Digitized Automation for a Changing World

Delta HMI DOP-300 Series

FDA 21 CFR Part 11 Compliant

For the Medical, Pharmaceutical, and Food & Beverages

Industries
The Delta HMI DOP-300 Series complies with FDA 21 CFR Part 11 and is designed
to ensure data accuracy, integrity, and traceability. With the FDA 21 CFR Part
11 compliance, the DOP-300 is an ideal solution for machines in the medical,
pharmaceutical, and food & beverages industries

www.deltaww.com
To comply with 21 CFR, the DOP-300 Series primarily
addresses the following aspects

Compliance with Electronic Records

Ensures that electronic records are generated, stored, and
managed in a manner that maintains the integrity and reliability
of the records.

Electronic Signatures
(Secure Account Management)
The system administrator has settings access to create new
accounts, lockout users, and de-authorize them, but no one has
access to user passwords. Changes can be logged while the
runtime is not operating.

System Security
Ensures the systems have appropriate security controls, such as
user authentication and access control, to protect records from
unauthorized access or alteration.

• The Delta HMI DOP-300 Series complies with the FDA 21 CFR and ensures data
accuracy, integrity, and traceability. The following pages briefly introduce how the
DOP-300 Series supports the compliance with 21 CFR.
※ Please refer to the DOP-300 Series User Manual for more detailed setup and product information.

2
FDA 21 CFR Compliant Functions

Account Management

3 5

1 Security password 5 Password duration

The password length should be at The expiration date of the user
least 8 digits account can be pre-set, and the
system deletes it after expiration
2 Complex passwords
At least one uppercase and 6 Block / unblock
lowercase letter, number, and symbol Specific user accounts can be
blocked but still exist in the system
3 Unique user account
Unique account to ensure data security

4 Limitation of password attempts

Set the number of consecutive failed
password entries before the account 6
is disabled

3
FDA 21 CFR Compliant Functions

Operation
7 User actions are recorded with timestamps to create an audit trail
The record includes the following information:
• User creation • Login attempt
• User login / logout • Old / new value after data change
• User block / unblock by administrator • Timestamp

Time

Data Backup
8 The DOP-300 Series supports the following protocols for data sharing with
SCADA, MES, and ERP systems: FTP, USB/SD, and OPC UA

Path:【DIAScreen】→【Configuration】→【Network Setting】→【FTP】

4
Path:【DIAScreen】→【Configuration】→【Main】→【Non-volatile】

Path:【DIAScreen】→【IIoT】→【OPC UA Server】

Path:【DIAScreen】→【Communication】→【OPC UA Client】

5
FDA 21 CFR Compliant Functions

Electronic Records
9 Historical data, alarms, and operation log reports
The DOP-300 Series generates historical data / operation logs, and sends alarms

History Buffer Operation Log

Alarm

10 The storage space will vary based on report generation or the percentage of
memory used
When there's too little memory left, the pop-up window is displayed.
The DOP-300 Series storage space can be set through the Configuration tab

6
Report Merge & Printing
11 Batch report
The DOP-300 Series consolidates historical data, recipe, alarms, and operation
logs into a PDF report

12 Data print-out
Supports 16 printer drivers of different brands
(Honeywell, HP, EPSON, ZEBRA, GoDEX, Micro Printer, PDF Writer, and more)

Ordering Information
Ethernet Serial
Product Dimensiions CPU RAM ROM DIACloud Model Certificates
Port Port
HMI 7 inches Dual Core DOP-3S07S3E2
512 MB 512 MB 2 3 Built-in CE, UL
DOP-300 10.1 inches 1.2 GHz DOP-3S10S3E2
1. To ensure usage rights, please activate and use it within two years after shipment from Delta, and it will be valid within one
year after activation.
2. For more details, please refer to DOP-300 catalog.

