Management system for audit trail

Abstract

To provide a management system for an audit trail that can verify a validity of an audit trail based on a positional relationship between a location of a processing device and a location of an input device where an operation is performed to advance a step of a control program in a manufacturing facility for a pharmaceutical, beverage, or food product.SOLUTION: A PLC 10 allows an operator to advance a step of a control program to a next step through an operation on a touch panel 20; an audit trail recording unit 40 records, as an audit trail, first positional information indicating the position of the touch panel 20 where the operation for proceeding to the next step is input, and second positional information representing a position of a processing device such as a tank 2, which was a controlled object in the previous step; and a validity verification unit 50 determines, from the first positional information and second positional information contained in the audit trail, that the audit trail is valid if the position of the touch panel 20 where the operation was performed and the position of the tank 2 are within a predetermined range.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to an audit trail management system capable of managing the validity of audit trails in facilities for manufacturing medicines, beverages, or foods. [Background technology]

[0002] Pharmaceutical manufacturing facilities are equipped with processing equipment for various processing purposes, sensors that acquire operation data of the processing equipment, and control devices for controlling the processing equipment. The control devices run control programs to operate the various processing equipment and manufacture the desired pharmaceuticals.

[0003] The control program consists of multiple steps for implementing the manufacturing process, and some of these steps are designed to proceed to the next step by the operator's operation. For example, the control program progresses each step for implementing the process of feeding raw materials and the mixing process as follows: Raw material input process Step 1: Information to input raw materials into a tank (an example of a processing device) is displayed on an input / output device such as a touch panel. Raw material input process Step 2: When the worker has actually finished inputting the raw materials, GUI components such as buttons to be pressed are displayed on the I / O device. Raw material input process Step 3: When the worker presses the button, the raw material input process ends and the process moves on to the next mixing process.

[0004] In facilities where such steps are performed, operation data of the processing equipment and work data showing the execution status of each step are recorded. The operation data and work data are called audit trails. Audit trails serve to prove that no falsification or unauthorized manipulation of drug-related data has occurred during the steps of manufacturing pharmaceuticals.

[0005] The control device and the touch panel can be connected to each other via a network. For reasons such as equipment configuration and maintenance work, it may be possible to input the above-mentioned 2 from a touch panel located not only near the processing device but also from a touch panel located far away. In equipment using such a control device and touch panel, for example, an operator performs an operation to put raw materials into a tank located on the first floor, and performs the above-mentioned operation 2 on a touch panel located on the second floor. In this case, even if there is no problem with the quality of the product, it may be considered that the operation deviates from the defined standard operation (hereinafter, standard operation) and is not performed appropriately.

[0006] Even if the manufacturing process appears to be proceeding normally, deviations from standard work must be identified from the perspective of manufacturing management.Conventionally, management systems have been proposed that verify whether appropriate work is being performed, in other words, whether the audit trail that records the work is appropriate (see Patent Document 1), but they do not verify the validity of the audit trail by taking into account the positional relationship between the location of the processing device that is the subject of the work and the location of the touch panel where operations are performed to advance the steps of the control program. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] JP 2020-194452 A Summary of the Invention [Problem to be solved by the invention]

[0008] In view of the above circumstances, the present invention aims to provide an audit trail management system in a pharmaceutical, beverage or food manufacturing facility that can verify the validity of an audit trail based on the positional relationship between the location of a processing device and the location of an input device where operations are performed to advance the steps of a control program. [Means for solving the problem]

[0009] An embodiment for achieving the above object is an audit trail management system comprising a processing device for manufacturing pharmaceuticals, beverages or foods, a control device for controlling the processing device by executing a control program consisting of a plurality of steps, an input device capable of inputting data into the control device, an audit trail recording means for recording an audit trail, and a validity verification means for verifying the validity of the audit trail, wherein the control device is capable of advancing to the next step of the control program by an operator's operation via the input device, and the audit trail recording means records, as an audit trail, first position information representing the position of the processing device that was the object of control in the previous step and second position information representing the position of the input device where an operation to proceed to the next step was input when one of the steps (hereinafter, the previous step) is completed and the next step (hereinafter, the next step) is executed by the operation, and the validity verification means determines that the audit trail is valid from the first position information and the second position information included in the audit trail if the position of the input device where the operation was performed and the position of the processing device are within a predetermined range. Effect of the Invention

