Acctrue is a leading Chinese software company that provides track and trace solutions. It introduces its track and trace system, which is designed to meet China's CFDA requirements for electronic supervision of drugs. The system allows full supply chain traceability and includes features such as labeling, scanning, aggregation of data, and interfacing with the CFDA system. It provides consultation services and an electronic supervision software system to help customers implement track and trace for imported drugs in accordance with China's regulations.

1. 360° 供应链管理专家
January 1, 2009 Date
中 国 物 联 网 行 业 先 锋
The general solution of
EDMC of CFDA on
imported drugs
Acctrue Technology
Leo Zhang(Sales Manager)
Liuwenxi (Technical Director)
1

2. 中国物联网行业先锋
1. Acctrue Brief
2. T&T Requirements from CFDA
3. Acctrue T&T System Design
5. Delivery And Service
4. Acctrue T&T System Introduction
Contents

3. 3
中国物联网行业先锋About us
Founded on 1998 at Beijing, Acctrue is one of the national
key software enterprise with double software certification
in Beijing.
We have more than 400 employees who distributed at 8
regions throughout China.
We are the first enterprise that implemented
pharmaceutical electronic supervision code e-coding
system in China.
Our Track & Trace solution has been widely used in more
than 15000 production lines accross15 different industries.

4. 4
中国物联网行业先锋
4
Acctrue is high-tech enterprise of National Torch Plan,
supported by technology support funds of National
Development and Reform Commission, Ministry of
Industry and Information Technology
Acctrue provides the solution consultation, self-owned
software as well as hardware integration.
With more than 12 software patent and 77 software
copyright, Acctrue has been recognized as the leading
supplier in the field of industry software.
From 2005,Acctrue had implemented projects for more
than 2000 pharmaceutical clients, domestically and
globally. 18 of Top 25 global pharmaceutical companies
adopted our solutions.

5. 中国物联网行业先锋Full Supply Chain Traceability Solution
5
ERP/OA
procure inventory production quality finance sales
Production
quality mgt
Market
mgt
Anti-fake,
transshipment
sales
Material
warehouse
mgt
Raw
material
mgt
Plan, material
inputting mgt
Labeling and
scanning
Finished item
warehouse
mgt
Distribution
direction
mgt
Raw material
procure
Material inputting
in production
Packaging
barcoding
System Interface
Raw material
inventory
Product
inventory
Distribution
mgt
Tracking
Consumer
mgt
Post sales
service mgt
Tracing
Quality
mgt
Note：
Mgt=management

6. 中国物联网行业先锋
QA/REWORK
Station
Warthouse Station
Manufacturing sites – Process and integration levels
Running Batch Modify Batch Shipment Modify Shipment
Level4Level3Level2Level1
Enterprise
Application
Site
Application
(For each site)
Line Controller
(For each line and
Reworking station)
Device Level

7. 7
Pioneer of Chinese Internet of ThingsAcctrue Service
7
Consulting
Service
Production Line
/Equipment
Manufacturing
IT Outsourcing
Service
Software
Development/
Authentification
Service
T&T SW&
HW On-site
Delivery
Supply
Chain

8. 中国物联网行业先锋
8
Headquarter in Beijing
8 branches in China
1 branch in USA
Acctrue in China
Central Region
North Region
South Region
East Region
NEast Region
NWest Region
WSouth Region
Shan Dong Region

9. 中国物联网行业先锋
9
Awards and Recognition
 Beijing High-tech Enterprise Certification
 China Food Cold Chain Information Tracing Supplier
 China RFID Industry Union Member
 3 Beijing Independent Innovation Product Certificates
 China Food Cold Chain Information Tracing Supplier
 2012 Deloitte Asia Pacific Fast Growing High Tech Enterprise Top 500 Award
 2012 Deloitte China Fast Growing High Tech Enterprise Top 50 Award
 2012 The National Golden Card Project Gold Ant Award for Product Innovation
 2012 China Internet of Things Leading Enterprise
 2012 Most Competitive Brands in Pharmaceutical Industry Top 10

