LIMS USER REQUIREMENTS CHECKLIST (Including Questions you must ask a LIMS Vendor)

Transcription

1 (Including Questions you must ask a LIMS Vendor) Ref. 1 General - Commercial 1.1 Where is the HQ of the vendor, who are the shareholders and where does the financing of the vendor come from? 1.2 Is LIMS the core business of the vendor i.e. the reason for the existence of the company? 1.3 If LIMS is just a part of the total business what percentage of the business is LIMS sales and support? 1.4 Provide a brief history of the vendor record in terms of the versions supplied, the upgrades provided and the current versions supported. 1.5 What quality systems are in place at the relevant vendor sites? 1.6 Does the vendor perform regular customer surveys to check on customer satisfaction? Are copies of the surveys made available to both existing and prospective users? 2 LIMS Projects 2.1 Do the vendor s own employees configure and implement your LIMS? If not, who is this work contracted out to is it companies or self-employed LIMS User Requirements Checklist (Blank) v1 Page 1 of 24

2 individuals? If non-employees are involved in configuration and implementation work what happens if the project does not meet requirements or is seriously late compared to promised delivery times? 2.2 What programming skills are necessary for the further configuration of your system? Are you prepared to allow us to use the configuration tools to design part of our own system before we commit to a purchase? 2.3 If custom coding or use of a proprietary scripting language is required to configure your system where is the coding done and under what operating procedures? Who owns that code? Is the code held in ESCROW? 2.4 Can I write the code if so how will we/you maintain it and ensure it is compatible with the next version of LIMS? LIMS User Requirements Checklist (Blank) v1 Page 2 of 24

3 Ref. 2.5 Would you be prepared to install a configured system on a Proof of Concept basis? If so what cost would be involved? 3 General - Technical 3.1 What development tools have been used in the creation of the LIMS e.g. Microsoft C#. 3.2 Is the system scalable and therefore suitable for small organisations as well as global corporations? 3.3 Is the system capable of operating via a Windows desktop as well as via a browser? 3.4 If a dual Windows/Web operation is possible please explain how the various screens are made available in both modes. Are the screens designed and implemented once or twice? 3.5 Does the system allow concurrent operation of three or more database groups in the standard system e.g. for active, archive and training databases LIMS User Requirements Checklist (Blank) v1 Page 3 of 24

4 etc? 3.6 Can the database groups have different configurations with different user authorities for each? This is particularly useful for training new members of staff without any risk to the active system. It also allows different sites or departments to have their own database if needed. 3.7 Does the system allow selective archiving and re-activation? 4 System Configuration/Customisation 4.1 Is your system configurable so that it can exactly meet our requirements? If yes, is system configuration achieved without the use of coding? If code is written does this mean that each implementation has different coding? What impacts does this have on support and upgrading of the system? Can we be trained to use your configuration tools? LIMS User Requirements Checklist (Blank) v1 Page 4 of 24

5 If yes, what background and qualifications are needed for the people attending the training course? How long is the training course? 4.2 Are the configuration tools supplied with the delivered system and are they genuinely point-and-click tools requiring no programming skills? 4.3 Is the system configurable by the nonprogrammer and without use of special languages? Does this mean that an authorised trained user can make changes to the system as business needs change? Or do we have to involve you, the vendor? This is important because if a trained user as opposed to a programmer can keep the system at the optimum level consistent with changing and/or expanding user requirements there is the dual benefit of lower cost of ownership plus future proofing. 4.4 Once a screen is designed is it usable via desktop and/or web without any changes i.e. one design suits all operational environments? 4.5 Are user configuration changes supported by the vendor at no extra cost on the annual support agreement? LIMS User Requirements Checklist (Blank) v1 Page 5 of 24

6 Ref. 4.6 What restrictions are there when defining different work flows? 4.7 What can be changed when designing screens? 4.8 Can the system provide screen configuration features such as:- a) ability to define an unlimited number of screens including multiple screens per function? How do they fit into configurable work flows? b) drag and drop techniques for field/ button positioning? c) use of a variety of different Windows controls including, but not limited to, bit map images, check boxes, combo boxes, edit boxes etc? d) dynamic sizing of fields and buttons? e) specification of tabbing order? f ) definition of jumps (tabbing order)? g) simple method of specifying control identity? h) simple method of specifying function of a button? i) choice of font/size for screen or individual control text? 4.9 Can the system provide menu configuration features such as:- a) ability to define multi-level menus? b) ability to define different menus for LIMS User Requirements Checklist (Blank) v1 Page 6 of 24

