Loss The Documents and Spreadsheets (White Paper)

Manage all ALM requirements types efficiently and more accurately with Orcanos QPack Requirements Next Generation tools. By Rami Azulay VP Marketing and Sales at Orcanos.


It is well known by now that poor requirements management is among the most affecting contributing factors in the failure of a project. Misleading requirements management can put your organizational compas on the wrong direction and lead to unfocused teams, rework time, regulation violations, out-of-control costs and unhappy customers. If you use documents, spreadsheets, emails, homegrown tools and other tools to keep track of your business, customer or product requirements, you could be starting on the wrong foot and put your project at risk. Have you ever forgotten to notify all the people that needed to know about an update? And if you did notify, how sure your are that it was well understood? Have you ever been seeking for the correct version of a document before going into Design Review (DR) meeting? How much time are you spending on getting everyone comments into single document or had to take time to listen to people who were giving the same feedback?

This is a fact, Managing requirements is difficult with conventional office and productivity tools because they lack some key capabilities. It is not enough that we have a way to describe the requirement over and text editor a successful requirements management should also includes the ability to capture relationships between requirements that are part of the traceability requirements by any quality standard such as ISO 9001 or IEC 62304 or ISO 13485 and manage dependencies. For example, based on the level of concern related to your product there are level of depth required by the traceability used in your documents, you should be able to show how features that are being built relate to capabilities that customers have requested.

When different time zones are involved in your project that may bring another level of complexity to the communication on requirements. Each change requires a full audit trace according to the CFR 21 Part 11 if you are under such regulation restriction so that by itself will force you to maintain an history audit change on every change made to the document, never ending work and in some cases the that part of the document could be as big as the spec itself, so handling versioning and change management is crucial. When you try to manage requirements without these capabilities, the results can be low productivity, latency at project timeline and increase in costs. Using typical productivity tools, to manage requirements is like using a hammer to open a bottle. It gets the job done, but at what cost?

On the other hand, Orcanos© QPack Requirements™ Next Generation offers effective requirements management capabilities.

After 10 years in the market we can tell that these capabilities have helped Orcanos clients:

  • Reduce development costs by 52 percent.

  • Accelerate the time to market by 25 percent.

  • Reduce cost of quality by 62 percent.

This paper identifies five key benefits of the requirements management capabilities provided by  QPack Requirements™ NG that address what cannot be done with documents, emails and spreadsheets. These capabilities include requirements capture, online chat discussions, sharing, elaboration and management. Another key capability is collaboration between teams, whether they are local or globally distributed.

The benefits are:

  • Clear Understanding of a change

  • Consistency in development

  • Full V&V Traceability

  • Online – Real Time collaboration

  • Pro Active Alerts making your data work for you

Orcanos Software

With QPack Requirements™ NG your teams can collaborate more easily. After a document is ready for interested parties to review, stakeholders can use QPack Requirements™ NG to discuss and collaborate by commenting directly in the preview mode document. Important decisions can be finalized using the work item workflow and discussions are being logged by the chat feature available to the team. Now you can stop chasing down emails or making, consolidating and responding to similar comments, saving all that common wasted time. With  QPack Requirements™ NG, chat comments can be directed to team members and classified as private or public to avoid unnecessary noise between stakeholders, so the important things can be handled directly by the right person. As people make comments, QPack Requirements™ NG can send SMART email notifications, including a recent history change log as well hyperlink that enables users access to just the information they need. Review cycles are shortened and collaboration is improved even when different time zones are involved. Keeping stakeholders informed and engaged is critical. With QPack Requirements™ NG, the flexible notification mechanism can identify the team automatically and keep them in the loop of changes. Along with email notifications, QPack Requirements™ NG has improved dashboards so users exposed to  the most important information as soon as they log in to this pure HTML5 web-based application. Dashboards can have presentation of endless data dimensions, project timelines, changes that have been made in the scope of the change itself of the document that the change was discovered in along with any ongoing reviews and comments.  QPack Requirements™ NG acts as an “Absolute source of facts” and enables interested parties to access the latest information automatically. Customers don’t lie Orcanos clients have used  QPack Requirements™ NG software to reduce development costs by 52 percent and costs of quality by 62 percent, while accelerating the time to market by 25 percent.