10. 10
中国物联网行业先锋
10
Certification

11. 中国物联网行业先锋
Global Pharmaceutical Customers
Customer Name Chinese Name Collaboration time
AstraZeneca China 阿斯利康中国 2010 ~ 2015
Sanofi-Aventis 赛诺菲中国 2010 ~ 2015
Novartis 诺华制药 2011 ~ 2015
Bayer Healthcare Group 拜耳集团 2010 ~ 2015
Pfizer 辉瑞 2012 ~ 2015
Roche 罗氏 2010 ~ 2015
Fresenius-Kabi 费森尤斯 - 卡比 2010 ~ 2015
MSD 默沙东 2010 ~ 2015
Lilly 礼来 2010 ~ 2012
Bristol-Myers Squibb 中美施贵宝 2011 ~ 2015
Grifols 盖立夫 2013~ 2015
Xian-Janssen 西安杨森 2010 ~ 2015

12. 中国物联网行业先锋
Global Pharmaceutical Customers
Customer Name Chinese Name Collaboration time
SSPC 华瑞 2010 ~ 2015
Boehringer-Ingelheim 勃林格殷格翰 2010 ~ 2015
Schering-Plough 先灵葆雅 2010 ~ 2015
Santen 参天制药 2011 ~ 2015
Sumitomo 住友制药 2011 ~ 2015
Ethypharm 爱的发 2011 ~ 2015
Tianjin Takeda 武田 2011 ~ 2015
Otsuka 大冢 2010 ~ 2015
Merck Serono 默克雪兰诺 2015

13. 中国物联网行业先锋
Top 10 Pharmaceutical Group customers in China
Customer Name Chinese Name Collaboration time
Shanghai Pharma Group 上药集团 08、09、10、11
Kelun Pharmaceutical Group 科伦集团 10、11
Harbin Pharmaceutical Group 哈药集团 08、09、10、11
Guangzhou Pharmaceutical Group 广药集团 09、10、11
China National Biotec Group 中生集团 08、09、10、11
Fosun Pharma Group 复星集团 08、09、10、11
NCPC Pharmaceutical Group 华北制药 08、09、10、11
Sinopharm Group 国药集团 08、09、10、11
Yangtze River Pharmaceutical Group 扬子江药业 08、09、10、11
North China Pharmaceutical Group 东北制药 08、09、10、11

14. 14
中国物联网行业先锋

15. 中国物联网行业先锋
T&T Requirement From CFDA

16. 中国物联网行业先锋Background and Status of System
Status
 So far four phase drug electronic supervision project had been promoted, and completed the whole
process supervision for six kinds of drugs..
In 2006 Narcotic drugs be the first experimental unit in China
In 2007 Class A psychotropic drugs (18 units in China)
In 2008 Bacterin, blood products, Chinese medicine injections and Class B psychotropic drugs
In 2010 Electronic Drug Monitoring code for the drugs in Essential Drug List
In 2013 Implement Electronic Drug Monitoring Code for imported drugs
In 2015 Complete the code supervision for all drugs. Electronic Drug Monitoring Code

17. 中国物联网行业先锋
CFDA T&T Project
Product File
XML
Electronic
Drug
Monitoring
Code
TXT
Aggregation
XML
Registration and
Sales Verification
Data
XML
Printing/
Stickng
Scanning
barcode
Exception
handle
Aggregation
Stock in
Stock out
Aggregation data file interface
GI/GR Data
interface
RegistrationandSales
VerificationSystem
T&T System
CFDA
Build aggregation
Items/Bundles/Case

18. 中国物联网行业先锋CFDA T&T Project ProcessAfterproduceProduceBeforeproduce
local
CFDA Web site/
Acctrue ESC
Enterprise/
Acctrue
Online approvalCFDA WebsiteEnterprise3、Download the
supervision code
Online applicationCFDA WebsiteEnterprise2,Apply the
supervision code
Online maintenanceCFDA WebsiteEnterprise1、Maintain Product
information
Business flow Operator Platform Place
Printing vendor--------Carton vendor
4、Test on the web
site
Plant officeCFDA WebsiteEnterprise
10、Scan goods
PlantAcctrue ESCEnterprise8、Aggregation
PlantAcctrue ESCEnterprise
7、scan/verify on
the production line
PlantAcctrue ESCEnterprise
6、Bundle/case Barcode
online printing
WarehouseAcctrue ESCEnterprise
CFDA WebsiteEnterprise
11、Upload logistic
data
 Flow plan
Plant office
5、Carton vendor
printing
9、Upload batch data

