Bubble point filter membrane online integrity tester

Bubble point filter membrane online integrity testerA. Class B data is directly read or printed, and there is a certain and simple linear relationship between the "recorded" data and the real measured object. By relying on the recorded data, it can be directly traced back to the original data and the real state.

The data generated by Class C does not contain "dynamic data or implicit information", and can be traced and restored to the original data and true state through elements such as "printed record data" and "related instrument parameters, calculation formulas".

The data generated by Class D contains "dynamic data or implicit information", which exists in database format as dynamic electronic data. It is impossible to trace and restore the original data and information solely based on paper printed records, graph curves, and parameters of related instruments.

Based on the above analysis, theoretically, only Class D needs to have "electronic data" saved. Only when electronic data is saved will the "audit trail function" for data integrity requirements be considered. That is to say, Class A manual reading and filling of paper records, Class B and C automatic printing of paper records, and Class D must have electronic data storage.

Class A

Class A, suitable for manual reading and recording of "non continuous data" in "simple, non configurable systems". Read and record at once, record at once, or read and record periodically. For example, data recording of scales, scales, temperature, humidity, handheld tools, etc.

Class B

Class B is suitable for automated recording and printing of "continuous data" for "simple, non configurable systems", such as "continuous online monitoring data (clean room temperature and humidity records, water system online records, sterilization temperature and pressure records...).

Class C

Class C is suitable for automated acquisition and printing of records for most "configurable systems" that do not contain "dynamic data or implicit information" data. For example, most production process control equipment and most inspection and testing equipment.

Class D

Class D is suitable for storage management of data containing "dynamic data or implicit information" in most "configurable systems".

In other words, pure GMP management computers, ERP management computers, warehouse material management computers, and personal computers used for production quality activities should all be electronic data storage, paper printing, and have audit tracking functions. All generated data records cannot be directly used as original records.

A-class "fraud" is simple, just intentionally filling in errors manually.

Class B "fraud" is subject to certain restrictions as it is a non configurable system. Thank you for choosing Beiguang Precision Instrument. It is our great honor to have you as our customer. Our company not only provides you with high-quality products, but also offers you satisfactory services! In order for you to use this experimental instrument more proficiently, we have randomly provided this manual.

This manual mainly introduces the knowledge related to the structural principles, operating methods, and safety precautions of this equipment.

Special reminder: Sometimes, in order to improve the performance of the device, we may make some modifications to the software or mechanical parts, which may result in inconsistencies between the operating system and the user manual in certain details. Hereby declare: The random instruction manual of the equipment you purchased is subject to the actual equipment of the testing instrument. When writing this manual, we inevitably have errors and omissions. Please forgive us and warmly welcome your valuable opinions or suggestions.

Random file:

Randomly install the following files:

1. One copy of the user manual

2. One copy of the 'Product Factory Packing List'

3. One copy of Product Warranty Card and Certificate of Conformity

When you receive this device, please check if the above documents are complete and keep them properly.

★ Special statement: Depending on the specific requirements of the customer, please refer to the packing list for specific configurations.

This manual cannot be used as a basis for making any requests to our company. The right to interpret this manual

The filter integrity tester is suitable for conducting integrity testing on filters, determining whether the selected filter material meets the required filtration accuracy, whether the filter material is damaged, and whether the sealing of the filter is intact, in order to ensure that the filter can operate normally as required. It is a new generation of automatic filter integrity tester controlled by a microcomputer, which can directly detect the bubble point and pressure attenuation value of the filter element and membrane, as well as indirectly detect the diffusion flow and water immersion value. The instrument combines advanced testing circuits and precise algorithm software to automatically test the integrity of the filter, with high testing accuracy and good reproducibility. The tester adopts a 5.7 "backlit digital LCD display screen; Chinese menu and prompts, real-time display of test data and curves, and printing of test results and curves for monitoring the entire testing process, helping to analyze the performance of filter membranes and filtration systems; The large capacity storage space inside the machine can store 50 sets of test results and 50 sets of test parameters. The entire operation testing process for filter integrity is only conducted upstream of the filter, with no contamination downstream of the filter, especially suitable for filter detection.

