On May 11, the State Drug Administration issued the "14th Five-Year Plan" for Drug regulatory Network security and information construction, specifying the construction objectives, key tasks and safeguard measures of drug regulatory network security and information construction during the "14th Five-Year Plan" period.

The Plan proposes to build the capacity of information-based traceability. Establish and improve the drug traceability system, expand and build the drug traceability collaborative service platform and traceability supervision system, provide data support for regulatory decision-making, bring into play the role of traceability big data in daily supervision, risk prevention and control, product recall, emergency response and other work, and improve the precision level of drug supervision and whole-process governance capacity.
The quality and safety of drugs is related to the safety and health of people's lives. With the development and progress of pharmaceutical technology, laws and regulations have put forward higher requirements for the quality management in the process of drug production.
Article 7 of the General provisions of the Drug Administration Law of the People's Republic of China requires that all drug research and development, production, distribution and use activities shall be conducted in accordance with laws, regulations, rules, standards and norms to ensure that the information of the whole process is true, accurate, complete and traceable.
GMP puts forward requirements for access control system, and procedures should describe how to manage the access control system, including personnel authorization, cancellation and authorization change management, data reliability management. Monitor the reliability of access control system function regularly, such as negative test, and record. Check the personnel entry and exit records and unauthorized entry recorded by the access control system regularly.
In order to ensure the high quality of the pharmaceutical environment, it is necessary to strictly control the access and number of personnel in the clean area. However, the intelligent system management of pharmaceutical enterprises has not been popularized. At present, the personnel entry and exit control in most clean areas of pharmaceutical enterprises is mainly managed through the company system and the consciousness of employees. Manual management has many drawbacks, such as low efficiency, easy to make mistakes and difficult to query records.

To realize the traceability of data, it is necessary to rely on the means of information management. The intelligent access control system independently developed by Capalito realizes the management of the access rights of personnel in the clean area, real-time control of the number of personnel in the clean area, query of personnel access records in the clean area, and the whole-life cycle management of the cleaning and sterilization status of the clean clothing through the RFID electronic tag built into the clean clothes. System background has a powerful data storage and record function, automatic generation of reports, truly realize the management of intelligent, information and data.

Drug supervision network security and information construction is imperative, its importance is self-evident. Capelliton's intelligent access control system and intelligent clean clothes provide technical guarantee for the quality and safety of drugs in the pharmaceutical industry. In the future, Capellito will adapt to the market demand and changes, further upgrade and optimize products, continue to innovate and refine, and promote the development of intelligent information technology in the pharmaceutical industry.