7 different users? c) ability to use terminology suitable for the application? 4.10 Can the system provide terminology configuration for the following:- a) menu items? b) static text on screens? c) text on buttons? d) error messages? e) help files? 4.11 Can I start part of the workflow on the web (e.g. remote sample registration) and continue the workflow on a desktop/lan PC e.g. sample receipt, preparation, results entry, validation and approval? 4.12 Can I see identical reports via the desktop and web clients? 5 User Access/Security 5.1 Describe the security access system in detail. 5.2 Can specific screens and/or menus be defined for each individual user and/or class of user? This impacts on user-friendliness as all screens will be relevant to the responsibilities of each user e.g. no superfluous buttons and fields. 5.3 Can user access be restricted in the LIMS User Requirements Checklist (Blank) v1 Page 7 of 24

8 following ways:- a) by location e.g. access to own data only? b) by function? c) by type of authority e.g. read/write/ delete? d) by screen? e) by field/button on each accessible screen? f) by menu design? 5.4 In a multiple database system, can user authority be separately set for each database? In an archive database, for example, the user access levels are normally restricted to view only. 5.5 Does the system include a time-out function that enables times to be set individually for each user and/or class of user? This optimises the use of system licenses as well as preventing unauthorised access to abandoned screens. 5.6 Does your system include enforced password changes on a regular basis, minimum password length, control and reporting of failed log-ins etc. to comply with 21CFR Part 11? 5.7 Can an authentication function be configured particularly for highresponsibility functions i.e. extra level of security? LIMS User Requirements Checklist (Blank) v1 Page 8 of 24

9 For example, the use of the Approve button for sample results could be set up such that confirmation of the user i.d. and password is requested on screen. 6 Functionality - Sample/work Registration Note this is an extensive section that reflects the importance of getting the sample registration process correct. 6.1 Does your system support the following types of registration:- a) single sample? b) single sample with copy feature? c) batch registration with/without copy feature? d) registration templates? e) registration from external system and/or scheduler? f) spreadsheet style registration including data capture from Excel? 6.2 Does your system allow sequential and automatic allocation of sample/work numbers? 6.3 Does the system allow a separate automatic and sequential batch number for situations when batches of samples are submitted? 6.4 When work is divided into different categories (e.g. different sample types) does the system allow an unlimited number of parallel automatic sample/work numbering systems without the use of multiple databases? LIMS User Requirements Checklist (Blank) v1 Page 9 of 24

10 Ref. 6.5 Can data relating to sample/work submitters and sample types be picked from pre-defined lists? 6.6 Can details of submitters and sample types be viewed from the registration screen? 6.7 Can pre-defined lists be edited from the registration screen i.e. without exiting registration, for users with an appropriate user authority? Is this action audit trailed? 6.8 Can data for other fields on the registration screen be picked from pre-defined lists as required? 6.9 Can fields have masking to ensure that correct format of data is entered? 6.10 Does system support date fields which also allow date calculations? For example, it may be useful to have the system automatically calculate a completion date for the sample testing Does system support short form date calculations e.g. CD + 5d to represent current date plus 5 days? If yes does this also apply to weeks, months and years? 6.12 Does system allow fields to be populated automatically by defining a default value within the system which can be overtyped by a user with suitable authority Is bar-code support provided LIMS User Requirements Checklist (Blank) v1 Page 10 of 24

11 e.g. sample i.d, sample location i.d. etc? 6.14 Can reports e.g. worksheets and labels be automatically generated from the registration screen? For example, when the register button is pressed can labels and worksheets be printed at a defined printer? 6.15 Does easy on-screen configuration exist on the system to get the best fit for a particular user or work type? 6.16 Can each user, or group of users, have the option of their own design of registration screen suitable for their purpose? 6.17 For user or work specific screens, will the displayed lists be filtered automatically to fit the relevant user/work requirements? 6.18 When a sample type is selected from a pre-defined list at registration will a default test list, appropriate to the given sample type be automatically assigned? 6.19 If a product is an unknown can a default test list be assigned by selecting, e.g. Unknown Liquid, Unknown Solid etc? 6.20 Can users with appropriate authority have the ability to modify the assigned test list including the addition and deletion of tests with full audit trailing? 6.21 Can certain tests be made LIMS User Requirements Checklist (Blank) v1 Page 11 of 24

12 compulsory with no allowance for editing? 6.22 Can the system allow the allocation of additional limits for each individual sample as it is registered? These limits would be in addition to any test related limits e.g. detection ranges, ph 0 to 14 etc, and product related limits e.g product specification Can multiple windows of test limits be assigned with different responses such as reject, fail, warning etc? 6.24 Are rule based limits supported in the system e.g. if sample is from a male use limits X, if from a female use limits Y? Or if the product is for customer X use limits X but for customer Y use limits Y Are all details of a test available for viewing from the registration screen? Does this include historical versions of the test and the appropriate audit trail? 6.26 Are test methods available for viewing from any screen? How is this achieved? 6.27 Are multiple notepad facilities available at sample registration (useful for non-structured data)? Will all notes be stamped with date, time and user i.d? 6.28 Can standard text or templates stored in external files be easily transferred LIMS User Requirements Checklist (Blank) v1 Page 12 of 24

