PTFE Bubble Point Integrity Tester

PTFE Bubble Point Integrity Tester

Signal output (4-20) mA, RS485, 12V alarm output

The sequential inspection, review, and verification of the environment and activities of each event carried out through the end-to-end approach, including system activities such as operating systems and applications

The activity of program processes, including user activities within the operating system and applications.

Audit tracking provides written evidence of the activities of responsible personnel to support the implementation of audit functions, through the use of appropriate tools

By implementing regulations and procedures, audit tracking can provide early warning and prevent potential disruptors from infringing on the security of audit activities.

Performance parameters

Which equipment and instruments require 'audit tracking'?

2015 has passed, and "data integrity defects" are being hyped up in the pharmaceutical industry. Whether it is domestic or foreign, whether it is the European Union or the FDA, inspectors take pride in discovering "data integrity defects". It seems that if no "data integrity" defects are found during the inspection, inspectors will "lose face" and "have no face to see the elders of Jiangdong

What about the enterprise? Trembling and fearful, they all regarded "audit tracking" as a "life-saving straw" and "exorcism sword technique", holding money in their hands and queuing up to demand suppliers to upgrade their systems and teach martial arts. Have you ever thought about it? What is the "audit trail" function and what is the purpose of the audit trail function? With the audit tracking function, do you "no longer need" to falsify? With the audit tracking function, you can't "cheat" anymore?

The answer, of course, is NO.

Audit trail is a series of records related to computer operating systems, applications, and user operations, used to help us trace from raw data to relevant records, reports, or events, or from records, reports, events to raw data.

The audit trail in paper records must ensure that any modifications or deletions are made to the original data in a clear and readable manner, and record the personnel who made the modifications, the date of modification, and the reason for the modification. The reasons for the changes must be verified and explained as needed. This is our usual practice before!

The audit trail of electronic records should allow for the restoration or reproduction of the process of creating, modifying, and deleting electronic data related to events in both the system and records. The user ID of the original input and document, the time, date, and reason for the action should be saved.

When a computer system is used to acquire, process, report, and store raw data, the system design should provide comprehensive audit tracking functionality and be able to display all deletions and modifications made to the data. The audit tracking function should display the person who made the deletion or modification, the time of deletion or modification, and record the reasons for the deletion or modification. If necessary, the deletion or modification should be approved.

Simply put, the "audit trail function" is not used to "control" the processes of data collection, input, storage, backup, transfer, retrieval, recovery, calculation, processing, output, referencing, invalidation, modification, deletion, etc.

The audit tracking function is only a record of "data events", which can "track" "illegal activities" and quickly identify and restore "historical truth". However, it cannot effectively "control" and "reduce" the occurrence of "motivated" "activities, nor can it reduce the harm of" behavior "to" society "!

The requirements for data integrity of manual paper data and electronic data are consistent, and honest paper records are acceptable at all times. The key is how to ensure that you are honest? How to make others believe that you are honest?

Handcrafted paper records do not reduce the requirement for controlling data integrity. Paper records are more prone to fraud and have lower difficulty and cost, so we need appropriate electronic data. But electronic data is not omnipotent, and "fraudulent behavior" within the scope of authority is "easy", because in terms of data integrity, "power" is the greatest! Of course, enterprises should adopt "generally accepted scientific methods" for drug production and inspection based on the "status of scientific and technological development". We need to use advanced technological means to minimize the occurrence of "fraudulent" behavior as much as possible! However, we should focus more on how to make companies "not need" to cheat! Instead of blindly using hardware measures and technological means to restrict enterprises from "impossible" fraud, this is actually an "impossible" thing to do forever! Do all devices and instruments need to be audited and tracked?

Appendix "Computerized Systems"

Article 3: As part of quality risk management, the degree of verification and data integrity control should be determined based on written risk assessment results.

Article 16: Based on the results of risk assessment, consideration should be given to establishing a data audit tracking system in computerized systems to record the input and modification of data, as well as the use and changes of the system.

MHRA "Data Integrity Definition and Industry Guiding Principles"

The energy and resources invested in data management should be commensurate with the risk level of its products.

The degree of organizational and technical control over each element in the data lifecycle, as well as the resources invested, should be commensurate with the impact of the data on product attributes.

The basic principles for implementing data integrity are:

Determine the risk assessment based on the degree of impact on product quality attributes and key process parameters.

So, let's not talk about how to evaluate quality risks for now. Let's first classify and explain the principles of data generation and data collection:

Class A:

Simple and non configurable "instruments, online sensors, and testing tools" directly measure or display data, manually read and record it on paper media, form paper records, and can be directly archived as original records.

Class B:

Simple and non configurable "instruments, online sensors, testing tools" directly measure or display data, connect to a printer to print the data on paper media, form paper records, and can be directly archived as original records.

Class C:

General, configurable systems such as instruments, testing tools, and computer systems generate data that can be displayed through instrument parameter settings and software program calculations, and directly print it on paper media to form paper records that can be archived as original records.

Class D:

PTFE Bubble Point Integrity Tester