[0010] According to the present invention, there is provided an audit trail management system in a pharmaceutical, beverage or food manufacturing facility that can verify the validity of an audit trail based on the positional relationship between the location of a processing device and the location of an input device that is scanned to advance the steps of a control program. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic diagram of an audit trail management system. [Diagram 2] FIG. 2 is a block diagram showing the functions of an audit trail management system. [Diagram 3] FIG. 4 illustrates an example of a control program. [Figure 4] FIG. 13 illustrates an example of an audit trail. [Diagram 5] FIG. 13 illustrates an example of an audit trail. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Fig. 1 is a schematic diagram of an audit trail management system 1. The management system 1 of this embodiment targets a pharmaceutical manufacturing facility. The facility is composed of various processing devices for manufacturing pharmaceuticals and measuring devices for measuring operation data from the processing devices.

[0013] The tank 2 is a device that receives raw materials from an inlet of the tank 2 and stores the raw materials therein. Various devices, such as an agitator 3, a cooling device 4, a liquid delivery device 5, and a cleaning device 6, are provided in or connected to the tank 2. The tank 2, the agitator 3, the cooling device 4, the cleaning device 6, and the liquid delivery device 5 are examples of processing devices, and are collectively referred to as processing devices 2 to 6.

[0014] The agitator 3 rotates a screw disposed inside the tank 2 to agitate the raw materials. The agitator 3 is given the rotation speed and rotation time of the screw when agitating the raw materials inside the tank 2 as a control signal from the PLC 10. The agitator 3 is configured to receive the control signal and agitate the raw materials inside the tank 2 at the set rotation speed and rotation time. Information from the agitator 3, such as the actual rotation speed and the time elapsed since the start of rotation, is sent to the PLC 10, and the PLC 10 is able to read this information.

[0015] The cooling device 4 is a device for lowering the temperature of the raw materials stored inside the tank 2. The cooling device 4 cools the raw materials to a temperature given by the PLC.

[0016] The liquid delivery device 5 is a device for transferring the raw material stored in the tank 2 to another processing device (not shown). For example, it is a pump that supplies compressed air into the tank 2, and a valve provided in a pipe through which the air flows. The liquid delivery device 5 is given the pump output, the valve opening, and the like as control signals from the PLC 10. The liquid delivery device 5 is configured to receive the control signal, operate the pump at the set output, and open the valve at the set opening.

[0017] The cleaning device 6 supplies water and cleaning liquid to the tank 2 to clean the tank 2 and various devices such as piping connected thereto. The amount of water and cleaning liquid to be supplied to the tank 2, the cleaning time, and the like are given to the cleaning device 6 as control signals from the PLC 10. The cleaning device 6 is configured to receive the control signals and clean the inside of the tank 2 with a set amount of water for a set cleaning time. Information from the cleaning device 6, such as the amount of water and cleaning liquid, and the time elapsed since cleaning started, is also sent to the PLC 10, and the PLC 10 is able to read that information.

[0018] The temperature sensor 7 and the weighing device 8 are examples of measuring devices, and are collectively referred to as the measuring devices 7-8. The temperature sensor 7 measures the temperature of the raw materials stored inside the tank 2. That is, it is configured to measure the temperature of the raw materials inside the tank 2 and transmit the temperature to the PLC 10. The weighing device 8 measures the raw materials stored inside. That is, it is configured to measure the weight of the raw materials inside the tank 2 and transmit the weight to the PLC 10.

[0019] The raw materials are mixed in the tank 2 by the operation of these processing devices 2 to 6, and the raw materials are subjected to predetermined processing in other processing devices (not shown), so that a pharmaceutical product is manufactured by the entire facility.

