1. The copy of data records must be accurate and complete

2. All related records must be modified retroactively

3. Controllable copy of data records

4. Time stamp marking, tracking review of record changes that are not user-dependent

Electronic records

For closed systems

Systems. Predictability of functions, and detection of illegal or altered records (this is mainly realized by digital signature in software)

The system can provide accurate and complete copies of required data records, which can be read by people and reviewed by FDA in the form of electronic records. Data record files can include various forms of files, ranging from data generated by instruments to printable reports, such as PDF and Office series documents, and the final report should also contain audit and tracking information. In the whole life cycle of data, it is necessary to ensure its correctness and retrievability. The general solution to this problem is to store the data in a central server, and use the database management system for standardized management. The system administrator manages the server to control the user access verification method and the password update frequency. Assign users corresponding roles and permissions, including access to data resources and access to system functions. For all user operations, the server should be able to record truthfully and safely, such as date, time, user's operation activities (addition, deletion, modification) and even need to give the reasons for the corresponding operations compulsorily, and form a secure log file for future tracking (this file should also be stored on the server in general).

if a file is modified, the previous version should be completely preserved. The retention of the above tracking information should run through the whole execution cycle of the document (document generation, archiving and destruction).

system inspection and control

the system should be authorized to verify the login and authorized use of legal users

people who use electronic documents need to receive education and training

to establish writing permission, they must be responsible for digitally signed documents and understand that the signature is as effective as the signature on paper

for an open system

the expression of signature: signer's name, date and time, and reason for signing < The general solution is to make the electronic signature a part of the document.

All electronic signatures belong to only one person, and cannot be reused and redistributed by anyone else. Before signing, there must be strict authentication methods (password, biometrics).