The stringency of data often stems from its importance. When this data concerns lives, its importance must be elevated to the highest level. The pharmaceutical industry is a typical example, where the stringency of compliance is unimaginable. Market irregularities such as Changsheng Bio, which was heavily penalized and forced to delist in 2018, and vaccine incidents that have occurred in various regions highlight the crucial role of data supervision in production.
Overall, the pharmaceutical industry's requirements for data manifest in several aspects:
To ensure safe drug production, the operation and management of the entire pharmaceutical equipment must be monitored, and tamper-proof quality traceability data must be obtained. The pharmaceutical industry has therefore imposed stringent regulatory certification requirements, such as FDA Gamp certification. 21 CFR has been used since 1997 to regulate the pharmaceutical manufacturing process, including pharmaceutical machinery and process monitoring. This includes the management of electronic signatures and audit trails.
B&R provides support capabilities for electronic data reporting in the pharmaceutical industry at both the machine and plant levels.
MAP is a reusable software module developed by B&R based on the concept of software reuse. It includes machine motion control, process library, and other special application function modules for specific industries, such as mpUser and mpAudit, which are designed for the pharmaceutical industry. These functions are application software that are consistent with 21 CFR Part 11, and also include LDAP.
Figure 1 - mpUser's development interface
Figure 1 shows the mpUser page development. Pharmaceutical machinery manufacturers can develop user and authorization control-related functions in a very simple way. The mapp development interface is mainly based on "configuration" rather than programming, which is very easy for machine development engineers to use.
For example: Does 21 CFR Part 11.10(d) restrict system logins to authorized individuals only? mpUser is only allowed to log in to the HMI if the login data is correct.
Figure 2 - mpAudit Processing Summary
Figure 2 is a summary of mpAudit processing in mapp. User login (mpUser function development), as well as operations and value changes (mpAuditValueChange, mpAuditStringChange) performed on the machine HMI, are all recorded in mpAuditTrail, so that they can be recorded and traced.
For example: 21 CFR Part 11.10(a) Clause 2 "Is it possible to identify invalid or altered records?" All relevant operational inputs are recorded in the audit trail by date, timestamp, action, and new/old logs. When creating application software, the reliable mpAudit function block must be enabled. In addition to user input during operation, application developers also generate definite results and data, which are recorded in the audit trail. When mpUser is used, unauthorized changes will be prevented.
In addition to providing FDA Gamp-certified mapp functionality for machine developers, B&R's APROL factory data acquisition system platform can also achieve electronic signature authentication, meeting the pharmaceutical industry's needs for data security and verification.
With B&R's APROL process control system, all configurations, operations, and modifications can be seamlessly tracked. The use of electronic signatures in security reports prevents tampering with logs and process document signatures. This intuitive and convenient workflow is exactly what B&R's customers expect.
For example, according to 21 CFR Part 11.10(b) Clause 1, “Can the system generate paper and correct, complete electronic copies of the records?” mpAudit can securely export data in various formats, such as encrypted Zip files (256), XML and CSV files, and can generate PDF reports with electronic signatures. The PDF files are encrypted and cannot be tampered with using editing software.
Because the digital signature functionality in APROL is fully integrated, there is no need to generate additional certificates or use third-party software. Furthermore, users can enjoy seamless security against log tampering without any additional cost.
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