[0020] As shown in FIG. 2, the management system 1 includes a PLC 10 and a touch panel 20 as a control device for the facility including such processing devices 2 to 6 and various measuring devices 7 to 8.

[0021] The PLC 10 is a device also called a programmable controller or sequencer. The PLC 10 includes a CPU 11 and a memory 12, and reads and executes a control program stored in the memory to control the processing devices 2 to 6. The control program reads setting values ​​for controlling the processing devices 2 to 6 from the memory, and controls the processing devices 2 to 6 to operate according to the setting values.

[0022] The touch panel 20 is connected to the PLC 10, and displays a predetermined screen and detects operations by an operator. Specifically, the touch panel 20 includes a CPU 21, an input / output unit 22, and a memory 23. The touch panel 20 is connectable to the PLC 10 via a network.

[0023] The management system 1 of this embodiment is equipped with two touch panels 20A and 20B. When there is no need to distinguish between them, they are referred to as touch panels 20. The touch panel 20A is disposed near the tank 2, and the touch panel 20B is disposed far away from the tank 2. Of course, the number of touch panels 20 is not limited to two, and the management system 1 may be equipped with two or more touch panels 20, and there is no limitation on the arrangement of the touch panels 20.

[0024] The touch panel 20 is capable of transmitting and receiving data to and from the PLC 10 via the network. The PLC 10 is capable of displaying a screen on each touch panel 20, and each touch panel 20 is capable of transmitting to the PLC 10 data such as operation of a GUI component such as a button, and data such as characters and numbers generated by operating the GUI component.

[0025] Specifically, the input / output unit 22 is composed of a display device and a detection mechanism for detecting an operation of touching the surface of the display device. The display device may be a known display device such as a liquid crystal panel or an organic electroluminescence (EL) display. The detection mechanism may be a known one such as a resistive film type or a capacitive type.

[0026] A program for operating the touch panel 20 is stored in the memory 23, and the CPU 21 calls up and executes this program from the memory 23. The touch panel 20 is also capable of reading and writing to the memory 12 of the PLC 10. Therefore, the program of the touch panel 20 is capable of displaying setting values ​​stored in the PLC 10 on the input / output unit 22, and writing new setting values ​​changed based on the operation of the input / output unit 22 to the memory 12 of the PLC 10.

[0027] In addition, in the PLC 10, a control program 30, an audit trail recording unit 40, a validity verification unit 50, and an audit trail 60 are stored in the memory 12.

[0028] An example of a control program is shown in FIG. 3. The control program 30 is a program for operating the processing devices 2 to 6 to manufacture a product. The control program 30 is written in a language such as ladder circuit. The control program 30 is made up of a plurality of steps and is executed sequentially, but some steps can proceed to the next step depending on an operation performed by an operator on the touch panel 20. The step that proceeds to the next step upon such an operation by an operator is called a confirmation step.

[0029] Steps [1] to [3] are steps to realize one manufacturing process called the “raw material input process.” Step [1]: Information encouraging the input of raw materials is displayed on the touch panel 20. The worker looks at the information and actually inputs the raw materials into the tank 2.

[0030] Step [2]: This is a step for confirming the weight of the raw materials put into tank 2. Specifically, control program 30 displays on touch panel 20 a screen on which the weight of the raw materials put into tank 2 obtained by weighing device 8 and a button to be pressed if the weight is within specifications are arranged. When the button is pressed by the worker, control program 30 proceeds to the next step [3]. Step [2] is one of the confirmation steps that proceeds to the next step [3] if an operator operates it.

[0031] Step [3]: This step is for confirming that the raw material input has been completed. Specifically, the control program 30 displays on the touch panel 20 a screen with a button to be pressed when the raw material input has been completed. When the button is pressed by the operator, the control program 30 proceeds to the next step [4]. Step [3] is one of the confirmation steps.

