Pay Now or Later: Creating Solid System Application User Requirements
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This presentation will take a look at proven, thorough, yet sensible approaches to ensuring that your business is in the best position to create solid user requirements for your informatics system (e.g. LIMS, ELN, LES, CDS). Overcoming different obstacles such as lack of resources, inconsistent work processes, lack of informatics “experts”, and lack of business motivation within the company will also be addressed. In addition to generating a solid, well thought out user requirements document, the presentation will provide ways to also leverage the requirements generation exercise to improve communication, morale, and work processes, all while having a little bit of fun. For more information regarding all your Laboratory Informatics needs, visit www.csolsinc.com
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Pay Now or Later: Creating Solid System Application User Requirements
- 1. Premier Laboratory Informatics Experts Strategic Planning Implementation Validation Pay Now or Later: Creating Solid System Application User Requirements Katherine H. Temple Laboratory Informatics Consultant
- 2. © 2017 CSols, Inc. What is a URS? 2 User Requirement Specification: Just another boring IT document?
- 3. © 2017 CSols, Inc. What is a URS? 3 User Requirement Specification: Just another boring IT document?
- 4. © 2017 CSols, Inc. What is a URS? 4 A vital piece of the informatics solution puzzle
- 5. © 2017 CSols, Inc. User Requirements Specification Protects the investment in the system Keeps focus on functionality that is valuable to the business Keeps vendor focused Proves agreement on expectations between customer and vendor 5
- 6. © 2017 CSols, Inc. User Requirements Specification 6 Shows “fit for purpose” Must first define intention before proving system fulfills intended use Will be vital during validation Defines intended purpose for regulatory requirements:
- 7. © 2017 CSols, Inc. Set Yourself Up for Success Clarify the purpose and scope of the document with team members Specifies what the user expects the software to be able to do Does not define how the software will execute the functionality Keep explanations simple Always keep the floor open for questions Remind everyone there are no stupid questions 7 ?
- 8. © 2017 CSols, Inc. Overcoming Challenges: Resources 8
- 9. © 2017 CSols, Inc. Overcoming Challenges: Resources 9 Select the appropriate SMEs Just like you wouldn’t play a football game with 11 quarter backs, you don’t want only managers and team leads writing the URS
- 10. © 2017 CSols, Inc. Overcoming Challenges: Resources 10 LIMS impacts many areas, make sure all areas are represented A LIMS is like intertwining roots of a forest in how it touches all parts of the business
- 11. © 2017 CSols, Inc. Overcoming Challenges: Resources 11 Get ‘em while they’re hot! Take advantage of any momentum from project kickoff and any excitement about upcoming changes Engage resources who are excited about the project right away and take advantage of their willingness to contribute
- 12. © 2017 CSols, Inc. Overcoming Challenges: Buy-in Management support Make the project a priority 12
- 13. © 2017 CSols, Inc. Overcoming Challenges: Buy-in Management support Make the project a priority 13 Generate excitement and buzz Why will a solid URS make the project great? What’s in it for me? Recruit champions Management Non-management influencers
- 14. © 2017 CSols, Inc. Focus on the Business Needs 14
- 15. © 2017 CSols, Inc. Focus on the Business Needs 15
- 16. © 2017 CSols, Inc. Focus on the Business Needs 16 Clinic al Manufac turing Clinic al Study Management GLP LabDisc overyCommerc ial Manufac turing Development SDMS Enterprise Resource Planning (several years down the road) MES Clinical Trial Management System Clinical Single Source of Truth (SSOT) LIMS Asset Management System (Blue Mountain already in place in some areas) QC LIMS(one system preferred for GLP and QC (MG has limited ITresources for maintaining and administering multiple systems) but it is more important that the systems are fit for purpose Accounting System (most likely Deltek, might later be incorporated into ERP) MES ELN Enterprise/ electronic Content Management System (likely coming in 2016 at the same time as LMS) Learning Management System (likely coming in 2016 at the same time as EDCSor ECMS) Other clinical automation Quality/ Regulatory Management System Commercial production in ~2019
- 17. © 2017 CSols, Inc. Reviewing the URS Document Much easier to correct requirements at this stage Reviewers should be a different group of individuals, but with similar expertise to the URS authors Each requirement should be testable and specific Include quantities Avoid generalizations like “fast” or “simple” Avoid jargon, acronyms, and ambiguous terms Prioritize requirements17
- 18. © 2017 CSols, Inc. More than just a document A solid process leads to a well-written URS Improves communication Establishes a foundation of teamwork Improves understanding of the overall process Empowers SMEs Builds support for the project Provides groundwork for future improvements 18
- 19. © 2017 CSols, Inc. 19 Katherine Temple Informatics Consultant www.csolsinc.com
Editor's Notes
- Good morning and welcome to Pay Now or Later, Creating Solid System Application User Requirements My name is Katherine and my background is in both science and process improvement. Writing requirements specifications is a major part of my role as a laboratory informatics consultant at CSols. Today we’re going to focus on laboratory systems, but the information I will share could be applied to any system or type of URS. CLICK
