Grasp these three points and let the falsification of vaccine production records disappear.

DATE:2019-08-05
Number of visits:18
Recently, "vaccines" and "medicines" have become hot topics, the reason is that the production records of rabies vaccines of perennial organisms are fraudulent. At present, the State Drug Administration is organizing the national regulatory forces to conduct a thorough investigation of the whole chain of production, sales and other processes. How do pharmaceutical companies improve their records? In case of investigation?
In fact, the standard or standard of 21CFRPart_11 electronic record and electronic signature is a good record and verification standard.
21 CFR Part 11 Background Link
In March 1997, the FDA promulgated Article 11 of the Federal Act (21 CFR Part 11), which states that under certain conditions, electronic records, electronic signatures, paper records and handwritten signatures of paper documents are equally valid. This provision applies to all areas of the FDA and aims to allow the widespread use of electronic technology in line with the responsibilities of the FDA and to protect public health. With the development of cGMP for human, veterinary and biological products, the US FDA re-examined 21 CFR Part 11. The FDA requires that records be kept or submitted in compliance with regulations. For records that do not conform to regulations, the FDA will take regulatory action. FDA requires that records be kept in accordance with regulations, in addition to paper forms, there are electronic forms to keep records, and relevant regulations are operated according to records.
21CFRPart_11 is widely accepted and implemented by biomedical enterprises, hospitals, research institutes and laboratories in the United States. Since its promulgation, it has been extended to the whole world. Although it is not mandatory, it has been widely accepted and used by maps and countries in Europe and Asia.

In 21 CFRPart 11, authority management, audit tracking and electronic signature are indispensable.
        Taking Huideyi QuikSep series tomographic system as an example, this paper expounds how to realize the authenticity and security of electronic records.

Historical data, system logs
All historical data are stored in the system hard disk for viewing. The historical data includes signal curve, log, method, etc. The system log can record all operation and alarm information from start to end.

Authority Management
QuikSep series chromatography system uses five levels of management authority: Engineer, Administrator, Power User, Operator, Guest. Users can add any number of users and assign them to different permission groups at the same time. Permission groups have different permissions, which can be assigned by administrators. Administrators can add, modify and delete users.
At present, QuikSep series tomography system has 13 privileges open to users for privilege allocation, as shown in the following figure.
        When handover or temporary departure occurs, lockout control is sometimes required to prevent other people from misoperation or malicious operation. At this time, all control functions can be locked by clicking "Lockout Control" in the menu. The system continues to operate, but all control buttons, including valves, pumps, operation control, and marking functions will be available. Locked, logged in again以后即可解锁控制。
Audit Tracking
Audit tracking, in short, is permission allocation, user login and login, password modification, key configuration modification and other information, software systems can be recorded to facilitate future checks can be traced back. After users log on to the system, they need corresponding permissions to view audit tracking records. Click "Audit Tracking" to pop up the Audit Tracking dialog box, as shown in the following figure.

        After starting QuikSep series tomography system, the system will mark the absolute time and input the operation activities into the database in order. Therefore, if the system time is modified and the data is modified, it can be traced back through the "audit tracking" function. Users can also export records to external files by clicking "Export Records".

electronic signature
Electronic signature refers to the compilation of arbitrary symbols or a series of symbols that are executed, adopted or approved by one person to be computer data with the same validity as his own handwritten signature. Electronic signature includes user name and password input, as well as the right to replace handwritten signature with electronic signature for electronic records. Tracking these information often generates a tamper-proof electronic record.
After selecting the data file, you can see the "Data Signature" button on the history curve page. Click on this button and the signature dialog will pop up.

On the "Signature" page, the user who chooses to sign, enters the signature password, enters the description of the signature, and finally clicks "Sign" to realize the signature of the document.
"Lock" chooses to lock the file. Check this option. After executing the signature, the file will be locked. The locked file will no longer be allowed to sign.
On the "Signature Records" page, you can view the history of all signatures.
If you need to modify the signature password, you can go to the "User Access" menu "Change the signature password" for modification.


Concluding remarks

The suspected falsification of production records in vaccine enterprises has attracted wide attention. The authenticity of production records is directly related to the quality of drug production. Seriously speaking, it is also related to the health and safety of citizens, so it can not be ignored. Strengthening the management of electronic records of production equipment to make the whole production process traceable and unalterable is the most powerful means to ensure the authenticity of production records and the controllability of drug production process and production quality.