[0032] Steps [4] to [6] are steps for realizing a manufacturing process called the "mixing process."

[0033] Step [4]: ​​This is a step for confirming the settings related to mixing, such as the rotation speed (rpm) of the mixing device 3 and the mixing time. Specifically, a screen is displayed on the touch panel 20 showing the settings related to mixing and a button to be pressed if the settings are as specified. When the button is pressed by the operator, the control program 30 proceeds to the next step [4]. Step [4] is one of the confirmation steps that proceeds to the next step [5] if an operator operates it.

[0034] Step [5]: This is a step for making the agitator 3 agitate the inside of the tank 2. Specifically, the agitator 3 is operated by executing a predetermined command based on a set value.

[0035] Step [6]: This step is for confirming that mixing has been completed. Specifically, the control program 30 displays on the touch panel 20 a screen with a button to be pressed once mixing has been completed. The worker checks the state of the ingredients after mixing, for example by visual inspection, and presses the button. When the worker presses the button, the control program 30 proceeds to the next step [7]. Step [6] is one of the confirmation steps.

[0036] Steps [7] and [8] are steps to realize a manufacturing process called the "cooling process." Step [7]: This is a step of causing the cooling device 4 to cool the raw material in the tank 2 to a predetermined temperature. Specifically, the cooling device 4 is operated by executing a predetermined command based on a set value.

[0037] Step [8]: This is a step for determining whether cooling is complete. Specifically, the control program 30 determines that cooling is complete when a predetermined condition is met after cooling has started. The predetermined condition is, for example, the time since cooling started, or whether the temperature of the raw material in the tank 2 measured by the temperature sensor 7 has reached a predetermined temperature. When cooling is complete, the process proceeds to the next step [9]. This type of step is not a confirmation step, because the process proceeds to the next step regardless of the operator's operation on the touch panel 20.

[0038] Steps [9] to

[10] are steps for realizing a manufacturing process called the "transfer process."

[0039] Step [9]: This is a step of controlling the liquid delivery device 5 to transfer the raw material in the tank 2 to another processing device.

[0040] Step

[10] : This step is for determining whether the transfer is complete. Specifically, the control program 30 determines that the transfer is complete when a predetermined condition is met after the transfer starts. The predetermined condition is, for example, the time since the transfer started, or whether the weight of the raw material in the tank 2 measured by the weighing device 8 has become zero. When the transfer is complete, the process proceeds to the next step

[11] . This type of step is not a confirmation step, because the process proceeds to the next step without the operator's operation on the touch panel 20.

[0041] Steps

[11] and

[12] are steps for implementing a manufacturing process called the "cleaning process."

[0042] Step

[11] : This is a step for controlling the cleaning device 6 that cleans the inside of the tank 2.

[0043] Step

[12] : This is a step for determining whether cleaning is complete. Specifically, the control program 30 determines that cleaning is complete when a predetermined condition is met after cleaning starts. The predetermined condition is, for example, the time since cleaning started. When cleaning is completed, the series of manufacturing processes in the tank 2 ends.

[0044] The audit trail recording unit 40 records the operation data and the work data as an audit trail in the memory 12. Specifically, the audit trail recording unit 40 is a program executed by the PLC 10, which obtains operation data from the measuring devices 7-8, records the data together with the time of acquisition in the memory 12, and records work data performed by an operator in the memory 12.

[0045] The operating data is data obtained from the measuring devices 7 to 8. The PLC 10 executes the control program as described above to operate the processing devices 2 to 6 and manufacture pharmaceuticals, and during this time, the weight and temperature of the raw materials in the tank 2 are obtained from the measuring devices 7 to 8 as operating data.

[0046] The work data is data that represents the execution status of steps that constitute a manufacturing process. Specifically, the work data includes the date and time, data for identifying processing equipment, and data representing the executed steps. For steps that require operator operation, the work data also includes data for identifying the operator who performed the work and data for identifying the touch panel 20 that the operator operated to proceed to the next step.