7
Industrial Automation Headquarters
Taiwan: Delta Electronics, Inc.
Taoyuan Technology Center
No.18, Xinglong Rd., Taoyuan District,
Taoyuan City 330477, Taiwan
TEL: +886-3-362-6301 / FAX: +886-3-371-6301

Asia EMEA
China: Delta Electronics (Shanghai) Co., Ltd. EMEA Headquarters: Delta Electronics (Netherlands) B.V.
No.182 Minyu Rd., Pudong Shanghai, P.R.C. Sales: [email protected]
Post code : 201209 Marketing: [email protected]
TEL: +86-21-6872-3988 / FAX: +86-21-6872-3996 Technical Support: [email protected]
Customer Service: 400-820-9595 Customer Support: [email protected]
Service: [email protected]
Japan: Delta Electronics (Japan), Inc. TEL: +31(0)40 800 3900
Industrial Automation Sales Department
2-1-14 Shibadaimon, Minato-ku BENELUX: Delta Electronics (Netherlands) B.V.
Tokyo, Japan 105-0012 Automotive Campus 260, 5708 JZ Helmond, The Netherlands
TEL: +81-3-5733-1155 / FAX: +81-3-5733-1255 Mail: [email protected]
TEL: +31(0)40 800 3900
Korea: Delta Electronics (Korea), Inc. DACH: Delta Electronics (Netherlands) B.V.
1511, 219, Gasan Digital 1-Ro., Geumcheon-gu,
Coesterweg 45, D-59494 Soest, Germany
Seoul, 08501 South Korea
Mail: [email protected]
TEL: +82-2-515-5305 / FAX: +82-2-515-5302
TEL: +49 2921 987 238
Singapore: Delta Energy Systems (Singapore) Pte Ltd. France: Delta Electronics (France) S.A.
4 Kaki Bukit Avenue 1, #05-04, Singapore 417939 ZI du bois Challand 2, 15 rue des Pyrénées,
TEL: +65-6747-5155 / FAX: +65-6744-9228 Lisses, 91090 Evry Cedex, France
Mail: [email protected]
India: Delta Electronics (India) Pvt. Ltd. TEL: +33(0)1 69 77 82 60
Plot No.43, Sector 35, HSIIDC Gurgaon,
PIN 122001, Haryana, India Iberia: Delta Electronics Solutions (Spain) S.L.U
TEL: +91-124-4874900 / FAX: +91-124-4874945 Ctra. De Villaverde a Vallecas, 265 1º Dcha Ed.
Hormigueras – P.I. de Vallecas 28031 Madrid
Thailand: Delta Electronics (Thailand) PCL. TEL: +34(0)91 223 74 20
909 Soi 9, Moo 4, Bangpoo Industrial Estate (E.P.Z), Carrer Llacuna 166, 08018 Barcelona, Spain
Pattana 1 Rd., T.Phraksa, A.Muang, Mail: [email protected]
Samutprakarn 10280, Thailand
TEL: +66-2709-2800 / FAX: +66-2709-2827 Italy: Delta Electronics (Italy) S.r.l.
Via Meda 2–22060 Novedrate(CO)
Australia: Delta Electronics (Australia) Pty Ltd. Piazza Grazioli 18 00186 Roma Italy
Unit 2, Building A, 18-24 Ricketts Road, Mail: [email protected]
Mount Waverley, Victoria 3149 Australia TEL: +39 039 8900365
Mail: [email protected]
Turkey: Delta Greentech Elektronik San. Ltd. Sti. (Turkey)
TEL: +61-1300-335-823 / +61-3-9543-3720
Şerifali Mah. Hendem Cad. Kule Sok. No:16-A
34775 Ümraniye – İstanbul
Americas Mail: [email protected]
TEL: + 90 216 499 9910
USA: Delta Electronics (Americas) Ltd.
5101 Davis Drive, Research Triangle Park, NC 27709, U.S.A. MEA: Eltek Dubai (Eltek MEA DMCC)
TEL: +1-919-767-3813 OFFICE 2504, 25th Floor, Saba Tower 1,
Jumeirah Lakes Towers, Dubai, UAE
Brazil: Delta Electronics Brazil Ltd. Mail: [email protected]
Estrada Velha Rio-São Paulo, 5300 Eugênio de TEL: +971(0)4 2690148
Melo - São José dos Campos CEP: 12247-004 - SP - Brazil
TEL: +55-12-3932-2300 / FAX: +55-12-3932-237

Mexico: Delta Electronics International Mexico S.A. de C.V.

Gustavo Baz No. 309 Edificio E PB 103
Colonia La Loma, CP 54060
Tlalnepantla, Estado de México
TEL: +52-55-3603-9200

*We reserve the right to change the information in this catalogue without prior notice.
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