1.
The Advantages of a Cloud Based
eQMS over Paper Based QMS
Systems

2.
A quality management
system (QMS) is a set
of interrelated or
interacting elements
of an organization to
establish policies and
objectives, and
processes to achieve
those objectives.
QMS: Definition and Quality
Principles
1

3.
 supports business leadership
 promotes customer focus
 improves company culture and
the bottom line
 manages new innovations
 helps the company understand
any issues
Benefits of a Quality Management
System
2

4.
ISO 9001:2015
What Guidance Is
There for Quality
Management
Systems?
• international standard for quality management systems
• uses a high-level structure (known as Annex SL)
• the Plan-Do-Check-Act (PDCA) approach by W. Edwards Deming
• continuous improvement
• risk-based thinking
3

5.
A QMS helps coordinate and
direct an organization’s
activities to meet customer
and regulatory requirements
and improve its
effectiveness and efficiency
on a continuous basis.
Types of Quality Management
Systems
4

6.
Smooth Drug Development
has a self-developed
Clinical Trial Management
System (CTMS) which
consists of several
modules
∞ CTMS modules can be used together or separately
∞ CTMS can be used by third parties (Sponsor and Vendors)
∞ Additional customization is possible — can be configured to meet
individual customer processes
∞ Multilingual system
∞ Web-based, no installation needed 21
∞ CFR Part 11 compliant
∞ Audit trail and access control Uses
∞ “Go-to-Green” technology
LEARNING / HUMAN eTMF / eISF CLINICAL PROJECT ePRO EDC / eSOURCE /
QUALITY RESOURCE MONITORING MANAGEMENT IWRS
MANAGEMENT MANAGEMENT
SYSTEM
Clinical Trial Management System
(CTMS)
5

7.
All in One Place
6
vs
.

8.
One system instead of dozens
Neat data structure
Easy additional customization of the system
Access to the system at any time, from any place
The system is multilingual
Accessible to
Everyone
7

9.
CTMS is based on the Go-to-Green technology – color driven user interface helping users to better understand what actions are
required in the system.
On the example below one of the documents is approaching to the Expiry Date and this is shown at the top level and in the menu.
«Go-to-Green» Technology
8

10.
 Access to all documents at any time, from any
place
 Access to all documents and their last version
or status
 All documents are easily accessible via internet
 No possibility for unauthorized access to QMS
 No possibility to lose documents
 Decreased margin of errors
 Documents expiration control and alerts
 High level of security
 Remote audit readiness
Efficient QMS Documents
Management
9

11.
Tracking Progress
10

12.
Better Training
11
• Learning / Quality Management System Module is used to create, assign,
assess, track, monitor and report, trainings seamlessly:
 To develop assignment matrix and acknowledgement status
 To upload trainings in different format including ppt and video trainings
 To assign trainings to employees
 To perform a self-training proven by an electronic signature
 To get access to training documents at any time, from any place
 To remind employees about trainings via e-mails and color alerts in the
system
 To perform knowledge testing via test. Trainer can assign the questions
(evaluation) and answers and the passing score for the training
 To perform retraining
 To provide training log
 To inform line managers about non completion of the training
 To track all training activities
 To get access to trainings logs
 To oversight trainings

13.
Easy CAPA
Management
12
The QMS module of CTMS can:
∞ assign CAPA-related tasks to the team
∞ remind about pending actions
∞ track progress through to completion
Adding audit participants
Responsible personnel enter route cause
Responsible personnel indicate CAPA and their planned and completion dates
If applicable – confirmation documents for QA check are uploaded
QA can add comments to CAPA and route cause until all the issues are resolved

14.
Efficient Communication
13
• Human Resource Management Module is used for management of
employee’s personal folder (CVs, diplomas, certificates, trainings, job
permit, etc.).
• The module enables:
 Documents upload
 Review of employee’s folder by QA
 Auto check of documents
 Auto notifications to employees and their managers about personal
folder completion, update, expiration
 Document expiry date control
• Clinical Monitoring Module is a module for management
of monitoring visits, monitoring tasks and site deviations
• The module enables:
 to track CRAs visits and CRAs workload (days on site)
 monitoring report review and approval by the Line
Manager and QA

15.
Effective Vendor Management
14

16.
Conclusions
15
• eQMS helps to:
 Use one system instead of dozens to manage
your quality processes
 Improve communication and collaboration
within your quality department
 Automate and streamline your QMS processes,
to improve efficiency, and reduce costs
 To improve compliance with regulations and
standards
 Better understand and assess your quality data
 To accommodate your company’s growth

17.
info@smoothdd.com
bd@smoothdd.com
www.smoothdd.com
USA
2711 Centerville Road, Suite 400,
Wilmington, DE, USA, 19808
+1 302 660 06 14
Europe
Tartu mnt 6, Tallinn,
Estonia, 10145
+37 266 67 475
Contacts