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Shanghai Shang Shaft Bearing Quality Inspection Institute Co., Ltd.

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Address: 301 Shangxue Road, Jiading District, Shanghai

What are the requirements for copying paper records and modifying electronic records?

2020-07-02 15:00

Management requirements for paper and electronic records

Paper Record Management Requirements


1. The design and creation of record documents should meet the actual use, the style should be easy to identify, record, collect, save, trace and use, and the content should be comprehensive, complete and accurate to reflect the corresponding activities.


2, the provisions of the record document review and approval responsibilities, clear record document version effective management requirements, to prevent the use of invalid version.


3. The printing and distribution of record documents should be based on the different uses and types of records, using controlled methods equivalent to the importance of records, and must prevent the record from being replaced or tampered.


4, clear record of the record responsibilities, shall not be replaced by others, and the use of long-term preservation, not easy to remove the tools or methods.


The original data shall be recorded directly on the specified records and shall not be temporarily written or transcribed through uncontrolled carriers.

For example, it is not allowed to find a blank sheet of paper to replace the record form.


5. Any changes to the record shall be endorsed with the name of the person who modified it and the date of modification, and the original information shall be kept clearly identifiable. Explain the reason for the change, if necessary.


6. The collection time, archiving method, storage location, storage period and management personnel of the records shall be clearly defined, and appropriate preservation or backup measures shall be taken. The retention period of records shall meet the requirements of relevant regulations.

For example, the original records must be kept for at least 6 years.


7. The use and reproduction of records shall take appropriate measures to prevent the loss, damage or tampering of records.

Copy RecordsThe method of approval, distribution and control of the copy of the record shall be stipulated, and the original and copy of the record shall be clearly distinguished.


8, should determine the appropriate record destruction method, and establish the corresponding destruction records.

For example, the records cannot be destroyed by the cleaning aunt of the laboratory.



Electronic Records Management Requirements


1、Computerized systems using electronic records should meet the following facilities and configurations:

(1) Install in an appropriate position to prevent interference from external factors;

(2) Servers or hosts that support the normal operation of the system;

(3) Stable and secure network environment and reliable information security platform;

(4) A local area network environment for information transmission and data sharing between relevant departments and positions;

(5) Application software and related databases that meet the requirements;

(6) Terminal equipment and ancillary devices capable of recording operations;

(7) Operation manuals, drawings and other technical data of the supporting system.


2, the use of electronic records of the computer (chemical) system should meet at least the following functional requirements:

(1) to ensure the authenticity, accuracy and consistency of the recording time and the system time;

(2) It can display all the data recorded electronically, and the generated data can be read and printed;

(3) The data generated by the system should be backed up regularly, the backup and recovery process must be verified, and the backup and deletion of data should be recorded accordingly;

(4) When the system is changed, upgraded or decommissioned, measures shall be taken to ensure that the original system data can be consulted and traced within the prescribed retention period.


3. Electronic records shall implement operation authority and user login management, including at least:

(1) Establish different permissions for operation and system management, and the user permissions of the business process owner shall match the responsibilities assumed, and shall not be granted the permissions of the administrator of his system (including operating system, application, database, etc.);

(2) It has the function of setting and assigning user rights, and can track and query permission modification;

(3) Ensure the uniqueness and traceability of logged-in users, and when electronic signatures are used, they should comply with the relevant provisions of the the People's Republic of China Electronic Signature Law;

(4) Information related to the operation of the system shall be recorded, including at least:

Operator, operation time, operation process and operation reason;

Generation, modification, deletion, reprocessing, renaming and transfer of data;

Changes or modifications to the settings, configurations, parameters, and timestamps of the computerized system.


Example: Modification of electronic records

For the modification of electronic records, the system needs to record the modification person (operator), the modification time (operation time), and the data before and after the modification (modification process).


4、Computer (chemical) system verification projects using electronic records should determine the scope and degree of verification based on multiple factors such as the system's infrastructure, system functions and business functions, and the maturity and complexity of the system to ensure that the system functions meet the intended purpose.



Common Requirements for Data Management


1, for the activities of the basic information data and through the operation, inspection, check, manual calculation and other acts generated.Behavioral activity data shall be specified in the relevant operating procedures and management systems to record personnel, time and content, as well as the requirements for confirmation and review methods.


2. If data is read from measuring instruments, the measuring instruments shall be verified or calibrated in accordance with the law.


3. Necessary management measures and technical means shall be taken for the electronic data collected, processed and reported by the computer (chemical) system:

(1) The electronic data obtained by manual input and processing by the application software shall prevent the software functions and settings from being changed at will, and the input data and the data generated by the system shall be reviewed, and the original data shall be preserved in accordance with the relevant provisions;

(2) The electronic data collected and processed by the computer (chemical) system shall comply with the corresponding specification requirements, and the metadata shall be saved and backed up, and the backup and recovery process must be verified.


3. Other types of data refer to data contained in the form of documents, images, audio, pictures, maps, etc. The following conditions are required:

(1) Be able to effectively represent the content contained and be readily accessible;

(2) If the data form is converted, it shall be ensured that the converted data is consistent with the original data.