[0047] The data for identifying the processing device (hereinafter, first identification data) is an ID or a name for identifying the processing device, and is further associated with first location information indicating the location of the processing device.

[0048] The data for identifying touch panel 20 (hereinafter, second identification data) is an ID, a name, or the like for identifying touch panel 20, and is further associated with second position information that indicates the position of touch panel 20. Table 1 shows an example of the association between the first identification data / second identification data and the first position information / second position information. [Table 1]

[0049] For example, the first identification data is named "Tank 2" and is associated with "1st floor" as the first location information. The second identification data is named "Touch Panel 20A" and "Touch Panel 20B" and is associated with "1st floor - in front of Tank 2" and "2nd floor - control room" as the second location information. The associated data such as those in Table 1 are pre-recorded in the memory 12.

[0050] In this embodiment, the audit trail recording unit 40 is executed by the PLC 10 and records the audit trail in the memory 12 of the PLC 10, but is not limited to this. For example, instead of recording the audit trail in the memory 12, the audit trail may be transmitted to a general personal computer or the like via a communication means, and the audit trail may be recorded on the personal computer. Alternatively, the audit trail recording unit 40 may be a general personal computer, and may be configured to obtain operation data from the measuring devices 7-8 and operation data from the PLC 10 using a communication means, and record them as an audit trail.

[0051] Figure 4 shows an example of work data in an audit trail. Each line represents a work data that is an audit trail. The audit trail in the Nth line is denoted as audit trail [N].

[0052] Audit trails [1], [5], and [7] through

[12] indicate that step 1, step 5, and steps 7 through 12 were executed by PLC 10, and that the work data, including the date and time when those steps were completed, was recorded as an audit trail.

[0053] Audit trail [2] represents the work data related to step 2. After worker A adds the raw materials, he checks the weight of the raw materials in tank 2, and when he performs the operation of checking the weight on touch panel 20A, the process proceeds from step 2 to step 3. Step 2 and step 3 correspond to the "previous step" and "next step" respectively in the claims. Audit trail recording unit 40 records "worker A" who added the raw materials. "Worker A" is an example of information that identifies a worker, and is information that can be obtained by authenticating the worker prior to operating touch panel 20A.

[0054] In addition, the audit trail recording unit 40 "Tank 2" which was the control target in step 2 (previous step) as the first specific data "1st floor" which is the first location information corresponding to the first specific data "Touch panel 20A" where an operation (such as pressing a button displayed on touch panel 20A) was performed to proceed to step 3 (next step) as the second specific data - The second location information corresponding to the second specific data is "1st floor - in front of the tank" is recorded as an audit trail (work data).

[0055] The first specified data can be obtained by previously recording each step in memory 12 in association with the processing device that the step controls, and by referring to the record. Also, data that an operator has operated touch panel 20A is sent from touch panel 20A to PLC 10, so that PLC 10 can use the source "touch panel 20A" as the second specified data.

[0056] In this way, audit trail [2] shows that "Worker A" performed work on "Tank 2" (adding ingredients and checking the weight) and performed an operation on "Touch Panel 20A" to proceed to the next step 3. The same is true for audit trails [3][4][6].

[0057] Audit trail [3] represents the work data related to step 3. When Worker A performs an operation on touch panel 20A to complete the loading of raw materials, the process proceeds from step 3 to step 4. At this time, audit trail recording unit 40 records "Worker A" who loaded the raw materials. In addition, audit trail recording unit 40 records "Tank 2", the object on which Worker A worked, as first specific data, and records "Touch panel 20A", where the operation of checking the weight was performed, as second specific data. In other words, audit trail [3] represents that "Worker A" worked on "Tank 2" (completion of raw material loading) and performed an operation on "Touch panel 20A" to proceed to the next step 4.