This tester can be widely used in industries such as medicine, biotechnology, food and beverage, microelectronics, etc. It is also a conventional instrument for filter manufacturers to conduct filter testing.

1 Testing principle

1.1 Bubble Point Method

When the porous membrane material is wetted by a suitable wetting solution, the wetting solution fills the membrane pores and stays in the pores due to the surface tension of the liquid and the corresponding capillary tension. Adding a gas pressure difference on both sides of the filter material, in order to overcome capillary pressure and drive away the liquid in the channel, bubbles must emerge. The gas pressure difference must increase to a certain value ∆ P, which is called the bubble point. The calculation formula is shown in Equation 1. Equation 1 indicates that the smaller the aperture, the higher the bubble point, so bubble points can be used to detect the performance of the filter.

∆P=K4σ cosθ / D

(Equation 1)

Among them: ∆ P - pressure difference (dynes/cm2), bubble point value

σ - surface tension of wetting solution (dynes/cm)

Bubble point filter membrane online integrity tester

The principle of integrity refers to the ability of users, processes, or hardware components to verify the accuracy of what is being sent or transmitted,

And processes or hardware components will not be altered in any way. The purpose of integrity is to protect by preventing or detecting threats

Protect the integrity of data that may be compromised in different ways and the integrity of data related attributes.

Many open system applications have security requirements that rely on data integrity. This type of requirement can be provided, including for other security purposes

Data integrity protection in services such as authentication, access control, confidentiality, auditing, and non repudiation. What is elaborated here

Integrity is defined by the constant characteristic of a data value, which includes the notion that the data value is considered equivalent

All cases of different expressions.

Performance parameters:

The basic characteristics of the integrity testing system are that the integrity tester is a compact, user-friendly interface design and modular setup, portable instrument with a weight of only 7.0kg; easy to learn and operate; By adopting a brand new hardware circuit design and utilizing advanced digital sensor technology, the accuracy and consistency of test results have been comprehensively improved; The processor of the instrument adopts a brand new industrial grade dual core design, which ensures the safety, reliability, and speed of the instrument during use with high speed and stability, while solving the problems of instability and system vulnerability caused by the operating system; Adopting a high-definition, large-sized color touch screen design, it can input richer test information and automatically select and match detection programs that can adapt to the current filter based on different test parameters; The design adopts a simple and convenient "reservation plan", which not only improves the completeness of test parameters, but also greatly simplifies the user's operating procedures, truly achieving "one click completion"; Scientific electronic signature and user grading management facilitate the subdivision of responsibilities and prevent misoperation; Detailed test data and complete test curves enable users to comprehensively analyze various performance indicators of the tested filter, providing objective analysis reports for users;

Rich data interfaces, the instrument not only includes standard digital and analog interfaces (RS232/USB), but also can customize various industrial buses and analog control ports according to customer needs; The powerful upper computer software, customizable communication protocol, and audit tracking function provide assurance for users to achieve automated centralized control and management; Our independent R&D team can design specific solutions according to customer needs. With years of on-site experience and strong professional services, we not only ensure that customers can use the instrument with confidence, but also provide technical support for the design and configuration of their filtration systems. Six types of filter material aperture, choose as needed.

Please refer to the packing list for accessories. For any other matters not covered, please contact us and we will be happy to serve you.

C and D categories may be more prone to "fraud". In addition to the technical analysis and classification above, let's talk about the risk assessment of quality impact. In fact, computer systems have been developed for so many years, and although the technical complexity is high, the technical maturity is also high. The technical risk of computers themselves is very low. Therefore, we should focus on the "occasions in which computers are used and the functions they implement". It is necessary to conduct a risk assessment of computer systems separately from the controlled object. If the necessity is zero, then the risk assessment of computer systems is actually a risk assessment of the controlled object's "equipment systems, inspection instruments" on "drug quality attributes, key process parameters, and product release". Operating conditions: Environmental temperature:+5 ℃~+35 ℃; Relative humidity: 10-80%. Due to the use of advanced algorithms and filtering methods, the instrument has stability and reliability comparable to foreign detectors, solving the common problem of instrument instability in China. The air intake unit of the instrument adopts fully automatic digital control, greatly increasing the stability of the detection process and eliminating the original method of requiring professional personnel from domestic manufacturers to adjust the air intake knob to control the air intake speed.

