Confidentiality in drug inspection and testing refers to the principles and measures for keeping confidential and protecting the information involved in the process of drug inspection and testing. As a crucial measure to ensure drug quality and safety, it mainly includes the following aspects:
I. Data Protection
Data generated during drug inspection and testing shall be encrypted and stored to ensure that only authorized personnel can access and use such data. Meanwhile, measures shall be taken to prevent data leakage and unauthorized access.
II. Sample Protection
Samples for drug inspection and testing shall be protected during collection, transportation, and storage to prevent them from being tampered with, contaminated, or replaced. Only authorized personnel are allowed to contact and handle the samples.
III. Information Sharing Control
The scope of sharing information involved in drug inspection and testing shall be strictly controlled, and only authorized personnel can share relevant information. Additionally, corresponding security mechanisms shall be established to ensure the safety and reliability of information sharing.
IV. Staff Confidentiality
Staff engaged in drug inspection and testing shall sign confidentiality agreements and receive relevant confidentiality training to ensure they understand and comply with confidentiality regulations. Meanwhile, a supervision mechanism shall be established to supervise and inspect the confidentiality behavior of staff.
Confidentiality in drug inspection and testing is of great significance to inspection institutions. For example, in terms of protecting enterprises' commercial interests: drug test results may involve the commercial interests of pharmaceutical manufacturers, including product quality, ingredients, efficacy, and other information. If such information is leaked, competitors may obtain commercial secrets, resulting in losses to the enterprise.
Another example is the protection of patients' privacy: drug testing may also involve patients' personal information, such as medical records and medication history. The leakage of this information may violate patients' right to privacy and even lead to the misuse of personal information. Inspection and testing institutions need to adopt a series of technical and management measures to protect the safety of relevant information and samples.
In view of the above, Beijing Sunway World Technology Co., Ltd. has independently developed the Laboratory Information Management System (SW-LIMS). In terms of product functions, it can flexibly set the display of sample information at each process node. For example, display fields can be customized in links such as sample registration and acceptance, sample retention management, task assignment, inspection and testing, review, report issuance, and report distribution.
By displaying the information fields concerned by authorized personnel at each node according to different process nodes, it can effectively ensure the confidentiality of inspection and testing data fields at different nodes. At the same time, it provides authorized personnel with quick list export and advanced query functions, facilitating them to filter, query, and export data during the approval process and improving the efficiency of inspection work.
While realizing the customized display of process node field data, SW-LIMS has also developed the "Custom Query Module" report function, providing personalized statistical analysis functions for data confidentiality at the data statistical analysis application level. System administrators can conveniently generate statistical data report menus required for business operations through this module without updating background applications, and quickly generate report menu functions through front-end page configuration.
The main features of this function are as follows:
· The fields displayed in report statistics and the settings of query conditions can be flexibly configured, improving convenience for authorized personnel to conduct data statistics.
· Menu functions are controlled by associating with roles to achieve data and permission isolation, so that different authorized personnel can focus on different information and data.
· Relevant authorized personnel can perform multi-dimensional and flexible combination of filtering conditions for data query, statistics, and analysis according to the fields assigned by authorization, enhancing the scalability of report queries.
In SW-LIMS, separating and isolating different data and permissions can effectively protect data security in the system, prevent the leakage and misuse of basic sample information and test result data, and ensure that authorized users can only access the data and functions they are authorized to use. This improves the security and credibility of the system and protects the confidentiality of sample information and data.
Through the customized data statistical analysis function module, SW-LIMS can quickly and efficiently provide the required data statistics for each authorized person, supporting business decision-making with data. SW-LIMS integrates data statistics with information confidentiality, realizing the confidentiality of data information and test results while sharing data in the information system.
SW-LIMS provides a strong guarantee for strengthening laboratory information security management, the confidentiality of drug inspection and testing, and drug quality and safety, protecting the legitimate rights and interests of pharmaceutical manufacturers and consumers. As a well-known domestic laboratory information management platform, SW-LIMS has been committed to providing customers with better services, and will continuously develop and improve product functions to bring users a better experience. We look forward to forming a strong alliance and achieving win-win cooperation with you in the future.