The theme of this year's World Health Day is " Our Planet, Our Health ". In the current epidemic situation, as an effective measure to protect human health, how to speed up the circulation of vaccines and fight the epidemic "quickly" has become a top priority.
Recently, the Information Center of the State Drug Administration and the Center for Food and Drug Examination and Inspection publicly solicited opinions on the "Technical Guidelines for Electronic Recording of Vaccine Production Inspection (Draft for Comment)" (hereinafter referred to as "Guidelines") . Packaging, warehousing, release, quality management, data collection” and other links to deepen the application of electronic signatures , realize electronic batch records, and accelerate the information transformation of vaccine marketing license holders, especially vaccine marketing license holders, need to take the lead in realizing Electronic data conversion of vaccine production and inspection information.
The "Guidelines" clarifies that the use of electronic signatures should comply with the relevant provisions of the "Electronic Signature Law of the People's Republic of China", and use cryptographic technology to use third-party CA certificates. It also points out that reliable electronic signatures have the same legal effect as handwritten signatures or seals.
The "Guidelines" on the application of electronic signatures in all aspects of vaccine production and inspection, the specific content is as follows:
01 Vaccine production
The "Guidelines" require that electronic signatures be used to fully digitize electronic batch records .
Among them, the person in charge of the production process, the operator/reviewer of the production step, and the person controlling the results can all use electronic signatures .
In addition, after the end of production: information means should be used to record the clearing operation, and the clearing electronic records include: operation room number, product name, batch number, production process, clearing date, inspection items and results, electronic signatures of the person in charge of clearing and the reviewer .
02 Vaccine packaging
The packaging part of the electronic batch record should include the batch number and quantity of the product to be packaged, as well as the batch number and planned quantity of the finished product.
Electronic batch packaging records shall at least include the following:
In this link, the person in charge of packaging operations/operators, inspectors, and authorized personnel can all use electronic signatures .
03 Release of finished vaccine products
In the release process of finished vaccine products, production and release can be approved after the electronic signature of the relevant authorized personnel .
04 Vaccine inspection and release management
The "Guide" clarifies that the electronic inspection report with a reliable electronic signature has the same legal effect as the paper inspection report.
05 Vaccine quality document management
The "Guidelines" suggest that electronic signatures be used and dated for the drafting, revision, review and approval of documents .
06 Electronic Data Capture/Import
The "Guidelines" pointed out in the basic requirements of informatization that the key data entry personnel should sign electronically when necessary , and the electronic signature of the modifying personnel is also required when the data is modified .
This time, relevant state agencies have vigorously promoted the application of electronic signatures in vaccine production and other links, once again proving the important role played by electronic signatures in the digital transformation of the pharmaceutical industry.
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