13 into the notepad? 6.29 Does the system allow the allocation of standard phrases to buttons e.g. in the notepads, in order to minimise repeated typing of frequently used text? 6.30 Is there is a means of locking access to previously entered notes? 6.31 Can voice recognition software such as Dragon be used with the system? This is useful when the user is viewing a specimen through a microscope and wants to simply describe the details without leaving the microscope Does the system come with screen configuration tools that allow the number, position and type of fields to be specified for the registration screens? 6.33 Can buttons on the registration screen be configured e.g. definition of the function the button activates? 6.34 Can labels on buttons be made to be dynamic such that, for example, entry of blood as a sample type changes button labels or even fields and field names compared to an entry of urine as the sample type? This would mean that one registration screen could be used for multiple types of samples without the user seeing any optional fields. LIMS User Requirements Checklist (Blank) v1 Page 13 of 24

14 Ref Is a parent-child sample relationship supported within the system with an unlimited number of levels? This is useful for tracking aliquots and partial samples as used in biobanks, for example. 7 Functionality - Sample Receipt 7.1 Is a sample receipt function provided with the system? Useful when some work is preregistered prior to the availability of the samples. The receipt function is needed to track the arrival of the samples. Useful in checking whether all expected samples arrive in the laboratory and also the time interval between registration and receipt for each sample can be measured. The sample turnaround time in the laboratory should be measured from the receipt date and time. 7.2 Does sample receipt allow for single sample, multiple sample, batch sample and global sample receipt utilising bar-codes where needed? 7.3 Is sample receipt an automatic status level in the system? 8 Functionality - Sample Preparation 8.1 Is a sample preparation function LIMS User Requirements Checklist (Blank) v1 Page 14 of 24

15 provided with the system? This would be used to indicate that samples must complete the preparation stage before they are ready for testing. 8.2 Does sample preparation allow for single sample, multiple sample, batch sample and global sample preparation? 8.3 Is sample preparation an automatic status level in the system? 8.4 Can sample preparation functionality allow different preparation stages to be specified and tracked as completed, for example? Can the stage order also be specified such that jumped steps are prevented? This can be used to track the correct use of a method in the laboratory. 9 Functionality - Work Scheduling 9.1 Does system allow the creation of worklists and worksheets? 9.2 Are worklists/worksheets available by test, instrument, resource and laboratory as a minimum? 9.3 Can worklists be made available for downloading to an instrument system? 10 Functionality - Result Entry Does system include:- LIMS User Requirements Checklist (Blank) v1 Page 15 of 24

16 Ref Result entry by sample - entry of any/all test results for a single sample? 10.2 Result entry by test - entry of one test result for multiple samples? 10.3 Result entry for multiple samples and multiple tests in spreadsheet style? 10.4 Result import from a variety of sources including files and instruments? 10.5 Viewing of results previously entered using same selection criteria as for selection of samples for result entry? 10.6 Viewing of test status? 10.7 Scheduling of re-test from result entry screen? 10.8 Option of forcing entry of reason for a re-test? 10.9 Highlighting of out of limits results whether the limits are associated with a sample, test or product type? Capability of allocating unlimited number of limits that can be associated with the product, test and/or sample? The use of a wide range of calculations - similar to those available in Microsoft Excel, for example? Cross-test and cross-sample calculations? The following result types within a LIMS User Requirements Checklist (Blank) v1 Page 16 of 24

17 test:- a) static text? b) numeric? c) calculated numeric? d) short text? e) long text? f) menu selection with limits? g) date/time? h) sample field (any field/s populated in the registration screen)? i) linked (allows viewing of information from a third party package e.g. chromatogram)? Result validation? Sample approval/completion? Audit trailing of results at the component level i.e. time/date/operator i.d? This is important where one test may consist of many components, the results for each component being entered by different users at different times Tests that can consist of any combination of result types as listed in 10.13? 11 Static Data Tables 11.1 Does the system include data tables for:- a) security definitions? LIMS User Requirements Checklist (Blank) v1 Page 17 of 24

18 b) user information? c) sample submitters and/or customers? d) products/sample types/unknowns? e) test definitions? f ) laboratory resources? g) instruments? h) workstations? Can users define additional tables? 11.2 Is full version control provided for all specified tables? For example, if a test is modified by changing a limit is a new version of the test created that has to be approved by an authorised user before it can be used in a live situation? Is the replaced version maintained complete with all historic links to samples? 11.3 Is full auditing provided for all specified tables? 11.4 Does system allow user definable screens for all static tables? 11.5 Does system allow multiple views of any static table with views listed separately on the appropriate menu or workflow screen? This will be needed to split, for example, chemistry tests and microbiology tests. LIMS User Requirements Checklist (Blank) v1 Page 18 of 24