[0058] Audit trail [4] represents the work data related to step 4. When Worker A performs an operation of checking the set value for mixing on touch panel 20A, the process proceeds from step 4 to step 5. At this time, audit trail recording unit 40 records "Worker A" who checked the set value. In addition, audit trail recording unit 40 records "Tank 2", which is the object checked by Worker A, as first specific data, and records "Touch panel 20A", where the operation of checking the set value was performed, as second specific data. In other words, audit trail [4] represents that "Worker A" performed work on "Tank 2" (checking the set value) and performed an operation on "Touch panel 20A" to proceed to the next step 5.

[0059] Audit trail [6] represents the work data related to step 6. When Worker A performs an operation on touch panel 20B to confirm that mixing is complete, the process proceeds from step 6 to step 7. At this time, the audit trail recording unit 40 records "Worker A" who confirmed that mixing is complete. In addition, the audit trail recording unit 40 records "Tank 2", which is the object confirmed by Worker A, as the first specified data, and records "Touch panel 20B", where the operation of confirming the setting value was performed, as the second specified data. In other words, audit trail [6] represents that "Worker A" performed work on "Tank 2" (confirming that mixing is complete) and performed an operation on "Touch panel 20B" to proceed to the next step 7.

[0060] The validity verification unit 50 is a program executed by the PLC 10, which reads the audit trail from the memory 12 and verifies its validity. Of course, the validity verification unit 50 of this embodiment is not limited to this aspect. For example, the validity verification unit 50 may be a program executed on a general personal computer or the like. In this case, the validity verification unit 50 is configured to obtain the audit trail from the control device 10 using a communication means, or obtain the audit trail recorded in the personal computer, and verify it.

[0061] Specifically, the validity verification unit 50 verifies the validity of the audit trail as follows: First, the audit trail is read from the memory 12, and if the first position information and the second position information included in the audit trail indicate that the position of the touch panel 20 where the operation was performed and the position of the tank 2, which is the processing device, are within a predetermined range, the validity verification unit 50 determines that the audit trail is valid.

[0062] For example, for the audit trail [2] shown in FIG. 4, by referring to Table 1, the first location information is "1st floor" associated with the first specified data, and the second location information is "1st floor - in front of tank 2" associated with the second specified data. The predetermined range may be set arbitrarily, but it is sufficient to set it appropriately as long as it is within an allowable range of distance between the tank 2 to be worked on and the touch panel 20 to be operated. Here, the predetermined range is set to "same floor". The audit trail [2] determines that the first location information and the second location information are both "1st floor" and are on the same floor, so that they are within the predetermined range, and the audit trail [2] is determined to be valid. In other words, it can be determined from the audit trail [2] that the worker performed work on the tank 2 (adding raw materials, checking the weight) and operated the touch panel 20A located near the tank 2 to proceed to the next step, and it can be determined that the work was performed appropriately.

[0063] On the other hand, for the audit trail [6] shown in FIG. 4, by referring to Table 1, the first location information can be obtained as "1st floor" associated with the first identification data, and the second location information can be obtained as "2nd floor - control room" associated with the second identification data. The audit trail [6] determines that the first location information and the second location information are not within a predetermined range because they are not on the same floor, and determines that the audit trail [6] is invalid. In other words, it can be determined from the audit trail [6] that the worker performed work on the tank 2 (checking that mixing is complete), but operated the touch panel 20B located far from the tank 2 to proceed to the next step, and it can be determined that the work performed was not valid.

[0064] Furthermore, the validity verification unit 50 may determine whether the audit trail is valid based on whether the time between steps (hereinafter, step time) is equal to or longer than a predetermined time, in addition to the first location information and the second location information.

[0065] For example, the validity of audit trail [6] in Fig. 4 is judged as follows. First, the validity verification unit 50 calculates the step time from the completion time of step S5 (previous step) and the completion time of step S6 (next step) recorded as audit trail [6]. In this case, the step time is "5 minutes" from "9:45:00" to "9:50:00".

