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Tags: Blanking Manual revert |
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| ==7. Document management==
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''7.1''' The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.2''' The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision. <br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.7''' The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.8''' The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.9''' The system shall support the addition of accurate cross-references and page numbers to new documents.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''7.10''' The system shall be capable of uniquely identifying documents created in and added to the system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==8. Resource management==
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| {|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
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| ! colspan="1" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''8.1''' The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.3''' The system shall allow training sessions to be scheduled for personnel.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.5''' The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''8.8''' The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==9. Compliance management==
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| {|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''9.1''' The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.2''' The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.3''' The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.4''' The system's audit trail shall document the previous and current value of a modified field.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.5''' The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.6''' The system shall prevent a user from copying and pasting the electronic signature of another user.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''9.7''' The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==10. Instrument and equipment management==
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| {|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''10.1''' The system should provide a means for tracking usage of laboratory equipment and instruments.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.2''' The system shall provide a means for planning the use of and reserving equipment and instruments.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.3''' The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.4''' The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.5''' The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.6''' The system shall be able to group instruments together in specific ways, including by type and laboratory location.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.7''' The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.8''' The system shall provide clear alerts or notifications when an instrument nears its calibration due date.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.9''' The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.10''' The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.11''' The system shall be able to link a calibration activity to certified reference material or designated measurement processes. The system shall be capable of uniquely identifying documents created in and added to the system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.12''' The system shall support the use of predefined intervals when calculating Instrument event dates.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.13''' The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.14''' The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''10.15''' The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==11. Batch and lot management==
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''11.1''' The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''11.2''' The system shall maintain the links between component parts of a batch and track the batch throughout the system.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''11.3''' The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''11.4''' The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''11.5''' The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==12. Scheduled event management==
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''12.1''' The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''12.2''' The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''12.3''' The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''12.4''' The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''12.5''' The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==13. Instrument data capture and control==
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| {|
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''13.1''' The system shall be able to trigger an instrument event after a definable number of uses of that instrument.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.2''' The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.3''' The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.4''' The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.5''' The system should be able to accept the results uploaded from an interfaced instrument.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.6''' The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.7''' The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''13.8''' The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==14. Standard and reagent management==
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| {|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''14.1''' The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''14.2''' The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''14.3''' The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''14.4''' The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''14.5''' The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| ==15. Inventory management==
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| {|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
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| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| | style="padding:10px; background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
| |
| |}
| |
| |}
| |
|
| |
| ==16. Investigation management==
| |
|
| |
| {|
| |
| | STYLE="vertical-align:top;"|
| |
| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0" width=80%
| |
| |-
| |
| ! colspan="1" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
| |
| |-
| |
| ! style="color:brown; background-color:#ffffee;"|Requirement and response
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| |-
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| | style="padding:10px; background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
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| | style="padding:10px; background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
| |
| | style="padding:10px; background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| | style="padding:10px; background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
| |
| | style="padding:10px; background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
| |
| | style="padding:10px; background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
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| |-
| |
| | style="padding:10px; background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.<br /> <br /><div align="center"><hr width=60%></div><br/>'''RESPONSE''': <br /> <br />
| |
| |-
| |
| |}
| |
| |}
| |