- First, let’s talk about what a user requirements specification or URS does. A URS defines what a system needs to do to meet the needs of its users. This sound totally boring and something we should just let IT deal with, right? CLICK Absolutely not. CLICK The URS is a hugely important part of any system implementation because it impacts every subsequent implementation step and can even be part of the vendor contract If such an important document isn’t solidly created from the start, a lot of risk will be introduced to your project Today I’m going to talk about how to create a solid document and mitigate that risk early on CLICK
- First, let’s talk about what a user requirements specification or URS does. A URS defines what a system needs to do to meet the needs of its users. This sound totally boring and something we should just let IT deal with, right? CLICK Absolutely not. CLICK The URS is a hugely important part of any system implementation because it impacts every subsequent implementation step and can even be part of the vendor contract If such an important document isn’t solidly created from the start, a lot of risk will be introduced to your project Today I’m going to talk about how to create a solid document and mitigate that risk early on CLICK
- First, let’s talk about what a user requirements specification or URS does. A URS defines what a system needs to do to meet the needs of its users. This sound totally boring and something we should just let IT deal with, right? CLICK Absolutely not. CLICK The URS is a hugely important part of any system implementation because it impacts every subsequent implementation step and can even be part of the vendor contract If such an important document isn’t solidly created from the start, a lot of risk will be introduced to your project Today I’m going to talk about how to create a solid document and mitigate that risk early on CLICK
- A clearly defined URS protects your investment in the new software system CLICK A well defined document can keep the team focused on the business value and prevent vendors from seducing them with snazzy—but less valuable—upgrades CLICK The vendor then will stay focused as they know there is no room for an up-sale CLICK And finally, the URS serves as an agreement that the system will function as expected when implementation is complete CLICK
- If the system will be used in a regulated environment CLICK The system must be fit for purpose CLICK A URS is a way to define the purpose of the system in order to prove its proper fit during validation CLICK The FDA does not consider commercial software to be sufficiently proven as delivered out of the box to be suitable to perform in a regulated setting; the URS is what the system should be validated against to prove suitability CLICK
- In order to succeed with such an important document, there are a few things to do at the very beginning of the URS creation process to set yourself up for success CLICK First, you’ll want to make sure the team members understand both the purpose and the scope of the URS document CLICK They should understand that the URS defines what the system should do so they don’t get into the weeds trying to define how the system will do it CLICK Make it a rule to keep explanations simple and clear Don’t get to computer-y for the science folks and don’t let conversations get to science-y for the IT or business team members CLICK Another rule of thumb is to make sure the floor is always open for questions CLICK No one should be afraid to ask about something that might affect their ability to positively contribute to the URS CLICK
- During the URS creation process, organizational weaknesses like personality conflicts that cause roadblocks and communication problems often arise Proactively planning for these resource challenges can make them easier to overcome, but what, pray tell, do the football team of my beloved Alma Mater, a forest, and hot Krispy Kreme donuts have to do with anything? They all illustrate important points to remember when resourcing your URS creation: CLICK You must select the appropriate subject matter experts to create and review the URS; just like you wouldn’t play a football game with 11 quarter backs, you don’t want only managers and team leads writing the URS You also need to balance IT staff who understand the backend of the system with lab and business experts who understand the hands-on processes CLICK LIMS impacts many areas of an enterprise and it often reaches into departments and groups that you wouldn’t expect. I often say that LIMS has tentacles that touch all parts of the business, but I think the roots of a forest is actually a better analogy One example of these intertwining roots is a client with an accounting group who needed pricing information from the lab Unfortunately, accounting was not included during the requirements gathering stage for LIMS and their needs were not captured in the URS A clunky workaround had to be applied post-implementation to meet their need—at no small impact to the timeline and budget CLICK And just like a hot Krispy Kreme donut, you want to grab ‘em while their hot! Take advantage of any momentum from project kickoff and any excitement about upcoming changes Engage resources who are excited about the project right away and take advantage of their willingness to contribute CLICK
