the effective searching such as by country, by product, by registration
status
 Unique place for search, store and manage all regulatory documents
 Common processes for creating, organizing, sharing, archiving, authorizing,
reviewing, approving and managing complete documents with minimum efforts

8. For more information please visit:
www.qedge.co.in
 Effective dashboard for status of various tasks, progress, updates, effective
reminders for events and in-built conversation system