The present disclosure generally relates to the field of chromatography including smart audit trail review.
Chromatography can be used to separate and analyze components of a complex sample. In many industries, such as clinical labs, law enforcement labs, QA/QC labs, and the like, it may be required to maintain auditable logs to verify the validity of the analysis.
For a more complete understanding of the principles disclosed herein, and the advantages thereof, reference is now made to the following descriptions taken in conjunction with the accompanying drawings, in which:
It is to be understood that the figures are not necessarily drawn to scale, nor are the objects in the figures necessarily drawn to scale in relationship to one another. The figures are depictions that are intended to bring clarity and understanding to various embodiments of apparatuses, systems, and methods disclosed herein. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Moreover, it should be appreciated that the drawings are not intended to limit the scope of the present teachings in any way.
Disclosed herein are scientific instrument support systems, as well as related methods, computing devices, and computer-readable media. For example, in some embodiments, a scientific instrument support apparatus includes a first logic to obtain chromatography data from chromatography system; and log events of a chromatographic system including changes to instrument methods, processing methods and manual peak integration; a second logic to analyze the chromatography data; and log events of the data analysis and changes to data analysis methods; and a third logic to identify linked events in the audit logs; and providing a user interface for viewing the linked events.
The scientific instrument support embodiments disclosed herein may achieve improved performance relative to conventional approaches. Audit logs of various components and steps of the analysis can be stored in multiple locations. For example, audit logs of the performance of the scientific instrument can be separate from audit logs of the data analysis. Additionally, audit logs of changes to methodologies can be separate from both the instrument audit logs and the analysis audit logs. Further still, additional audit logs related to computer security, such as user logins and access to various data files may be further separated from the other audit logs. Logging all these data to the same location may be undesirable as different subsystems are responsible for logging different aspects of the audit logs. However, cross referencing events in one log with events in another log may be tedious and labor intensive. Automated systems that cross reference events from multiple logs can save time and avoid missing events that could impact the validity of an analysis. Additionally, enforcement of policies to ensure changes to methodologies undergo a second-eye review to catch and correct errors or prevent inadvertent changes to the methods. The second-eye review can block further use of an analysis until the second user reviews and approves the changes. Alternatively, the second-eye review can require a second user to review changes before they are implemented in the system. Generally, the same user would not be able to both initiate a change and approve the changes. In some cases, changing methods may be limited to a subset of users and a second-eye review may be required from a user in a second subset of users.
The section headings used herein are for organizational purposes only and are not to be construed as limiting the described subject matter in any way.
In the following detailed description, reference is made to the accompanying drawings that form a part hereof wherein like numerals designate like parts throughout, and in which is shown, by way of illustration, embodiments that may be practiced. It is to be understood that other embodiments may be utilized, and structural or logical changes may be made, without departing from the scope of the present disclosure. Therefore, the following detailed description is not to be taken in a limiting sense.
Various operations may be described as multiple discrete actions or operations in turn, in a manner that is most helpful in understanding the subject matter disclosed herein. However, the order of description should not be construed as to imply that these operations are necessarily order dependent. In particular, these operations may not be performed in the order of presentation. Operations described may be performed in a different order from the described embodiment. Various additional operations may be performed, and/or described operations may be omitted in additional embodiments.
For the purposes of the present disclosure, the phrases “A and/or B” and “A or B” mean (A), (B), or (A and B). For the purposes of the present disclosure, the phrases “A, B, and/or C” and “A, B, or C” mean (A), (B), (C), (A and B), (A and C), (B and C), or (A, B, and C). Although some elements may be referred to in the singular (e.g., “a processing device”), any appropriate elements may be represented by multiple instances of that element, and vice versa. For example, a set of operations described as performed by a processing device may be implemented with different ones of the operations performed by different processing devices.
The description uses the phrases “an embodiment,” “various embodiments,” and “some embodiments,” each of which may refer to one or more of the same or different embodiments. Furthermore, the terms “comprising,” “including,” “having,” and the like, as used with respect to embodiments of the present disclosure, are synonymous. When used to describe a range of dimensions, the phrase “between X and Y” represents a range that includes X and Y. As used herein, an “apparatus” may refer to any individual device or collection of devices. The drawings are not necessarily to scale.