Benefit 1: Live collaboration over documents, spreadsheets or email can cause never ending  headaches when you work with others, distance can be as short as working on the same building, and especially if you are part of a globally distributed team. Most vendors of requirement management tools will create what we call “information islands” that make it difficult to find, relate and use this information. Colleges spend too much time searching for the latest information, reviewing documents and consolidating changes. In many cases you might think you have the most up-to-date information data, unmeasured lost of time gathering everyone inputs, reviewing and combining it. As a result, requirements might be weeks out of date from the point where it started as business idea to the finish line when it is delivered. With productivity tools such as office and excel, multi-user editing is difficult and almost impossible to manage. Consequently, several versions of the document might circulate throughout the team. For that Orcanos not just giving you Next Generation tools but also accommodate them with complementary tools that will allow you to make the working habits much easier, that comes with QPack DMS™. The owners of these documents must consolidate changes, maintain an updated copy and inform teams about the changes using QPack DMS as centralized tool that both meet the regulation standard ISO 13485 sec. 4.2 as well give simple easy to adopt tool, can do all that work for you.  QPack Requirements™ NG, by contrast, offers automated requirements freezing mechanism. By that more than one person can work at the same time on the same information and collaborate wherever they are located. The latest information is available for the team to access via the web or mobile application coming all from the same house of vendor Orcanos.

Since you never rest assure that you are all in sync, team members undertake heroic measures to consolidate, understand and monitor status of their requirement. Then, decision is taken based on this information. Unfortunately, if the data is error prone, it cannot be trusted and the project is put at risk. With QPack Requirements™ NG, each member of the team can access the latest information when he needs it. The template format of the original document is preserved. If required, for each traceable requirement working item annotations, such as priority, risk, status and category, can be displayed in grid report. The contents and chant annotations can be searched, sorted and filtered. You can also save views, which enables you to do MASS change on the perspective of your data quickly and display just the  information you need. Drill down analysis is quicker and the presented data used by you is more consistent and accurate.

Benefit 2: Getting Project data in consistency can be very complex. Teams members have a need for filtering relevant information and to organize it in logical manner. With  QPack Requirements™ NG, a project admin can set up different templates for each unique type of document such as MRD, PRD, SysRS, SRS, SDD, STP, STD, STR, Risk etc. That outline templated can be the basic structure of the information to be placed into the documents using traceable items. For example, a system requirements template can include boilerplate text for the introduction and areas for functional and nonfunctional requirements. In addition, each

work item type of can be “templated” with the appropriate annotations that must be collected by the author of that particular work item. For example, system requirements are kept in a product requirements specification that includes all related product components annotations, such as cost, risk or priority, along with any additional information they might need. On the other hand looking back on traditional document tools, it is not possible annotate requirements specifications without adversely affecting the original structure and context. In addition sorting or filtering documents based on any type of information and determining which requirements are missing is not possible. At the end of the day, someone must clean up the documents and remove the annotations in a very precautions way. Then once you got the document finalize the common practice of word processing users is often to copy the requirements from their documents into spreadsheets (keeping some level of traceability) and then adding separate columns to filter by them. When the documents are updated, the users must manually synchronize the changes for all documents and spreadsheets. These manual processes are often time consuming, they don’t scale and they can introduce errors into the process.

Relationships between artifacts can be displayed in columns, along with the requirements and annotations, which increases the visibility on the project status. As an outcome you improved quality and better project management. Filters can be saved and broadcast via proactive alerts, which enables the team or single member which is assigned to a task to once again quickly change the perspective of the data to fit the needs of the stakeholder.