Pressure holding range: 0-6000 mbar; Diffusion flow: 0-2000ml/min; Water immersion: 0-50ml/min Serial port connection method Serial port: RS232;

Application scope: Test completion and printing of test results. Capsule filter power requirements/power 170-240V AC, 50/60Hz; 110W Mini cartridge water immersion test: (set test time+5 minutes) ± 2 minutes; In 1992, Sartoris proposed a method for online integrity testing of hydrophobic filters, called WIT. WIT measures the rate of decrease in air pressure upstream of a submerged hydrophobic filter using water as the medium.

Test time: Net volume test: 5 minutes ± 2 minutes; Diffusion flow test: 8 minutes ± 2 minutes;

Standard cartridge: 2.5 inches to 40 inches, with 1 to 15 cores using a standardized automatic filter material wetting program: Through a standardized automatic filter material wetting program, the filter material is ensured to be wetted by liquid, and subsequent testing work is initiated without affecting the downstream sterile state, meeting the requirements of online testing.

Performance parameters: During WIT testing, the hydrophobic filter installed on the filter housing is submerged in water upstream. Under the test pressure less than the critical pressure WPP, water cannot pass through the membrane and can only penetrate into the membrane substrate, with water preferentially entering the membrane pores larger than Z. The water immersed in the membrane substrate will not mix with the water phase passing through the membrane. Immersion is an extremely slow process, and in order to obtain water at the downstream end, pressure needs to be maintained for a long time. When conducting WIT, water is injected into the filter with a filter element from upstream, so that a section of air is sealed inside the filter housing by a water column. During testing, water infiltrates or penetrates the membrane under the pressure of the test, reducing the volume and increasing the volume of air, resulting in a decrease in pressure. The fully automatic integrity tester detects the air pressure drop corresponding to the volume of water immersed in the membrane hole. Therefore, measuring the pressure drop of the air upstream of the filter within a specified time can determine the integrity of the filter. There is an empirical value correspondence between WIT method and microbial challenge test, and it has been certified by international micro institutions.

The core components of the instrument are all imported parts, and the safety of use has been carefully analyzed during the design process. On the premise of ensuring basic electrical and mechanical safety, all aspects of the operation process have been safely handled. Can achieve integrity detection of large capacity filters. Our testing equipment is specially designed for the integrity of large capacity filters, ensuring that the measurement accuracy will not decrease when measuring multi-core filters.

The ultra large capacity data storage function can store 500 sets of test results and their test curves. Start the filtration operation of the filtration system with a simple bubble point test: 10 minutes ± 2 minutes; Enhanced bubble point test: 20 minutes ± 2 minutes; Disc membrane: Various types of membranes ranging from 25mm to 300mm. Start up testing: The tester automatically performs WIT testing on air filters. 2.5 "to 40" printing function. Wide line Chinese printing, outputting test parameters, test results, and automatic printing function. Features and advantages of the instrument: Z low intake pressure of 3000 mbar. Language selection: Chinese. Open the air inlet and drain valve of the filter housing and introduce compressed air

Test accuracy net volume test: ± 4%; Bubble point: ± 50mbar; Diffusion flow: ± 4%; Water immersion method: ± 0.1ml

Simple bubble point test: 10 minutes ± 2 minutes; Enhanced bubble point test: 20 minutes ± 2 minutes;

The core components of the 7 instruments are all imported parts, and the safety of use has been carefully analyzed during the design process. On the premise of ensuring basic electrical and mechanical safety, safety measures have been taken for all aspects of the operation process.

Performance parameters: Serial port connection method Serial port: RS232;

Pressure holding range: 0-6000 mbar; Diffusion flow: 0-2000ml/min; Water immersion: 0-50ml/min

Test Range Z: Large Test Pressure: 500-6000mbar; Bubble point: 500-6000 mbar;

In 1992, Sartoris proposed a method for online integrity testing of hydrophobic filters, called WIT. WIT measures the rate of decrease in air pressure upstream of a submerged hydrophobic filter using water as the medium.