All literature and similar materials cited in this application, including but not limited to, patents, patent applications, articles, books, treatises, and internet web pages are expressly incorporated by reference in their entirety for any purpose. Unless described otherwise, all technical and scientific terms used herein have a meaning as is commonly understood by one of ordinary skill in the art to which the various embodiments described herein belongs.
It will be appreciated that there is an implied “about” prior to the temperatures, concentrations, times, pressures, flow rates, cross-sectional areas, etc. discussed in the present teachings, such that slight and insubstantial deviations are within the scope of the present teachings. In this application, the use of the singular includes the plural unless specifically stated otherwise. Also, the use of “comprise”, “comprises”, “comprising”, “contain”, “contains”, “containing”, “include”, “includes”, and “including” are not intended to be limiting. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present teachings.
A “system” sets forth a set of components, real or abstract, comprising a whole where each component interacts with or is related to at least one other component within the whole.
Upon exiting the column 104, the compounds can enter the detector 106. Various detectors can be used as part of a chromatography system including ultraviolet/visible detectors, infrared detectors, flame ionization detectors, nitrogen phosphorous detectors, electron capture detectors, thermal conductivity detectors, flame photometric detectors, mass spectrometers, and the like.
The scientific instrument support module 1000 may include first logic 1002, second logic 1004, and third logic 1006. As used herein, the term “logic” may include an apparatus that is to perform a set of operations associated with the logic. For example, any of the logic elements included in the support module 1000 may be implemented by one or more computing devices programmed with instructions to cause one or more processing devices of the computing devices to perform the associated set of operations. In a particular embodiment, a logic element may include one or more non-transitory computer-readable media having instructions thereon that, when executed by one or more processing devices of one or more computing devices, cause the one or more computing devices to perform the associated set of operations. As used herein, the term “module” may refer to a collection of one or more logic elements that, together, perform a function associated with the module. Different ones of the logic elements in a module may take the same form or may take different forms. For example, some logic in a module may be implemented by a programmed general-purpose processing device, while other logic in a module may be implemented by an application-specific integrated circuit (ASIC). In another example, different ones of the logic elements in a module may be associated with different sets of instructions executed by one or more processing devices.
The first logic 1002 may obtain chromatography data from chromatography system 100. This may include instructing chromatography system 100 to perform an analysis on one or more samples. Additionally, first logic 1002 can store the chromatography data provided by chromatography system 100 in a database or filesystem and retrieve the chromatography data therefrom as needed. First logic 1002 can log events of the chromatographic system 100, such as the time when a process is started, the user initiating the process, the samples processed, the instrument methods used to process the samples, status indicators from the chromatographic system 100, errors detected by the chromatographic instruments, and the like. First logic 1002 may also log maintenance events performed on the instrument and usage of consumables. Additionally, first logic 1002 can log changes to instrument methods including the time the change was made, the user that initiated the change, when a second user reviewed the change, and the like. Further, first logic 1002 may prevent using an instrument method until a second-eye review is performed to approve changes made to the method.
The second logic 1004 may analyze the chromatography data. In various embodiments, second logic 1004 can determine baselines, apply smoothing, identify peaks, integrate peak areas, perform peak matching, and the like. In various embodiments, the second logic 1004 can store the results of the analyses in a database, file system, or other storage. Second logic 1004 can also log events of the data analysis, such as time when analysis was performed, the samples analyzed, the data analysis methods used to analyze the samples, and the like. Additionally, second logic can log changes to data analysis methods including the time the change was made, the user that initiated the change, when a second user reviewed the change, and the like. Additionally, second logic 1004 may prevent using a data analysis method until a second-eye review is performed to approve changes made to the method.