19. 中国物联网行业先锋
Printing Mode of Electronic Drug Monitoring Code
Label
 Definition
 The label of Electronic Drug Monitoring Code (EDMC)is composed by 20 supervision code
numbers, one barcode and hint information.
 The EDMC is the electronic ID number of each independently packaged drug, which can be
divided into the first supervision code, the second supervision code, the third supervision
code, etc.
 Label Mode
Mode A
Mode B
Mode C

20. 中国物联网行业先锋大箱监管码赋码规范
 Technical Guidance for Drug Electronic Supervision, item3.5. (5) When assigning
supervision codes to the maximum package of the drug, print the same supervision
code label for at least two copies and stick them horizontally on two mutually
orthogonal surfaces of the external package respectively for the convenience of
scanning when piling up the products. It had better to stick the supervision code label
near the product batch number on the external box for the convenience of information
management. In the meantime, to avoid the supervision code getting too close to the
bottom edge so that it becomes unrecognizable, it is recommended to maintain
minimum 30mm from the bottom of the supervision code to the carton bottom edge. As
it is shown in the figure:

21. 中国物联网行业先锋Printing Specification of EDMC Label
 Printing technical parameters of EDMC
 Code128C
 1D Barcode: Code128C
 Precision X≥7 mil
 Barcode Density: X≥7 mil
 H≥ 8mm
 Barcode Height: H≥ 8mm
 Printing position of EDMC
 Facilitate the scanning of production line and build association
relations
 Avoid being printed together with product barcode and other barcodes
 Printing direction of EDMC
 Color matching of EDMC
 Printing quality inspection method of EDMC
 The grade of barcode reaches C

22. 中国物联网行业先锋
22
The policy of imported drugs
 From 2012, some of the import drugs ,for example, narcotics, psychotropic drugs,
blood products, vaccine, Chinese injection drugs as well as the Class B
psychotropic drugs have been brought into the electronic supervision project.
 The import drug packaged in China domestic must be stick with barcode label by
the package vendor before 28,Feb, 2013
 The import drug packaged in oversea plant, The enterprise must stick the barcode
on the box before 28,Feb,2013, and stick the barcode on each level package
before 31,Dec,2013
 The enterprise must ready for the website accession , barcode sticking and
registration
 (Extract from the CFDA document[2012] 85, Release at 28,June,2012)

23. 中国物联网行业先锋
23
The latest policy of imported drugs
 Both manufacture and package supplier should register a account in china drug admin web site
 Import narcotics, psychotropic drugs, blood products, vaccine should be completed after 28,Feb,2013
 The muti-level package of these drugs subject to the marked manufacture date, The drugs produced after
Jan 1,2014 must stick the barcode according to the standard
 The EDMC code is applied to all levels of sales packaging except for pallets
 Aggregation relationships for all levels of packaging must be maintained and included in China government
reporting
 The Class B drugs must stick barcode at 12 later when it register in CFDA. All drugs must stick the barcode
at the end of 2015.
 The local CFDA supervise the import drugs, the drugs mismatch the standard would be refused.
 The supervise organization depends on the registered office.
 The photo of EDMC code and lot number must be provided in the process of import drugs check in..
 By the deadline of Dec 31 2015, all the import drugs must serialized at the plant that registers on CFDA file,
before entering in China.
 http://www.sda.gov.cn/WS01/CL0516/

24. 360° 供应链管理专家
January 1, 2009 Date
中 国 物 联 网 行 业 先 锋
What Acctrue can provide?
24

25. 中国物联网行业先锋What we can offer：
25
1st，Consultation service
1、Policy Interpret,
2、 Technical support ,registration support, test support
3、Business flow planning
4、Risk evaluation, Supplier evaluation
5、Surrounding system integration
2nd，Acctrue ESC software
1、ESC(electronic supervision system)
2、PDM(electronic supervision data management system)
3、Warehouse terminal
3rd，Project implementation
1、Development
2、Software deployment
3、Software deployment/hardware installation debug/production line
improvement
4、Training
5、System validation
4th，Technical support post sale.
1、support for execution flow
2、remote support
3、on site support

26. 中国物联网行业先锋Sample: the consultation delivery
Policy interpret
CFDA Policy summary about electronic supervision
Policy analysis and business influence evaluation
Further explain to supervision specification
CFDA Interface Technical support
Aggregation data interface
Logistic data interface
CFDA software client.
Q&A
Business plan
Survey report to current business flow
General business flow proposal
SOP
Import drugs project proposal
Risk evaluation
Risk evaluation report
Surrounding system integration plan
System interface design document
System interface program
System interface validation