Due to the use of advanced algorithms and filtering methods, the instrument has achieved stability and reliability comparable to foreign detectors, solving the common problem of instrument instability in China. The air intake unit of the instrument adopts fully automatic digital control, greatly increasing the stability of the detection process and eliminating the original method of requiring professional personnel from domestic manufacturers to adjust the air intake knob to control the air intake speed.

Operating conditions: Environmental temperature:+5 ℃~+35 ℃; Relative humidity: 10-80%

standard functions

The integrity tester can perform the following standard functions:

1. Basic bubble point detection;

2. Manual bubble point detection;

3. Pressure holding test;

4. Diffusion flow detection (including microfiltration and ultrafiltration);

5. Enhance bubble point detection (joint testing of diffusion flow and basic bubble point);

6. Water immersion detection;

7. Self inspection;

8. Verification;

9. Support pre built 80 testing plans;

10. User grading management;

11. Use the built-in printer to print;

12. Can store 5000 test results;

13. Display time and date;

14. Support input in both Chinese and English;

15. Audit trail.

Operational requirements

1. Indoor use;

2. AC power supply: 100-240 VAC, 50HZ, 120W;

3. The fluctuation of power supply voltage cannot exceed ± 10% of the standard voltage;

4. Temperature:+5 ℃ -+40 ℃;

5. Relative humidity: 10% -80%, no condensation phenomenon;

6. Dustproof: IP42;

7. Clean, oil-free compressed air or nitrogen;

8. Compressed air or nitrogen with high working pressure<150 psi (10000 mbar);

9. Avoid strong magnetic interference. 1、 Identity verification

(1) User Management

Integration of system and identity authentication system. Use password to confirm the user's identity and perform identity authentication.

(2) Re identification

The system provides a setting function for idle operation time. When the idle operation time exceeds the specified value (usually 2 hours), it is necessary to

The user needs to re authenticate their identity.

(3) Login Failure Audit

When the number of failed attempts at user authentication reaches 5, the system locks the user and can only be restored by the administrator,

Simultaneously generate audit events and issue alerts.

Data Audit

(1) Audit scope

The system should provide audit functionality to audit the addition and deletion of users within the system, changes in user permissions, and the actions of system administrators and users

The operation of application.

(2) Audit record content

Audit records should include the following information: time, location, type, subject, object, and outcome (success or failure) of the event

To be audited regularly by the audit administrator. 3、 Audit tracking

1) Log recording

1) Log recording: Automatically record the operation records of system users, including login name, machine name (as much as possible), login time

Exit time, operation content, and other information can be summarized.

2) Log query

2) Log query: Log queries can be performed based on information such as login name, machine name, login time, exit time, and operation content.

3) Log viewing

3) Log viewing: Depending on the different permissions of the account, different accounts can only view log files within their scope of permissions

The person in charge checks the logs of department employees, and the dean checks all logs.

Wonderful historical articles

working environment

Environmental temperature: 15 ℃ to 40 ℃;

Environmental humidity: ≤ 80% RH;

Power requirements: AC220V ± 22V, 50Hz ± 1Hz;

Usage environment: Clean environment, no corrosive gases;

Bubble point method

Bubble point testing is a method based on the surface tension and capillary phenomenon of liquids in the pores of filtration membranes

Non destructive testing methods; It is an important method for detecting whether the filter membrane is complete and meets the requirements.

After the filter membrane is fully immersed, the gas in the gas phase should be adsorbed and blocked in the capillary wall

The extraction of liquid requires overcoming a certain surface tension of the liquid, which is related to the physical properties of capillary pores, the wetting angle of liquid membrane materials, and gas pressure. The formula is:

R = 2k ·δ ·cos θ/Δp

among which

R —— δ—— θ—— ∆p——

K ——

Micro pore radius;

Liquid surface tension coefficient;

The infiltration angle of liquid filter membrane material;

The net pressure exerted by gas on capillary pores;

Hole type correction coefficient.

The above expression indicates that the smaller the pore size, the higher the pressure required for the individual bubbles generated by compressed air to pass through, and the smaller the pressure required to pass through large pores, which is called the bubble point of the membrane. Based on this, the large pore size values of flat filter membranes and column filter membranes can be analyzed.