The third logic 1006 may identify linked events in the audit logs. For example, events may be linked by workflow, such that events related to the instrument during data collection of a data set and instrument methods used during the data collection, and events related to the data analysis performed on the data set and the data analysis methods used can be linked even though the events may be logged in multiple different locations. Additionally, third logic 1006 may link maintenance event logs from the instrument used to collect the data with the data collected before or after the maintenance events. Further, the third logic 1006 can include providing a user interface for viewing the linked logs and may further provide alerting a user of particular linked events.
For example, it may be desirable to log batch numbers of consumables, such as buffers and columns used during the chromatographic separation.
For example, linking data collected with the batch number of a buffer used may allow for the identification of a bad batch of buffer that negatively impacts a workflow. In another example, linking a column change event with data collected before the column change may explain low quality of data collected due to degradation in column performance.
At 2002, first operations may be performed. For example, the first logic 1002 of a support module 1000 may perform the operations of 2002. The first operations may include obtaining chromatography data from chromatography system 100. This may include instructing chromatography system 100 to perform an analysis on one or more samples. Additionally, the first operations can include storing the chromatography data provided by chromatography system 100 in a database or filesystem and retrieve the chromatography data therefrom as needed. The first operations can include logging events of the chromatographic system 100, such as the time when a process is started, the user initiating the process, the samples processed, the instrument methods used to process the samples, status indicators from the chromatographic system 100, errors detected by the chromatographic instruments, and the like. The first operations may also include logging maintenance events performed on the instrument and usage of consumables. Additionally, the first operations can include logging changes to instrument methods including the time the change was made, the user that initiated the change, when a second user reviewed the change, and the like. Further, first operations may prevent using an instrument method until a second-eye review is performed to approve changes made to the method.
At 2004, second operations may be performed. For example, the second logic 1004 of a support module 1000 may perform the operations of 2004. The second operations may include analyzing the chromatography data. In various embodiments, the second operations can determine baselines, apply smoothing, identify peaks, integrate peak areas, perform peak matching, and the like. In various embodiments, the second operations can store the results of the analyses in a database, file system, or other storage. The second operations can also include logging events of the data analysis, such as time when analysis was performed, the samples analyzed, the data analysis methods used to analyze the samples, and the like. Additionally, the second operations can include logging changes to data analysis methods including the time the change was made, the user that initiated the change, when a second user reviewed the change, and the like. Further, the second operations may prevent using a data analysis method until a second-eye review is performed to approve changes made to the method.
At 2006, third operations may be performed. For example, the third logic 1006 of a support module 1000 may perform the operations of 2006. The third operations may include identifying linked events in the audit logs. For example, events may be linked by workflow, such that events related to the instrument during data collection of a data set and instrument methods used during the data collection, and events related to the data analysis performed on the data set and the data analysis methods used can be linked even though the events may be logged in multiple different locations. Additionally, third operations may link maintenance event logs from the instrument used to collect the data with the data collected before or after the maintenance events. Further, the third operations can include providing a user interface for viewing the linked logs and may further provide alerting a user of particular linked events.
The scientific instrument support methods disclosed herein may include interactions with a human user (e.g., via the user local computing device 5020 discussed herein with reference to
The GUI 3000 may include a data display region 3002, a data analysis region 3004, a scientific instrument control region 3006, and a settings region 3008. The particular number and arrangement of regions depicted in
The data display region 3002 may display data generated by a scientific instrument (e.g., the scientific instrument 5010 discussed herein with reference to
The data analysis region 3004 may display the results of data analysis (e.g., the results of analyzing the data illustrated in the data display region 3002 and/or other data). For example, data display region 3002 may display chromatograms or peak tables resulting from the analysis of data collected by the scientific instrument.
The scientific instrument control region 3006 may include options that allow the user to control a scientific instrument (e.g., the scientific instrument 5010 discussed herein with reference to
The settings region 3008 may include options that allow the user to control the features and functions of the GUI 3000 (and/or other GUIs) and/or perform common computing operations with respect to the data display region 3002 and data analysis region 3004 (e.g., saving data on a storage device, such as the storage device 4004 discussed herein with reference to
In various embodiments, GUI 3000 can include a display of linked audit events related to a workflow from various audit logs corresponding to different components of the system. In various embodiments, GUI 3000 may include a listing of the linked audit events in a single chronological list. The listing may include links to the linked audit events in individual audit logs so that a user may review the context of the linked event in the individual audit log. In other embodiments, GUI 3000 may include a list of audit events from one set of audit logs with an indication of linked audit events from other audit logs and a link to access those linked events in the other audit logs.
