YOSHINO Yasuhiro1 FUKUHARA Tatsuya1 NAGUMO Yasushi1 FUJITA Yasuyuki1
We have developed DAQSTATION DX100P/DX200P paperless recorders for pharmaceutical (DX-P) and dedicated software DAQSIGNIN complying with the requirements of 21 CFR Part 11 which is the regulation for electronic records and electronic signatures set by the Food and Drug Administration (FDA) in the USA. With the enhancement in security and audit trails, DX-P and DAQSIGNIN have earned the FDA compliance statement from a consulting firm, Stelex Inc. DX-P and DAQSIGNIN are expected to accelerate the digitalization of data for quality control and process control among the pharmaceutical and food industries. Many pharmaceutical companies have already started trial operations and some have adopted them.
This paper outlines items necessary to meet the requirements of 21 CFR Part 11, how DX-P meets these requirements and introduces DX-P's remote control function and DAQSIGNIN software for DX-P.
|Figure 1 The DX100P and DX200P|
As groups of sensors in the field became intelligent and capable of handling not only simple data, but also so-called "information" with added values such as error detection and statistical analysis, recorders became required to play a role in transmitting such information. The DAQSTATION DX Series that YOKOGAWA released in 1999 are paperless recorders meeting this need.
Also as to the food and pharmaceutical industries that had been said to be difficult to digitize quality control or process control data, the Food and Drug Administration (FDA) of the USA issued 21 CFR Part 11 (Electronic Records; Electronic Signatures) as a guideline for magnetic media for recording during the manufacture of pharmaceuticals in 1997. This time, with the enhanced security functions of the DX paperless recorders, we have developed the DX-P Series, the first in the world to be 21 CFR Part 11 compliant. They are shown in Figure 1.
It has been approved by Stelex Inc., a consulting firm in the USA, that the DX-P Series complies with the requirements of 21 CFR Part 11.
Table 1 Validation Documents
|White Paper||Document explaining that a product complies with 21 CFR Part 11|
|IQ (Installation Qualification)||Regulation for approval of the installation method of equipment|
|OQ (Operational Qualification)||Regulation for approval of the operation method of equipment|
Separation of the network functions into a setting server and a monitor server allows setting changes and control to be carried out using communication commands. To be compliant with audit trails, logging in must be through the setting server and with exclusive keystrokes, restricting the number of users that can operate a DX-P recorder to be always one.
Provision of a monitor server that can be continuously connected also allows measured values in the DX-P to be monitored. Table 2 shows the network servers provided for the DX-P Series.
Table 2 Network Server Functions
|Setting server||Allows the same operations as keystrokes on a DX-P recorder. Note that it cannot make a connection during a login made with keystrokes on the recorder.|
|Monitor server||Allows only monitoring of measured data. It makes a connection even during a login with keystrokes on the recorder.|
|FTP server||Functions supported:
Directory output (DIR)
File acquisition (GET)
|Web server||Displays the screen image of a DX-P recorder. It allows only switching of a screen and requires a dedicated user name and a password.|
As shown in Figure 2, the combined use of the web browser- based monitoring function, e-mail communication function, and FTP client function, which have been incorporated from the DX Series, allows remote monitoring within the network environments. However, the DX-P is an instrument that is to be basically used in a closed network and thus needs to be controlled so that only persons having access rights to the DX-P recorder can gain access even when it is used in a network configuration.
Figure 2 Examples of the Use of DX-P in Network Environments
In order to support electronic signatures as required by 21 CFR Part 11, the DX-P is equipped with an infrared remote control function to improve the character input method. This feature allows remote control equivalent to keystrokes on a DX-P recorder in addition to simplified character input, which also improves the operability of the recorder. Moreover, the DX-P can incorporate the dust-proof and drip-proof specifications (IEC 529-IP65) of the front panel, one of the features of the existing DX Series because the remote control terminal is of the wireless type. Figure 3 shows the remote control terminal.
The remote control terminal allows operations of all keys on a DX-P recorder. The use of an ID code for identifying a model and an ID code set on a DX-P recorder allows a maximum of 32 DX-P recorders to be operated.
|Figure 3 The Remote
DAQSIGNIN is the standard software provided with the DX-P that facilitates the placing of electronic signatures on data files created on a DX-P recorder by means of a PC. This software allows you to check data, check audit trails, and place your electronic signature on data using a PC. Moreover, in Rev. 3.01 and later a function to send configuration data to the DX-P recorder has been added. This software consists of the following four types of software:
|Figure 4 Manager Software||Figure 5 Data Viewer Software|
This paper has described the DAQSTATION DX100P/ DX200P paperless recorders developed for the food and pharmaceutical industries, centering on their compliance with 21 CFR Part 11. The DX-Ps are the world's first paperless recorders compliant with 21 CFR Part 11, and have already undergone trial operation by a number of pharmaceutical manufacturers as they are expected to accelerate the digitization of quality control and process control data. In Japan, work toward meeting the requirements of 21 CFR Part 11 has been delayed, but we anticipate that there are positive moves toward the practical application of the DX-P.
In future, we plan to work toward making the DX-P a standard tool for the food and pharmaceutical industries by incorporating feedback from the users who have been involved in the trial operations.
Model Names: DX100P and DX200P
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