[0066] Next, the validity verification unit 50 determines that the audit trail [6] is valid if the first and second position information included in the audit trail [6] are outside a predetermined range and the step time is equal to or longer than a predetermined time. The predetermined time may be set arbitrarily, but it is preferable to set the time required for the worker to move from the location of the processing device (near the tank 2) where the worker is expected to be when the previous step is completed to the touch panel 20B that was operated. Here, the predetermined time is set to "3 minutes."

[0067] In this case, the validity verification unit 50 determines that the audit trail [6] is valid because the step time is equal to or longer than the predetermined time. In other words, even if the tank 2, which is the target of step 6, and the touch panel 20B, which was scanned to proceed to the next step, are far apart, the work can be determined to be valid because a sufficient amount of time has passed since the worker moved from the tank 2 to the touch panel 20B.

[0068] On the other hand, if the step time for the audit trail in Figure 4 [6] is "1 minute," it would normally take "3 minutes," but since the time it took for the worker to move from tank 2 to touch panel 20B was too short, it can be determined that the work being performed was inappropriate.

[0069] Furthermore, the validity verification unit 50 may use a different predetermined range and a different predetermined time for each operation mode. Specifically, the equipment can operate in a plurality of operation modes, and the control program 30 executed by the PLC 10 has a plurality of operation modes. That is, the equipment consisting of the processing devices 2 to 6 and the like can operate differently depending on the purpose even if the device configuration is the same. The operation modes include a normal operation mode, a cleaning mode, a maintenance mode, and the like. The normal operation mode is an operation mode for manufacturing pharmaceuticals, the cleaning mode is an operation mode for performing CIP / SIP on the various processing devices 2 to 6, and the maintenance mode is a mode for performing maintenance on the various processing devices 2 to 6.

[0070] The memory 12 of the PLC 10 is preset with a different predetermined range and a different predetermined time for each operation mode. The validity verification unit 50 then reads out the predetermined range and the predetermined time set for each operation mode and performs the above-mentioned validity verification. As a result, even if the audit trail obtained in the normal operation mode and the audit trail obtained in the maintenance mode are the same, the judgment of validity can be made differently because the predetermined range and the predetermined time that serve as the judgment criteria are different. This allows the validity to be flexibly judged according to the operation mode.

[0071] Furthermore, the validity verification unit 50 may use a predetermined range set according to the reason included in the audit trail. Specifically, the management system 1 includes a reason acquisition means (not shown). The reason acquisition means in this embodiment is implemented as part of a program executed by the touch panel 20. Of course, it may also be implemented as part of a control program executed by the PLC 10.

[0072] The reason acquisition means realizes in the touch panel 20 a function of displaying a reason input screen for inputting a reason indicating why the worker performed the work performed when executing a step. Specifically, the reason acquisition means causes the input / output unit 22 to display a screen consisting of GUI components for selecting from a plurality of predefined reasons. Then, the reason acquisition means stores the reason selected by the worker in the memory 12. The reasons stored in the memory 12 are transmitted to the PLC 10 when each step is executed, and are stored as an audit trail (work data).

[0073] Figure 5 shows an example of an audit trail that includes a reason. In this example, let's say that in addition to adding raw materials in step 1, additional raw materials were added temporarily. When the worker performs the operation in step 3 to proceed to step 4 (the next step), he or she selects "temporary additional input" as the reason. As a result, the audit trail [3] will include the reason.

[0074] The validity verification unit 50 normally uses "same floor" as the specified range, but instead uses a different specified range that is set in advance depending on the reason. For example, the specified range set in response to "temporary additional input" is "one floor difference." This means that the specified range is the same floor or one floor difference. In the audit trail [3] of FIG. 5, the first location information is "first floor" and the second location information is "second floor," but since it is within the specified range of "one floor difference," it is determined to be valid. Even if irregular work is performed in this way, it can be determined to be valid by changing the specified range if there is a valid reason.

[0075] As described above, the management system 1 of this embodiment records the audit trail of the facility and verifies the validity of the audit trail based on the positional relationship between the location of the processing device such as the tank 2 and the location of the touch panel 20. This makes it possible to verify whether the work was performed appropriately based on the movement of the workers.

