QAD Quality Management Systems Roll Out
November 17, 2014
Outline
 Vitatech Company Overview
 Quality Department Functionality Requirements
 QAD-QMS System Overview
 Vitatech QAD-QMS Integration Design
 Project Plan Implementation Timetable
 Examples of Electronic Signature & Reporting
2
VITATECH Nutritional Sciences Overview
 A leader in the nutritional
supplement manufacturing
industry
 Sixty years-FDA licensed
contract manufacturer of
dietary powders, tablets & two
piece capsules
 A Tradition of Excellence ™
 Custom nutritional solutions
− Make to Order & Make to Stock
− Fulfillment to mass market
distribution centers
 State of the art technology
QAD Upgrade History Time Line
Initial Go Live
•
•
•
•
•
•
55 Users
Desktop UI
Core
Product
Enhanced
Controls
Radley
Data
Collection
Cyberquery
Upgrade to
.Net
•
•
•
•
•
•
65 Users
New .Net UI
Core
Product
Enhanced
Controls
Radley
Data
Collection
Cyberquery
Upgrade to EE
•
•
•
•
•
•
75 Users
Core
Product
Enhanced
Controls
Radley
Data
Collection
Cyberquery
EDI
Upgrade to
Quality
Module
•
•
•
•
•
•
Implement QAD
QMS System
•
•
100 Users
Core
Product
Enhanced
Controls
•
Radley
Data
•
Collection
•
Cyberquery
EDI
50 QMS Users
APQP
(Device/
Batch
Master)
Inspection &
SPC
CAPA & NCR
Integration
Overview of QAD Users by Functional Area
Purchasing; 4
Data Control; 3
Document Control; 8
Quality, 31
IT/System; 4
Accounting/Admin,
5
R&D; 5
Open; 2
Sales; 6
Shipping/Receiving;
10
Operations; 7
Planning; 7
Weighing; 7
Quality Department Principles
 Ensure Vitatech maintains our FDA pharmaceutical license and
makes certain that the company is in compliance with all
cGMP requirements.
 To facilitate and enable the use of quality standards to
motivate continuous improvement in process capabilities.
 To maintain all current industry certifications.
 To develop and maintain quality management systems that
operate efficiently and effectively in processing quality orders
and quality reporting in all areas.
6
Vitatech Critical Quality Department Needs
 Quality Master Data
− Electronic Signatures
− Attachment capability
− Master file templates
 Quality Inspection
−
−
−
−
System generated test results
Electronic approval & routing
Data Analysis including trending of test results
Mobile Device Data Entry
 Electronic Certificates of Analysis
 Implement a CAPA/NCR program
7
High Level Quality Management System Overview
APQP
(Device/Batch
Master)
Go Live
Module
CAPA &
NCR
Inspections &
SPC
Audit
Management
QAD ERP
System
Powerful
Integration
QAD QMS
Supplier
Management
Training
Management
Document
Control
Calibration
8
Module Descriptions
 APQP (Device /
••••Process
Audit
CAPA
Controlled
Gauge
Approved
Quality
Skill Management
Questions
(Corrective
Flow
Tracking
Order
Supplier
/ &
Batch Master)
Checklists
Preventive
Documents
List
Tracking
Actions)
••(Routing)
Gauge
TrainingCalibration
Tracking
 Audit Mgmt
••••Process
Internal
NCR
Engineering
Schedule
Supplier
Inspection
(NonFMEA
Audit
/ Event
History
Employee
 CAPA & NCR
Schedule
conformance)
Changes
Performance
and
Results
Analysis)
•(Hazard
MSA
Certifications
(Measurement
 Document Mgmt
Reviews
•• •Process
LPA
Quality
Records
System
SPC
(Layered
(Statistical
Alerts
Analysis)
Plan
Links
toControl
Documents
 Calibrations (Gauge ••(Inspection
Process
study
Supplier
Process
tracking
Audits)
Control)
Audits
plan)
RMA
Manuals
module
(Returned
Tracking)
Charts
• PPAP
Other
Material
(Production
Audits for
 Inspection / SPC
•Part
example
Authorizations)
Trigger
Approval
Events
Safetybased
 Supplier Mgmt
on Rules (WECO)
• Process)
Analysis
 Training Mgmt
• Work Instructions
9
Configuration
 Add/Remove fields
− Fields can be added
or removed to support
the requirements of
configured processes.
 Workflow
 EOB Templates
−Best practices which can
be easily modified to
meet your business needs.
− Workflows of
processes are secure
and easily modified to
automate and
facilitate the
completion of
business processes.
10
Reporting
 Powerful
− Reports can contain data
from multiple processes
displaying charts, pictures
as well as analysis data.
 Crosstab
− Easily review data
 Built In
− Easy onboading
processes contain built
in reports.
organized by common
groups such as months,
quarters or departments.
 User defined
− Available report designer,
allows for user defined
reports available directly
from the user interface.
11
Action Manager
 E-mail
− Clicking hyperlinks
embedded within the email
opens the application to
the exact place where the
work gets completed
 To Do List
− All actions are available for
 Automated
− Notify users when they have
tasks or approvals waiting
for them. Automatically
escalate problems to
management.
a logged in user from a
dashboard list in the
application.
 User defined
− Simple and quick
configuration of user
defined actions to support
your process.
12
Vitatech Design
Master Quality Records and Inspection Records
Quality documents
finalized with
attachments and
approved in
QMS
Quality
Master
Data
Quality Orders
& Inspection
Records
Item Master and
Transaction Data
Production
QXtend
Master Data
QMS
Select Activities
ERP System
Official records,
e-Signed
4
System Functionality Comparison
User Requirements
Test Specification Reporting
System Generated Quality Orders
Audit Trails
Electronic C of A
Mobile Device Entry of Inspection
Results
Integrated Document
Management System
Electronic Signature
Electronic Version Control
Email Notification of Tasks
Attachments for Lab Results
CAPA/NCR Functionality
QAD Quality Module
QAD QMS
QMS Project Timeline
TASKS
Requirement Definitions
QMS System Software Training
(Cloud)
System Design for Vitatech
Configuration
Hardware & Software Installation
(on premises)
Q-Extend Integration Mapping
Validation Activities
End User Training
Update All Affected SOP's &
Process Maps
GO LIVE
Phase II Expanding All Areas
JUL
AUG
SEPT
OCT
NOV
DEC
System Design Flow Chart
1
Vitatech and QAD QMS
 QMS changes documentation practice
 Quality procedures do Not Change
1
Approval – E Signature

1
Next Steps…Full Company Rollout
All Product Lines
1
Save the Date for
Explore 2015
www.qad.com/explore