- During the URS creation process, organizational weaknesses like personality conflicts that cause roadblocks and communication problems often arise Proactively planning for these resource challenges can make them easier to overcome, but what, pray tell, do the football team of my beloved Alma Mater, a forest, and hot Krispy Kreme donuts have to do with anything? They all illustrate important points to remember when resourcing your URS creation: CLICK You must select the appropriate subject matter experts to create and review the URS; just like you wouldn’t play a football game with 11 quarter backs, you don’t want only managers and team leads writing the URS You also need to balance IT staff who understand the backend of the system with lab and business experts who understand the hands-on processes CLICK LIMS impacts many areas of an enterprise and it often reaches into departments and groups that you wouldn’t expect. I often say that LIMS has tentacles that touch all parts of the business, but I think the roots of a forest is actually a better analogy One example of these intertwining roots is a client with an accounting group who needed pricing information from the lab Unfortunately, accounting was not included during the requirements gathering stage for LIMS and their needs were not captured in the URS A clunky workaround had to be applied post-implementation to meet their need—at no small impact to the timeline and budget CLICK And just like a hot Krispy Kreme donut, you want to grab ‘em while their hot! Take advantage of any momentum from project kickoff and any excitement about upcoming changes Engage resources who are excited about the project right away and take advantage of their willingness to contribute CLICK
- During the URS creation process, organizational weaknesses like personality conflicts that cause roadblocks and communication problems often arise Proactively planning for these resource challenges can make them easier to overcome, but what, pray tell, do the football team of my beloved Alma Mater, a forest, and hot Krispy Kreme donuts have to do with anything? They all illustrate important points to remember when resourcing your URS creation: CLICK You must select the appropriate subject matter experts to create and review the URS; just like you wouldn’t play a football game with 11 quarter backs, you don’t want only managers and team leads writing the URS You also need to balance IT staff who understand the backend of the system with lab and business experts who understand the hands-on processes CLICK LIMS impacts many areas of an enterprise and it often reaches into departments and groups that you wouldn’t expect. I often say that LIMS has tentacles that touch all parts of the business, but I think the roots of a forest is actually a better analogy One example of these intertwining roots is a client with an accounting group who needed pricing information from the lab Unfortunately, accounting was not included during the requirements gathering stage for LIMS and their needs were not captured in the URS A clunky workaround had to be applied post-implementation to meet their need—at no small impact to the timeline and budget CLICK And just like a hot Krispy Kreme donut, you want to grab ‘em while their hot! Take advantage of any momentum from project kickoff and any excitement about upcoming changes Engage resources who are excited about the project right away and take advantage of their willingness to contribute CLICK
- During the URS creation process, organizational weaknesses like personality conflicts that cause roadblocks and communication problems often arise Proactively planning for these resource challenges can make them easier to overcome, but what, pray tell, do the football team of my beloved Alma Mater, a forest, and hot Krispy Kreme donuts have to do with anything? They all illustrate important points to remember when resourcing your URS creation: CLICK You must select the appropriate subject matter experts to create and review the URS; just like you wouldn’t play a football game with 11 quarter backs, you don’t want only managers and team leads writing the URS You also need to balance IT staff who understand the backend of the system with lab and business experts who understand the hands-on processes CLICK LIMS impacts many areas of an enterprise and it often reaches into departments and groups that you wouldn’t expect. I often say that LIMS has tentacles that touch all parts of the business, but I think the roots of a forest is actually a better analogy One example of these intertwining roots is a client with an accounting group who needed pricing information from the lab Unfortunately, accounting was not included during the requirements gathering stage for LIMS and their needs were not captured in the URS A clunky workaround had to be applied post-implementation to meet their need—at no small impact to the timeline and budget CLICK And just like a hot Krispy Kreme donut, you want to grab ‘em while their hot! Take advantage of any momentum from project kickoff and any excitement about upcoming changes Engage resources who are excited about the project right away and take advantage of their willingness to contribute CLICK
- Another challenge you might face is getting organizational buy-in CLICK Of course, you should already have management support for any project CLICK And management will need to make it clear that the project is a priority for the business Management support will definitely move the project forward, CLICK but sometimes it can seem a bit forced CLICK To get more organic buy-in from your organization, generate buzz and excitement about your project and the benefits of getting in at the ground level during the URS phase CLICK Explain why the new system will be great but also how the URS will make it great CLICK Explain to groups or departments what’s in it for them Why will they benefit from contributing to the URS effort? There are several ways to do this: informally by talking to subject matter experts while you’re in the lab, with scheduled meetings, or email newsletters But never underestimate the power of a free lunch. Even if attendees bring their own lunch, a Lunch and Learn can be a great casual environment to disseminate information and build excitement about the project CLICK Another way to get buy-in is to have a champion for the project who is really excited about and likely to share that excitement around the office or lab CLICK Sometimes this is a manager but more often CLICK There are influencers outside of management that people respect and listen to; ask these influencers to join your project or spread the news about the project where it will be most effective CLICK