27. 中国物联网行业先锋General Solution
27
 Production line
improvement solution
 Purchase HW/SW
 On site implementation
 FAT
 IQ,OQ,PQ
 SAT
 Product information
 Local GMP requirement
 Survey to production line
 IT infrastructure
 Surrounding system

28. 中国物联网行业先锋
Acctrue T&T System Design

29. 中国物联网行业先锋General Business Flow Design
29
China
Warehouse
ESC
system
Domestic office
Oversea
plant
USB
Key
Oversea
CFDA
Logistics
Logistics
Supervision
code file
①Stock in && Stock out
②Sampling
③Customer Return of
goods
④Destruction
Aggregation files
Supervision
code
Custom/General
distributor
Oversea
warehouse
Aggregation
files

30. 30
中国物联网行业先锋System Architecture Design

31. 31
中国物联网行业先锋Network Architecture Design

32. 中国物联网行业先锋Typical Packing Line Process Design
32

33. 中国物联网行业先锋Packing Line Layout Design Example
33

34. 中国物联网行业先锋Signal Interface Design(optional)
34
Signal Source Signal Objective NOTES
T&T system Packing Line
If the reject station failed, T&T system client will send
a stop signal to the packing line.
Emergency stop signal: T&T system client will send a
stop signal to packing line.
Packing Line T&T system Emergency stop signal: Packing Line will send a stop
signal to the T&T system client
After the case packer finish a case , it will send a
finished case signal to the T&T system

35. 中国物联网行业先锋Acctrue T&T System (Video)
• Application video on plants
• https://www.youtube.com/watch?v=bSVGKsL2NpU
• https://www.youtube.com/channel/UCuBC0sbQBS7RMQDEeTB78Mw
35

36. 中国物联网行业先锋
Acctrue T&T System
Introduction

37. 37
中国物联网行业先锋Full Layer scanning
Reduce manual
operation

38. 38
中国物联网行业先锋Standard Industrial Design
Normative Wiring;
Separate light-current
and strong-current;

39. 39
中国物联网行业先锋Role/User/ Authority Management
Three grade authority mode
System can grant different permissions to
different role or user, to control whether this role/user
can access the specific function/resource or not
Support to integrate with AD
Strong Password management
Support to lock the production Client
Packing Line permission management
Role Permission
Planning Import product information function
Import EDMC files function
Password management
Export Aggregation file function
Export EDMC file to carton vendor function
Audit trail log (own user actions only – read only)
Operator Hand held scanner functions
Password management
Query EDMC function
Audit trail log (own user actions only – read only)
Packing
line
manager
Production task management function
Production management function
Hand held scanner functions
Query EDMC function
Password management
Audit trail log (own user actions only – read only)
administr
ator
All functions
Audit trail log ( all user actions - read only)
Warehous
e operator
Hand held scanner functions
Password management
Query EDMC function
Export logistics data function
Audit trail log (own user actions only – read only)
QA Hand held scanner functions
Password management
Query EDMC function
Audit trail log (own user actions only – read only)

40. 40
中国物联网行业先锋Strong data collection and display function

41. 41
中国物联网行业先锋Packing Line Monitoring

42. 42
中国物联网行业先锋Production Report
Help users to analyze and improve OEE

43. 43
中国物联网行业先锋Audit Trail
All operation will be recorded. These logs can not be modified.
The audio trail logs can be exported.

44. 44
中国物联网行业先锋Early warning
※ It can warning the quantity of the remaining T&T codes
whether is enough. (for pre-print codes)
※ It can notice system administrator by mail.
※When the packing T&T system task be started, system can
check whether the bundle/case codes is enough or not.