Pressure maintenance method

The pressure holding method is also known as the pressure decay test. During the testing process, a high-precision pressure gauge or high-precision pressure sensor is used to monitor the pressure changes upstream caused by leaks or gas diffusion through the filter. This test has two main purposes:

1. Used to measure the sealing performance of the filtration system;

2. Check the integrity of the filter.

On earlier versions of the machine, specialized devices and programs for measuring upstream volume were not yet used, making it impossible to achieve real-time and accurate measurement of the upstream volume of the filter, thus making it impossible to directly calculate the diffusion flow value.

Generally, measuring the pressure attenuation of the filter can also be used as an approximate alternative to the diffusion flow testing method. After a certain amount of

Time, measuring this attenuation value can determine the integrity of the filter. The calculation formula is as follows: ∆ p=D · T · Pa/V

However, due to limitations in basic theory and sensor hardware, as well as the removal of functions such as temperature compensation and volume calibration compensation, there is a significant loss in the reliability and sensitivity of the test data.

Enhanced Bubble Point Method

The enhanced bubble point method combines diffusion flow testing and bubble point testing to detect the integrity of the filtration membrane. Enhanced bubble point testing is not suitable for situations where the filtration membrane area is small or large multiple filtration systems make it impossible to measure the bubble point. Basic bubble point test: 2 minutes ± 2 minutes; Diffusion flow test for 7 ± 2 minutes; Water immersion

Flow test for 7 ± 2 minutes; System airtightness: 3 ± 1min;

Printing function in Chinese/English, printing test conditions, test results, and test curves;

History recording function with 32GB storage space, saving 1 million pieces of data

Display screen size: 5.7-7 inches; 256 colors; touch screen

Language selection: Chinese/English Disc membrane: Various types of membranes ranging from 25mm to 300mm in diameter

Standard cartridge: 2.5 "to 40", 1 core to 9 cores

Capsule filter cartridge

Mini cartridge filter

The 2.5 "to 40" integrity tester for air filters has the following characteristics compared to other domestic brands of instruments:

1. Automatic intake control

The integrity tester adopts the fully automatic digital intake control subsystem commonly used abroad, abandoning the domestic one

The later mechanical semi-automatic intake method (i.e. using manual adjustment of one-way throttle valve to change gas flow)

Speed, so that the tester can work stably and reliably under different gas source pressures and testing conditions, especially when

When the pressure fluctuation of the gas source used by the customer is relatively large, the instrument itself has automatic stabilization and digital control technology,

Ensuring the accuracy and precision of the test results.

2. Filter qualified, automatic exit function

As a consumable, filter membrane/folding filter cartridge has its own service life, but proper use can lead to

Their lifecycle is greatly extended. To protect the customer's filter membrane and improve the efficiency of production use (i.e

Shorten testing time), specifically adding the function of "automatic exit after passing the test", which is also a feature in China

The instrument that implements this function.

3. Automatic printing

Some users may have other things to deal with during integrity testing and need to leave the testing site

However, he hopes to receive the printed test results when he returns. Not because after the testing is completed,

Other unforeseeable reasons may cause the loss of test results. The tester started automatic printing when the user activated it

After selecting the option, the function of automatically printing the test results after the test is completed can be realized, which is also the implementation

This type of instrument has this function.

4. User Rating Control

As a precision testing instrument, there are many parameters that need to be set in the complete tester

Changes may affect the accuracy and reliability of test results. At the same time, in order to meet the management requirements of GMP

Please note that regular operators and managers should have their own distinct operational permissions. All versions of the series

There is a user grading management function, and I V4.0 has made it more user-friendly, allowing users to use it according to their usage situation

Changing the login password of the instrument is also the instrument that implements this function.

5. Larger data storage capacity

The integrity tester currently has a large storage capacity for test results in China, and its standard configuration is 500 sets

We can also customize the historical records (including testing conditions, test results, and test curves) according to customer requirements

Create larger storage capacity. It is possible to copy all historical data from the instrument to the computer, thus achieving

Unrestricted preservation of historical records.

6. Wide testing scope

The measurement range of the integrity tester is very wide, from flat filters to multi-core bucket filters, ranging from

Both bag filters and respirators can be tested. And the instrument itself has a high-resolution signal analysis section

The logic module ensures that errors can be minimized when measuring the integrity of large filtering area filters. With the same

When some brands conduct comparative tests with third parties, the testing instruments repeatedly measure 5-core 20 inch PES filters

When it comes to the integrity of the chip, its testing speed and consistency of test results are far superior to those of the other instrument.