As noted above, the scientific instrument support module 1000 may be implemented by one or more computing devices.
The computing device 4000 of
The computing device 4000 may include a processing device 4002 (e.g., one or more processing devices). As used herein, the term “processing device” may refer to any device or portion of a device that processes electronic data from registers and/or memory to transform that electronic data into other electronic data that may be stored in registers and/or memory. The processing device 4002 may include one or more digital signal processors (DSPs), application-specific integrated circuits (ASICs), central processing units (CPUs), graphics processing units (GPUs), cryptoprocessors (specialized processors that execute cryptographic algorithms within hardware), server processors, or any other suitable processing devices.
The computing device 4000 may include a storage device 4004 (e.g., one or more storage devices). The storage device 4004 may include one or more memory devices such as random access memory (RAM) (e.g., static RAM (SRAM) devices, magnetic RAM (MRAM) devices, dynamic RAM (DRAM) devices, resistive RAM (RRAM) devices, or conductive-bridging RAM (CBRAM) devices), hard drive-based memory devices, solid-state memory devices, networked drives, cloud drives, or any combination of memory devices. In some embodiments, the storage device 4004 may include memory that shares a die with a processing device 4002. In such an embodiment, the memory may be used as cache memory and may include embedded dynamic random access memory (eDRAM) or spin transfer torque magnetic random access memory (STT-MRAM), for example. In some embodiments, the storage device 4004 may include non-transitory computer readable media having instructions thereon that, when executed by one or more processing devices (e.g., the processing device 4002), cause the computing device 4000 to perform any appropriate ones of or portions of the methods disclosed herein.
The computing device 4000 may include an interface device 4006 (e.g., one or more interface devices 4006). The interface device 4006 may include one or more communication chips, connectors, and/or other hardware and software to govern communications between the computing device 4000 and other computing devices. For example, the interface device 4006 may include circuitry for managing wireless communications for the transfer of data to and from the computing device 4000. The term “wireless” and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a nonsolid medium. The term does not imply that the associated devices do not contain any wires, although in some embodiments they might not. Circuitry included in the interface device 4006 for managing wireless communications may implement any of a number of wireless standards or protocols, including but not limited to Institute for Electrical and Electronic Engineers (IEEE) standards including Wi-Fi (IEEE 802.11 family), IEEE 802.16 standards (e.g., IEEE 802.16-2005 Amendment), Long-Term Evolution (LTE) project along with any amendments, updates, and/or revisions (e.g., advanced LTE project, ultra mobile broadband (UMB) project (also referred to as “3GPP2”), etc.). In some embodiments, circuitry included in the interface device 4006 for managing wireless communications may operate in accordance with a Global System for Mobile Communication (GSM), General Packet Radio Service (GPRS), Universal Mobile Telecommunications System (UMTS), High Speed Packet Access (HSPA), Evolved HSPA (E-HSPA), or LTE network. In some embodiments, circuitry included in the interface device 4006 for managing wireless communications may operate in accordance with Enhanced Data for GSM Evolution (EDGE), GSM EDGE Radio Access Network (GERAN), Universal Terrestrial Radio Access Network (UTRAN), or Evolved UTRAN (E-UTRAN). In some embodiments, circuitry included in the interface device 4006 for managing wireless communications may operate in accordance with Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Digital Enhanced Cordless Telecommunications (DECT), Evolution-Data Optimized (EV-DO), and derivatives thereof, as well as any other wireless protocols that are designated as 3G, 4G, 5G, and beyond. In some embodiments, the interface device 4006 may include one or more antennas (e.g., one or more antenna arrays) to receipt and/or transmission of wireless communications.