The real value of traceability provided by QPack Requirements™ NG is evident when a project team must respond to an audit request by any notify body or must understand the impact of a change on existing features. If you use spreadsheet you may struggle to maintain the traceability and later interpret the connections between different levels of requirements that are found in multiple documents and are related by yet another document in the form of a spreadsheet, and that can go on and on. The guidance regarding the compliance of the project activities to user requirements or assessing the impact of change becomes challenging and uncomfort. With QPack Requirements™ NG, these challenges are avoided and almost does not exist. You can record multiple relationships with many to many ratio as you see them and use rich analysis tool to view details about the related work item from your actual current preview document without having the need to navigate away. When necessary, the relationships are traversable, which enables teams to quickly navigate from one document tree to the other. You can split your screen to create the traceability between 2 documents and use the multi selection tree view mode to perform faster. The way QPack Requirements™ NG display related information in columns can highlight the gaps and find inconsistency in the document whereby user requirements were left orphaned or are missing downstream interpretation to lower level requirements or upstream to final product. Such Pre-Audit alerts which can be built into your organization process, does not leave the worst for last and just let you handle it when something needs your attention. They can help identify scope creep, whereby functionality missing project goals or business needs as described by the marketing people, which uses up valuable time. Because you can see the requirements and multiple levels of relationships graphically, you can more easily and quickly assess the impact of change. And, during design reviews (DR) when required, you can demonstrate what is needed also during an audit without having to search for multiple documents and team members. Knowledge is being preserved throughout the years and not dependency exist over people who left you company. Traceability in QPack Requirements™ NG is dynamic. As soon as someone else makes changes in the tool, an update is immediately created. If a downstream requirement changes, it automatically shows up in traceability columns for the upstream requirements. Users have access to an up-to-date traceability matrix whenever it is needed and can also see what impact the change has.

Benefit 3: The use of spreadsheets for traceability are often used to add an additional dimension to requirements documents by storing needed annotations. Additional spreadsheets are used to capture relationships for the V&V, between requirements and tests. Verification matrixes,

compliance matrixes and traceability matrixes then must be maintained separately. These manual processes do not scale and are prone to user errors. In  QPack Requirements™ NG, users can “trace as they think.” Even they can start the relations from the QPack Service Center™ They can create relationships between new Service Call to the asset RISK which is required by the IEC 60601 requirements and respond to that RISK by mitigation proofed with traceability to the mitigation method.

QPack Requirements™ NG supports automation of the creation and maintenance of the relationships throughout the application lifecycle development. This includes relationships between requirements, work items, architecture, design and test plans. It removes the “air gaps” between “information islands” that are the result of using different tools. Removing these possible gaps reduces user errors.

Benefit 4: One of the unavoidable events in a normal project lifecycle will be the introduction of a change after project kick started, the effort understanding A change create turbulent period in a project once it comes after the initial requirements have been written and agreed on. At the PDR and CDR (Critical Design Review) All parties are happy and go on their merry way to work on the initial set of requirements. Than changes occur. Customers change needs to change their business strategy or replace low priority requirement with high priority requirement. A supplier is unable to meet an original target for cost or performance. An engineer or test reveals that what was planned is not possible. Or, more simply, a requirement already acted on developed and even test, is corrected. Managing changes as effectively as possible is imperative.

