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Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS-ER-PACK LSDB/ER-PACK LSCS
Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS-Kyoto Electronics Industry Co., Ltd.

Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS
Kyoto Electronics Industry Co., Ltd.


About This Product

This personal computer software was developed to support AT-Win/KF-Win in complying with the regulations regarding electronic records (FDA 21CFR Part 11) issued by the US Food and Drug Administration (FDA) in August 1997. FDA 21CFR Part 11 support functions are achieved by combining a personal computer with database management software (LabSolutions DB / LabSolutions CS) installed and a measurement device.

■Supporting support for electronic records and electronic signatures

Data access management (recording) using user ID and password is possible when changing data. In addition, data approval operations can be performed using the approval workflow ("Confirm", "Consideration", "Approve", "Cancel", "Disapprove", "Reject", "Remand").

■Enhanced electronic signature and security using ID and password

- User authentication security is achieved through login/logout processing using login ID and password. - Password length, expiration date, etc. can be set in detail for each user. It also has a lockout function for unauthorized access and a recording function for unauthorized access. ・When you are away from your seat, you can lock AT-Win/KF-Win.

■Authority group creation function

It is possible to create "Authority Groups (Analysts, Data Viewers, Data Reviewers, Approvers, etc.)" that summarize privileges according to work content. *For AT-Win/KF-Win operation privileges, configure security settings for each software.

■Supporting support for electronic records and electronic signatures

When changing data, data access management (recording) is possible using user IDs and passwords.

■Electronic signature with ID and password, enhanced security

User authentication security is achieved through login/logout processing using a login ID and password.

■Serial port

RS-232C D-SUB (male) 9 pins: 1 port required *An individual serial port is required for each measurement device. Also, a separate serial port is required when connecting a balance, barcode, etc. to a computer. *Up to 4 units can be connected by adding an RS-232C expansion board (optional). However, at least one empty slot is required for PCI Express.

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    Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS

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1 Models of Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS

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Electronic records/electronic signature support software ER-PACK LSDB/ER-PACK LSCS-Part Number-ER-PACK LSDB/ER-PACK LSCS

ER-PACK LSDB/ER-PACK LSCS

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