- Another challenge you might face is getting organizational buy-in CLICK Of course, you should already have management support for any project CLICK And management will need to make it clear that the project is a priority for the business Management support will definitely move the project forward, CLICK but sometimes it can seem a bit forced CLICK To get more organic buy-in from your organization, generate buzz and excitement about your project and the benefits of getting in at the ground level during the URS phase CLICK Explain why the new system will be great but also how the URS will make it great CLICK Explain to groups or departments what’s in it for them Why will they benefit from contributing to the URS effort? There are several ways to do this: informally by talking to subject matter experts while you’re in the lab, with scheduled meetings, or email newsletters But never underestimate the power of a free lunch. Even if attendees bring their own lunch, a Lunch and Learn can be a great casual environment to disseminate information and build excitement about the project CLICK Another way to get buy-in is to have a champion for the project who is really excited about and likely to share that excitement around the office or lab CLICK Sometimes this is a manager but more often CLICK There are influencers outside of management that people respect and listen to; ask these influencers to join your project or spread the news about the project where it will be most effective CLICK
- Now that we know some challenges to expect, how can we begin building a great URS? CLICK I recommend starting by mapping current processes to define the business needs CLICK This can be a painful process and coming to agreement can be difficult. The process of building consensus will directly benefit the quality of the URS, but will help build relationships as well Many issues with the process will be uncovered and the ways to fix those need to be captured in the URS CLICK For example, in this scenario, we’d like to get rid of the process of printing out chromatograms, typing in data, signing each page, printing an Excel file with calculations, and then taping all the pages in a paper notebook There are many ways to fix these issues, but the URS doesn’t need to capture how—and your team needn’t waste time speculating about how—the URS only needs to capture what the system needs to do In this example, the requirements should cover a bidirectional interface between the LC and LIMS to pass sample information and results back and forth, electronic signatures, calculations on raw data, rounding and significant figure rules, and archiving and search capability for the raw data This LIMS functionality eliminates the clunky paper-based process, but in order to do that well, the LIMS requirements must be identified and well-defined in the URS CLICK Each area should capture current and future states for their processes to make sure all requirements are documented, but to the point I made earlier about intertwined roots, it can be helpful to diagram the future state of the overall IT outlook This makes sure all stakeholders have been included in the process and also includes IT to make sure all the systems fit together and will work together CLICK
- Now that we know some challenges to expect, how can we begin building a great URS? CLICK I recommend starting by mapping current processes to define the business needs CLICK This can be a painful process and coming to agreement can be difficult. The process of building consensus will directly benefit the quality of the URS, but will help build relationships as well Many issues with the process will be uncovered and the ways to fix those need to be captured in the URS CLICK For example, in this scenario, we’d like to get rid of the process of printing out chromatograms, typing in data, signing each page, printing an Excel file with calculations, and then taping all the pages in a paper notebook There are many ways to fix these issues, but the URS doesn’t need to capture how—and your team needn’t waste time speculating about how—the URS only needs to capture what the system needs to do In this example, the requirements should cover a bidirectional interface between the LC and LIMS to pass sample information and results back and forth, electronic signatures, calculations on raw data, rounding and significant figure rules, and archiving and search capability for the raw data This LIMS functionality eliminates the clunky paper-based process, but in order to do that well, the LIMS requirements must be identified and well-defined in the URS CLICK Each area should capture current and future states for their processes to make sure all requirements are documented, but to the point I made earlier about intertwined roots, it can be helpful to diagram the future state of the overall IT outlook This makes sure all stakeholders have been included in the process and also includes IT to make sure all the systems fit together and will work together CLICK
- Now that we know some challenges to expect, how can we begin building a great URS? CLICK I recommend starting by mapping current processes to define the business needs CLICK This can be a painful process and coming to agreement can be difficult. The process of building consensus will directly benefit the quality of the URS, but will help build relationships as well Many issues with the process will be uncovered and the ways to fix those need to be captured in the URS CLICK For example, in this scenario, we’d like to get rid of the process of printing out chromatograms, typing in data, signing each page, printing an Excel file with calculations, and then taping all the pages in a paper notebook There are many ways to fix these issues, but the URS doesn’t need to capture how—and your team needn’t waste time speculating about how—the URS only needs to capture what the system needs to do In this example, the requirements should cover a bidirectional interface between the LC and LIMS to pass sample information and results back and forth, electronic signatures, calculations on raw data, rounding and significant figure rules, and archiving and search capability for the raw data This LIMS functionality eliminates the clunky paper-based process, but in order to do that well, the LIMS requirements must be identified and well-defined in the URS CLICK Each area should capture current and future states for their processes to make sure all requirements are documented, but to the point I made earlier about intertwined roots, it can be helpful to diagram the future state of the overall IT outlook This makes sure all stakeholders have been included in the process and also includes IT to make sure all the systems fit together and will work together CLICK
