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1. To establish a procedures laboratory, it is necessary to create electronic record management procedures that meet the requirements of the laboratory’s quality system; the requirements outlined in these procedure documents must be specific and actionable. 2 General requirements: Electronic records must be kept in a timely manner for technical activities (no retroactive recording is allowed) ； Electronic records must ensure the integrity, completeness, and traceability of the recorded information, providing objective evidence for the experimental process. 3 Specific requirements for electronic records: 1. The laboratory must define the confidentiality levels for various types of electronic records ； 2. The retention period and storage method for electronic records need to be specified in the laboratory ； 3. Electronic records must be protected from damage and loss ； 4. Electronic storage records must be properly protected and backed up ； 5. Electronic records must be protected from unauthorized access or modification. 6. Update the storage medium used for electronic record-keeping to ensure that the stored information can be read smoothly. When modifying electronic records, the changes must be clear and explicit; arbitrary alterations are generally not allowed ； If modification is necessary, the electronic record should retain traces of the modifications, specifically by: 1. retaining the version prior to the modification ； 2. Clearly indicate the modified content ； 3. Clearly indicate the modified content ； 4. Identify who made the changes ； 5. Record the modification date