In some embodiments, the interface device 4006 may include circuitry for managing wired communications, such as electrical, optical, or any other suitable communication protocols. For example, the interface device 4006 may include circuitry to support communications in accordance with Ethernet technologies. In some embodiments, the interface device 4006 may support both wireless and wired communication, and/or may support multiple wired communication protocols and/or multiple wireless communication protocols. For example, a first set of circuitry of the interface device 4006 may be dedicated to shorter-range wireless communications such as Wi-Fi or Bluetooth, and a second set of circuitry of the interface device 4006 may be dedicated to longer-range wireless communications such as global positioning system (GPS), EDGE, GPRS, CDMA, WiMAX, LTE, EV-DO, or others. In some embodiments, a first set of circuitry of the interface device 4006 may be dedicated to wireless communications, and a second set of circuitry of the interface device 4006 may be dedicated to wired communications.
The computing device 4000 may include battery/power circuitry 4008. The battery/power circuitry 4008 may include one or more energy storage devices (e.g., batteries or capacitors) and/or circuitry for coupling components of the computing device 4000 to an energy source separate from the computing device 4000 (e.g., AC line power).
The computing device 4000 may include a display device 4010 (e.g., multiple display devices). The display device 4010 may include any visual indicators, such as a heads-up display, a computer monitor, a projector, a touchscreen display, a liquid crystal display (LCD), a light-emitting diode display, or a flat panel display.
The computing device 4000 may include other input/output (I/O) devices 4012. The other I/O devices 4012 may include one or more audio output devices (e.g., speakers, headsets, earbuds, alarms, etc.), one or more audio input devices (e.g., microphones or microphone arrays), location devices (e.g., GPS devices in communication with a satellite-based system to receive a location of the computing device 4000, as known in the art), audio codecs, video codecs, printers, sensors (e.g., thermocouples or other temperature sensors, humidity sensors, pressure sensors, vibration sensors, accelerometers, gyroscopes, etc.), image capture devices such as cameras, keyboards, cursor control devices such as a mouse, a stylus, a trackball, or a touchpad, bar code readers, Quick Response (QR) code readers, or radio frequency identification (RFID) readers, for example.
The computing device 4000 may have any suitable form factor for its application and setting, such as a handheld or mobile computing device (e.g., a cell phone, a smart phone, a mobile internet device, a tablet computer, a laptop computer, a netbook computer, an ultrabook computer, a personal digital assistant (PDA), an ultra mobile personal computer, etc.), a desktop computing device, or a server computing device or other networked computing component.
One or more computing devices implementing any of the scientific instrument support modules or methods disclosed herein may be part of a scientific instrument support system.
Any of the scientific instrument 5010, the user local computing device 5020, the service local computing device 5030, or the remote computing device 5040 may include any of the embodiments of the computing device 4000 discussed herein with reference to
The scientific instrument 5010, the user local computing device 5020, the service local computing device 5030, or the remote computing device 5040 may each include a processing device 5002, a storage device 5004, and an interface device 5006. The processing device 5002 may take any suitable form, including the form of any of the processing devices 4002 discussed herein with reference to
The scientific instrument 5010, the user local computing device 5020, the service local computing device 5030, and the remote computing device 5040 may be in communication with other elements of the scientific instrument support system 5000 via communication pathways 5008. The communication pathways 5008 may communicatively couple the interface devices 5006 of different ones of the elements of the scientific instrument support system 5000, as shown, and may be wired or wireless communication pathways (e.g., in accordance with any of the communication techniques discussed herein with reference to the interface devices 4006 of the computing device 4000 of
The scientific instrument 5010 may include any appropriate scientific instrument, such as a chromatographic system 100 in
The user local computing device 5020 may be a computing device (e.g., in accordance with any of the embodiments of the computing device 4000 discussed herein) that is local to a user of the scientific instrument 5010. In some embodiments, the user local computing device 5020 may also be local to the scientific instrument 5010, but this need not be the case; for example, a user local computing device 5020 that is in a user's home or office may be remote from, but in communication with, the scientific instrument 5010 so that the user may use the user local computing device 5020 to control and/or access data from the scientific instrument 5010. In some embodiments, the user local computing device 5020 may be a laptop, smartphone, or tablet device. In some embodiments the user local computing device 5020 may be a portable computing device.