45. 中国物联网行业先锋Deployment of Group
 Deployment of Group:
 Under the deployment of group, the Web server and database server are
severally deployed on the independent physical server. In order to ensure
the performance and high practicability, the Web server and database
server are deployed in the way of Cluster and the coding execution
software is deployed on the single industrial control computer.
 Advantages
 The database and Web server are separate, which further improves the
processing speed and processing ability of system, provides the ability of
single point fault and increases the reliability and practicability of system.
 Scope of application:
 Apply to the enterprises with a large number of production lines and great
output, especially to the group enterprises. The production line of the
whole group can be uniformly managed.
45
Plant area 1
Production
line 1 Plant area 2
Machine used for
industrial control 1
Machine used for
industrial control 2
Machine used for
industrial control 3
Machine used for
industrial control 3
Machine used for
industrial control 4
Center computer house
Database server
Web server
Production
line 2 Production
line 3

46. 中国物联网行业先锋
 Standard Deployment:
 Under the standard mode, the Web server and database server are deployed on a
independent physical server, the coding execution software is installed on the industrial
control computer, the server can manage several industrial control computers, and each
industrial control computer can manage one or several production line.
 Pros: Adopting this mode to separate the industrial control computer and server, it can
effectively ensure the pressure of server not too large and the normal production of
industrial control computer.
 Cons：A impendent server with UPS is needed and the cost is relatively high;
 The database server and Web server are deployed together, which can’t sustain too
many industrial control computers;
 Scope of application: apply to the enterprise with many production lines, fast
production speed, great output and normative management.
 Standard mode is recommended to the deployment of general enterprise.
46
Standard Deployment (Reference)

47. 中国物联网行业先锋
47
 Compact Deployment:
 Under the compact mode, the Web server, database server
and coding execution software are synchronously installed on
a same industrial control computer.
 Pros:
 Three function modules are deployed on an industrial control
computer, which doesn’t need the support of special server
and saves the cost.
 Cons:
 The industrial control computer has a high load and can’t
complete the production tasks with high speed and large
quantity.
 Scope of application:
 This mode applies the enterprises with small product package
sorts, small package quantities, slow speed and small package
workshop space or the enterprises with scattered production
line positions.
Compact Deployment (Reference)

48. 中国物联网行业先锋
Advantages of Accture Visual Solution
48
Advance
technology
Mature
interface
Strong
adaptabili
ty to
environme
nt
Advanced technology, visual system could obtain a more
clear image and meet various modes such as character
recognition, bar code recognition and 2-dimentional bar code
recognition, etc.
Having a high tolerance to the
environment and possessing the
industrial level application
technology
Seamless integration with
tagging software
Typical Case of Accture
Visual Solution
Bayer Healthcare (the
first in the
pharmaceuticals industry
in China to adopts visual
solution
Astra Zeneca
Xi’an Janssen
Wuhan Mayinglong
Novartis Pharmacy

49. 中国物联网行业先锋System Abnormality During Production
Power
outage in
production
Self-
restoration
of State
System
crash
Mis-
operation by
the
personnel
Automatic
saving of
production
data
Self-restoration
of production
task

50. 中国物联网行业先锋Providing Customers Training Model
Feel at ease and be bold to operate
Customers
Training Model
Training Produce rubbish data
Influence Production data
Virtual environment
Live experience
Training and learning will be
more visualized and convenient
It will not influence the actual
production environment data

51. 中国物联网行业先锋
多仓库数据管理
Multi-storages Data Management
5151
互联网
出库文件
出库文件
出库文件
Stock
out
docu
ments
厂区内仓库
Storages in the factory 电子监管网平台
Electronic
supervision
network platform
仓库管理人员
Management personnel of the
storage
文件上传
管理人员
Management personnel for
uploading documents
爱创产品数
据管理系统
Acctrue products
data management
system
高架库
High-rack storage
人工传递
互联网
平库
Flat Storage
厂区外部仓库
Storages outside of the factory

52. 中国物联网行业先锋System Compatibility
52
 Database
management
system support
ORACLE or
SQLSERVER
 Support multi-version
operation system of Windows
 Support all versions of IE
and other mainstream
browsers such as Fire Fox
 Support C/S
And B/S Clients

53. 中国物联网行业先锋
Delivery And Service

54. 中国物联网行业先锋
Project detail Plan(sample)

55. 中国物联网行业先锋
CSV(Based on GAMP5)

56. 中国物联网行业先锋
RISK & Quality Management(RTMIRMFMEA)

57. 中国物联网行业先锋Post-sales Service
 “4 Dimension” Service
 1. On-site support
 2. 7*24 hot line support
 3. Remote support by Acctrue’s senior engineers
 4. Train 2 employees into AE ( Engineer up to standards of Acctrue)
Golden Service
 Problem clarification time after error reporting, it will be immediately / up 4h
 Problem treatment time will be in 1 work day.

58. 360° 供应链管理专家
January 1, 2009 Date
中 国 物 联 网 行 业 先 锋
Thank you !