19 Ref. 12 Reporting 12.1 What reporting tools does the system support? 12.2 Is automatic report numbering provided? 12.3 Is event triggered reporting - reports generated by sample status change, for example included? 13 Miscellaneous 13.1 Does system allow storage of BLOB files e.g. pictures, documents associated with a sample or a test? 13.2 Can a document management capability be fully integrated within the system? 13.3 Are in-screen calculations supported by the system? Can the system be configured to automatically take values from one or more specified screen fields and use built-in operators to calculate results which are then written to one or more different screen fields? Note this should be in addition to any calculations associated with test results Are project/batch, sample and test status levels automatically updated as work progresses? Completion of the entry of results for a test changes the test status to Tested automatically, for example. LIMS User Requirements Checklist (Blank) v1 Page 19 of 24

20 Ref Can I start with a sample tracking system and then upgrade to LIMS later on? If yes, what extra software will be delivered? 13.6 Describe the sample tracking features of your LIMS. How is this used to monitor inventory for example? 13.7 Can I start with a standalone Stability Study Management system and then upgrade to LIMS later on? If yes, what extra software will be delivered? 13.8 Can I use Oracle or SQL Server databases or both? 13.9 Can I have separate databases for different departments within my organisation (they may be in different locations)? Can these databases be configured differently? Can I configure screens to connect seamlessly to external databases and data sources such as my previous LIMS for historic data, SAP and Excel? 14 Options LIMS User Requirements Checklist (Blank) v1 Page 20 of 24

21 Ref Is there an Instrument Calibration and Maintenance module that includes: a) instrument inventory management? b) scheduling of instrument calibration intervals? c) checking of calibration results against pre-set limits? d) scheduling of maintenance/ inspection intervals? e) recording of non-routine occurrences? f) monitoring of instrument status? g) handling instruments consisting of several components e.g modular HPLC? 14.2 Is there a Training Records. Management module that includes: a) record of details of training courses? b) assignment of users to courses? c) attendance records? d) facility for tracking changes in course details? e) automatic scheduling of refresher courses? f) course evaluation? g) full screen configurability? 14.3 Is there a Frequency Testing module that includes: a) ability to specify testing frequency for each test on a substance/product? b) ability to force tests for the first 'n' samples of a new substance/product? c) facility for full testing automatically LIMS User Requirements Checklist (Blank) v1 Page 21 of 24

22 if a specified time period has elapsed since the last sample of a particular substance/ product? 14.4 Is there a Shelf-life Study Management module that includes: a) highly configurable screens and menus? b) full protocol design? c) storage inventory calculation prediction and monitoring? d) sample location management? e) flexible study and batch interrelationships? f) configurable review and approval systems? g) use of study templates? h) condition cycling? i) storage operation management including auditing of container placement, moves, relocation, staging, pulls and scrapping? j) automated or manual registration of samples into LIMS? 14.5 Is there a Business Management module for organisations such as contract laboratories that will include: a) Flexible test pricing with discounts, fast turnaround surcharges etc? b) Support of multiple currencies? c) Support of the addition of VAT or similar? d) Creation of quotations with. LIMS User Requirements Checklist (Blank) v1 Page 22 of 24

23 unique numbering? e) Conversion of quotations to jobs? f) Creation of pro-forma invoices, final invoices or transfer of data to an accounts package of your choice? g) Creation of management reports indicating, for example, number of jobs, samples, tests, income, costs etc. for designated time period? h) Much more to meet individual customer requirements via built-in configuration tools? 15 System Support 15.1 If I have a support question can I telephone a help-desk and immediately talk to a technical person familiar with my system? If yes, where would this person be located and what time can I call them? If no, what support scheme is in place? 15.2 Does the vendor have global coverage if relevant? If so what are the support centre locations? 15.3 What is the vendor track record with respect to upgrade paths e.g. number of years/versions? LIMS User Requirements Checklist (Blank) v1 Page 23 of 24

24 Ref Are new version upgrades supplied to customers at no cost? Is this true if the new version is a complete re-write of the previous version? 15.5 How much effort is typically needed for the implementation of an upgrade and what do I have to pay? 15.6 Will an upgrade preserve my configuration or custom code as well as my data? 15.7 Provide an example of at least one customer who has followed an upgrade pathway since the first version of the system If I have a need to modify a screen, a workflow or a menu on my system is there any way of ing it to you so that you can modify/correct it and e- mail it back? 15.9 Do you guarantee that we will always be able to upgrade to the next version? LIMS User Requirements Checklist (Blank) v1 Page 24 of 24