The service local computing device 5030 may be a computing device (e.g., in accordance with any of the embodiments of the computing device 4000 discussed herein) that is local to an entity that services the scientific instrument 5010. For example, the service local computing device 5030 may be local to a manufacturer of the scientific instrument 5010 or to a third-party service company. In some embodiments, the service local computing device 5030 may communicate with the scientific instrument 5010, the user local computing device 5020, and/or the remote computing device 5040 (e.g., via a direct communication pathway 5008 or via multiple “indirect” communication pathways 5008, as discussed above) to receive data regarding the operation of the scientific instrument 5010, the user local computing device 5020, and/or the remote computing device 5040 (e.g., the results of self-tests of the scientific instrument 5010, calibration coefficients used by the scientific instrument 5010, the measurements of sensors associated with the scientific instrument 5010, etc.). In some embodiments, the service local computing device 5030 may communicate with the scientific instrument 5010, the user local computing device 5020, and/or the remote computing device 5040 (e.g., via a direct communication pathway 5008 or via multiple “indirect” communication pathways 5008, as discussed above) to transmit data to the scientific instrument 5010, the user local computing device 5020, and/or the remote computing device 5040 (e.g., to update programmed instructions, such as firmware, in the scientific instrument 5010, to initiate the performance of test or calibration sequences in the scientific instrument 5010, to update programmed instructions, such as software, in the user local computing device 5020 or the remote computing device 5040, etc.). A user of the scientific instrument 5010 may utilize the scientific instrument 5010 or the user local computing device 5020 to communicate with the service local computing device 5030 to report a problem with the scientific instrument 5010 or the user local computing device 5020, to request a visit from a technician to improve the operation of the scientific instrument 5010, to order consumables or replacement parts associated with the scientific instrument 5010, or for other purposes.
The remote computing device 5040 may be a computing device (e.g., in accordance with any of the embodiments of the computing device 4000 discussed herein) that is remote from the scientific instrument 5010 and/or from the user local computing device 5020. In some embodiments, the remote computing device 5040 may be included in a datacenter or other large-scale server environment. In some embodiments, the remote computing device 5040 may include network-attached storage (e.g., as part of the storage device 5004). The remote computing device 5040 may store data generated by the scientific instrument 5010, perform analyses of the data generated by the scientific instrument 5010 (e.g., in accordance with programmed instructions), facilitate communication between the user local computing device 5020 and the scientific instrument 5010, and/or facilitate communication between the service local computing device 5030 and the scientific instrument 5010.
In some embodiments, one or more of the elements of the scientific instrument support system 5000 illustrated in
In some embodiments, different ones of the scientific instruments 5010 included in a scientific instrument support system 5000 may be different types of scientific instruments 5010; for example, one scientific instrument 5010 may be a chromatography system, while another scientific instrument 5010 may be a chromatography-mass spectrometry system. In some such embodiments, the remote computing device 5040 and/or the user local computing device 5020 may combine data from different types of scientific instruments 5010 included in a scientific instrument support system 5000.
While the present teachings are described in conjunction with various embodiments, it is not intended that the present teachings be limited to such embodiments. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art. Further, in describing various embodiments, the specification may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the various embodiments.
The subject patent application is a U.S. National Stage filing under 35 U.S.C. § 371 of international patent cooperation treaty (PCT) application No. PCT/EP2022/068857, filed Jul. 7, 2022, and entitled “SMART AUDIT TRAIL REVIEW WORKFLOW”, which applications claim the benefit of priority from U.S. Provisional Patent Application No. 63/220,663, filed Jul. 12, 2021, and entitled “SMART AUDIT TRAIL REVIEW WORKFLOW,” the entireties of which priority applications are hereby incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2022/068857 | 7/7/2022 | WO |
Number | Date | Country | |
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63220663 | Jul 2021 | US |