- MORE than just the URS document (checkbox) Improves communication: SME group participation have opened channels across the organization Contacts have been established, relationships developed “I’ll call Bruce in Production and talk to him…………” Understanding of overall process illuminates potential impact of a groups changes across the organization Will facilitate discussions outside of a group when changes are being assessed, looking for input. Improves morale across the organization SME’s who are passionate love working with others of the same passion. The excitement becomes contagious and is also felt by others that work with the SME’s. Empowerment shown in the project increases the feeling that everyone matters and is important. Relationships develop for future initiatives as people who have had a positive experience on one project are eager to repeat and also work with the other SME’s again. People that are making progress and feel they are empowered are happy and inevitably will have some fun along the way. Some of the SME’s will develop friendships they wouldn’t have had if not for the opportunity to work with others. These friendships strengthen the organization tremendously for future growth. Provides groundwork for future improvements Proven avenue for improvements is set Communication channels available Empowerment will prompt SME’s to identify efficiencies when they see them Communication improves Success breeds success Summary: Development of User Requirements is the most important task in determining the success of a project. In addition to the solid requirements, there are so many intangibles that can be obtained through the process of generating these requirements. Make sure that as an organization, you provide the proper resource, time, excitement and priorty to generating these requirements so they are solid. The payoff is well worth it and the alternative could be devastating!
- “The URS is usually the first document to be written in the life cycle validation of a CDS. The rationale for this approach is that some of the requirements specified might impact the validation strategy for the system such as a phased roll-out and this will need to be written into the validation plan.” Comment: The majority of organizations do not address the above issues until they HAVE to which is when a system is actually being developed (or worse…implemented). This is too late as timelines are not sacrificed to sufficiently address and therefore the systems developed are not optimal and efficient. Thus, PAY NOW OR PAY LATER Part of the reason this happens is all the things listed here are HARD for humans and involve a lot of things (like direct confrontation, making big decisions and people are afraid to screw up if they committed to something—CYA concept—examining faults in the current system: taking and accepting blame)
- Ensures that adequate details are covered in the URS If it’s important to a group or SME, it needs to be in the requirements Give the group the proper time to adequately discuss issues/suggestions Break into subgroups if necessary (divide and conquer) Scope will be determined through these discussions Empower SME groups to make some decisions The future process details are the REQUIREMENTS!! SCOPE is also determined in this part of the process as if it’s in the requirements it is in scope. Avoid scope creep later if the URS is well thought out and complete. URS contents identify the business needs. The only way to identify these appropriately is to put in the work! Make sure the SME’s identify the current processes first Many times groups really don’t understand outside of their immediate area, so the organizational understanding is inaccurate Develop process flows Bonus: These can also be used for reference to educate others as well (training, management meetings, etc) GREAT opportunity for cross-functional communication and education Will often lead to easily identify real needs and improvements in the current process Will expose current weaknesses A great opportunity to fix things that aren’t any good, but that you don’t necessarily need new software to fix like keeping KPIs or a clunky process or a wasteful process People are change-resistant and making small adjustments at this stage can get further buy-in for the project and smooth the path for future change Identify pain points Identify areas where improvements can be made Give SMEs the opportunity to voice their opinions COME TO A CONSENSUS! Involve management and decision makers before finalizing the future state Make sure that SME’s identify the desired future process Use current process flows to identify where changes/improvements can be made This will force INVALUABLE discussion across the different groups and areas Will also identify current issues that need to be addressed These were always there, but just never had the correct light to expose. Often forces management to make decisions due to differences in philosophy and opinion Again, these issues were always there, just never addressed. Give every SME the opportunity to voice opinions Builds confidence Empowers Shows teamwork