[0076] The management system 1 of this embodiment verifies validity based on whether the step time is equal to or longer than a predetermined time in addition to the positional relationship. This makes it possible to more accurately capture the movement line of the worker, thereby improving the accuracy of the validity of the audit trail.

[0077] The management system 1 of the present embodiment uses different predetermined ranges and predetermined times in accordance with the operation modes in equipment having a plurality of operation modes, and therefore can flexibly determine the validity according to the operation mode.

[0078] In the management system 1 of this embodiment, when the audit trail includes the reason for the work, a predetermined range is used according to the reason. Therefore, even if an irregular work is performed, for example, if there is a valid reason, the audit trail can be determined to be valid.

[0079] In the above-described embodiments, the management system for a pharmaceutical manufacturing facility has been described, but the present invention is not limited to this and can also be applied to a facility for manufacturing food and beverages.

[0080] Although names indicating locations such as "first floor" and "in front of the tank" are used as the first position information and the second position information, the present invention is not limited thereto. For example, the first position information and the second position information may be two-dimensional coordinates or three-dimensional coordinates when viewed in a plan view. Although the predetermined range is a condition based on the structure of the equipment such as the same floor and one floor difference, the present invention is not limited thereto. For example, data indicating whether or not all combinations of the processing device and the touch panel are included in the predetermined range may be defined, and whether or not the combination is included in the predetermined range may be determined by referring to the data. Furthermore, when the first position information and the second position information are expressed by coordinates, the predetermined range may be expressed by distance.

[0081] The touch panel 20 is an example of an input device in the claims, but is not limited to this. Any device that can be connected to the PLC 10 and can input data may be used as the input device, and a keyboard, mouse, etc. may also be used. [Explanation of symbols]

[0082] 1... management system, 10... PLC (control device), 20... touch panel, 30... control program, 40... audit trail recording unit (audit trail recording means), 50... validity verification unit (validity verification means)

Claims

1. A processing device for producing a pharmaceutical product, beverage, or food product; A control device that controls the processing device by executing a control program consisting of a plurality of steps; an input device capable of inputting data to the control device; an audit trail recording means for recording an audit trail; A validity verification means for verifying the validity of the audit trail, the control device is capable of advancing the step of the control program to the next step by an operation by an operator via the input device, The audit trail recording means performs the following operation before executing the next step (hereinafter, the next step) after completing one of the steps (hereinafter, the previous step): First position information representing a position of the processing device that was the control target in the previous step; second position information representing a position of the input device at which an operation for proceeding to the next step is input; is recorded as an audit trail, The validity verification means determines that the audit trail is valid if a position of the input device where an operation was performed and a position of the processing device are within a predetermined range based on the first position information and the second position information included in the audit trail.

1. An audit trail management system comprising:

2. 2. The audit trail management system according to claim 1, When the previous step is completed and the next step is executed by the operation, the audit trail recording means recording a step time, which is the time between the completion of the previous step and the completion of the next step, as an audit trail; The validity verification means determines that the audit trail is valid if, based on the first position information and the second position information included in the audit trail, the position of the input device where the operation was performed and the position of the processing device are outside a predetermined range and the step time is equal to or longer than a predetermined time.

1. An audit trail management system comprising:

3. 2. The audit trail management system according to claim 1, The control program has a plurality of operation modes, The validity verification means uses the predetermined range that differs for each operation mode.

1. An audit trail management system comprising:

4. 3. The audit trail management system according to claim 2, The control program has a plurality of operation modes, The validity verification means uses the predetermined time period that differs for each operation mode.

1. An audit trail management system comprising:

5. 5. The audit trail management system according to claim 1, a reason acquisition means for displaying a reason input screen on the input device for inputting a reason for executing the operation, and acquiring a reason input via the reason input screen, the audit trail recording means records the reason acquired by the reason acquisition means when the step is completed as an audit trail; The validity verification means uses the predetermined range set according to the reason.

1. An audit trail management system comprising:

Images