7. Testing is more convenient and the human-machine interface is more user-friendly

A lot of work has been done in the aspect of human-computer interface. Firstly, there are prominent operation prompts at the bottom of each work interface

Users can complete all operation items according to the prompt content. Secondly, the instrument was designed with "post test conditions

The 'auto save' function allows users to use 'one' if they test filters of the same specifications every time

Press and hold the 'OK' button on the instrument panel after selecting a testing function, and the instrument will

Being able to perform filter integrity testing based on the parameters input during the last test greatly simplifies the process

Operating procedures for personnel.

8. It is one of the earliest instruments in China to achieve diffusion flow and water intrusion testing functions, and the water immersion testing function is no longer available

Chang has matured and its test results have high reliability.

9. Security

Safety production is an important indicator for all enterprises, and the safe operation of instruments and equipment is also a key factor in safety production

From the beginning of the design, the safety of the instrument has been considered as the fundamental performance, whether it is under pressure or not

During the testing process, security measures were taken even in standby mode. For example, the instrument is in standby mode after being powered on

In fact, it has been conducting safety self checks on the system. When it is found that the pressure inside the instrument is greater than the safety pressure, it

The air release function will automatically activate to prevent workers from operating the filter under pressure and eliminate safety hazards.

This product meets the requirements of the Pharmacopoeia issued in 2020,

Implement instrument permission management, audit tracking, and electronic signature.

And an optional database expert management system can be developed.

Product Features

High intelligence: The testing process is fully automated and does not require manual intervention;

High reliability: high detection accuracy and good reproducibility;

High humanization: touch screen input, user-friendly operation interface;

Multifunctional: Can be used to test single core filters, multi-core filters, and multiple testing functions;

High integration: The instrument adopts a portable design, small size, and easy to use;

High tech: using ARM11 controller and Windows CE 6.0 system;

High practicality: data storage, real-time printing of test results, in compliance with GMP requirements.

Application scope

Disc membrane: various types of membranes ranging from 25mm to 300mm in diameter

Standard cartridge: 2.5 "to 40", 1 core to 9 cores

Capsule filter cartridge

Mini cartridge filter

Air filter detection from 2.5 inches to 40 inches

Other parameter filter audit tracking is an audit behavior that tracks and analyzes system activity and user activity flow records, where flow records refer to events from power requirements/power 100-240V AC, 50/60Hz; 120W

High operating pressure of 10000 mbar (150psi)

Low intake pressure of 100 mbar (1.5psi)

Dimensions (mm) 400 (length) × 240 (width) × 270 (height 1) × 220 (height 2)

Test range Bubble point 100-8000mbar Diffusion flow rate 1-600ml/min Water immersion: 0.01-100ml/min

Test function

Manual bubble point test, basic bubble point test, enhanced bubble point test, pressure holding test, diffusion flow test, water immersion test;

Ultrafiltration membrane package testing

Scope of application: Symmetric/Asymmetric Membrane, Needle Filter, Capsule Filter, Flat Plate Filter, Cartridge Filter, Ultrafiltration Membrane Pack, Ultrafiltration Column

Audit tracking of multiple event logs (optional)

Permission management username and password login, with four levels of permissions, meeting FDA21 CFR PARTII requirements

120 sets of pre stored solutions

Test accuracy net volume test: ± 4%; Bubble point: ± 50mbar; Diffusion flow: ± 4%; Water immersion: ± 0.01%

Operating conditions: Environmental temperature:+5 ℃~+40 ℃; Relative humidity: 10-80%

Printing function comes with a micro printer, online PC

Record storage with no quantity limit for over 15000 sets of historical records

Record backup supports exporting data from USB flash drive

Dustproof and waterproof rating: IP65 on the front

High definition 7-inch color touchscreen display

Serial port connection method RS232; USB port

Usage: Online/Offline

Language selection: English/Chinese

Weight 8KG

Suitable for environments above level D

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 "as easy as pie", because in terms of data integrity, "power" is greater! 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.