Before making a change it is recommended to follow those two main steps:

  • One, analyze the impact of the change before it is made

  • Second ensuring that all impacted areas have been revised as necessary

If you are using documents and spreadsheets above guidance can not easily achieved when spread over pieces of information. It become even worse If that information had to come from a failed test or reported a defect that was raised or if a client issues an updated specification, a document or spreadsheet cannot analyze the impact. That leaves the individual responsible personnel usually to spend weeks trying to understand the impact of change. With QPack Requirements™ NG, a user can create a perspective or view of their data. That view shows allows them to do drill down quickly to any direction they wish to follow. The user of V-Module when implemented makes that work even easier. In accordance to the V&V module each requirement should be trace down to the lowest implementation details design and even to the code if software was involved or engineering drawings and then from there to other steps of the development process, such as test. Users can also explore graphically the complex map of information that can be used to understand the impact of change that spans multiple levels and even components. This information is not static, using QPack Requirements™ NG you build your solution in a way that you can share features between several products so one change can affect more than one product. It can be updated as soon as someone else makes changes in the tool. If a downstream requirement changes, it automatically shows up so users can see what impact the change might have. Doing that with traditional tools huge effort will be placed to communicate these changes among everyone that is concerned and ensuring that all

impacted areas are addressed. From upper management to production floor all stakeholders and others want and can know what changed, how it changed and if they must act on the change. With QPack Requirements™ NG, a full history is maintained every time a requirement changes and that is also according to the CFR 21 Part 11 requirement for electronic records management. The team member can refer to the history and determine what changed, who changed it and when it changed and most important on what release it was changed. Change that was introduced into older release now needs to be observed twice: once into the older release and second to the new one. QPack Requirements™ NG also takes advantage of the relationships between information. Suspicion profiles alert users of a change with additional information regarding the actual document affected by the change. Users can review and act accordingly. This event will occur on every other change, a new suspicion is raised. With a minimum of effort, changes propagate down the levels of linked information in the project.

QPack Requirements™ NG helps your whole team assess the impact of change before it happen, using existing relationships and other meta data.

Benefit 5: In order to improve the ways your can look at your data you can limited doing that if you are using documents and spreadsheet. For example, you will need to present the data in different structure based on the audience intending to review it. Your customer might want their requirements structured as a document to simplify the review process. On the other hand, the looking at the same requirements from a finance perspective may required a table layout so they can estimate how much each requirement might cost. Using spreadsheets, these alternative perspectives on the same data require creating separate versions of documents. You must then maintain them or extract and consolidate them from a variety of sources every time reports are needed. QPack Requirements™ NG stores information in a central location and presents it in the format of a document. Users can add attributes to individual statements without changing the original structure, and they can filter and sort information based on the supporting characteristics. QPack Requirements™ NG automatically maintains cross references and relationships between information so you don’t have to. It also tracks change and alerts people of change that they might need to act on.

Best practices for writing clear, unambiguous requirements that can be tested can help reduce project complexity. To align all participants on the same terms used it is recommended  to include glossaries. With QPack Requirements™ NG, the glossary is accessed from a document. You can search or update terms and even update the glossary from the

document when they are introduced.


One of the most difficult decision about tool selection is to select the right tool for the job. It is organizational decision and not individual so you need the maturity to start going in that path. With QPack Requirements™ NG you can work smarter rather than harder. Putting the right people to view the right perspectives of the data for their roles at the right time. Avoid spending weeks to manipulate many documents and spreadsheets to see clear things in a way you want can be a practice of the past. Now you can spend time working on the more important details of your project, and let the tool relief from you time-consuming and repetitive tasks. QPack Requirements™ NG enables you to control your project. You can focus on important tasks, such as building and testing, without having to manually recording every change in multiple documents and spreadsheets. You can respond quickly and work faster with while increasing  traceability for better impact analysis. Notifications are automatic and immediate so your can respond with near real time to the point of the event. Now collaboration across locations can be assess before the change happens, to create a strategy for change and to act on a required change. Open the door to success. Orcanos QPack Requirements™ NG is your solution to a smarter project. Orcanos clients have used  QPack Requirements™ NG to enable effective requirements management that helped them reduce development costs and cost of quality, while accelerating the time to market. You could be next.

For more information

To learn more about Orcanos  QPack Requirements™ NG , contact your Orcanos representative or Orcanos Business Partner, or visit the following website: www.orcanos.com

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