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CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution
or use without the express permission of EtQ is prohibited. Copyright 2012 EtQ, Inc. All rights reserved.
www.versesolutions.com
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www.versesolutions.com
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Applications, Databases, servers,
software, etc.
Security Protocols – Firewall,
data recovery, backups, etc.
Presentation Layer: Web page,
“apps”
Access points: Computers,
Tablets, Smartphone, etc.
www.versesolutions.com
LevelofITFlexibility
Time
Terminals – Each
client had it’s own
solution – “Fat
Client”
Pre-90’s
Web Based Solutions
– “thin client” – Still
within Internal IT
90’s -- 2000
Externally Housed Cloud
Applications, accessed
on virtual environments in
a managed hosted
environment
2000 and beyond
www.versesolutions.com
Cloud Applications
www.versesolutions.com
Cost
• Pay as you go
• Save $$$ on hardware
Focus on Business
Process
• Less IT overhead
• Usage versus Admin
Security and Recovery
• Top level security
• Backup and Up Time
Scalable for Growth
• Ability to expand use
• Grows with your business
World Wide Access
• Leverage the Web
• Accessible anywhere
• SOC 1 Type II
• US/EU Safeharbor
• TrustE
• ISO 27001
www.versesolutions.com Courtesy of Awesome Cloud Services
www.versesolutions.com
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Dedicated SaaS EnvironmentMulti-Tenant SaaS Environment
www.versesolutions.com
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www.versesolutions.com
Audits
Document
Control
Corrective
Action
Training
Reporting /
Reviews
•Variable Locations
•Connection Points
•Multiple departments
•External auditing
•Centralized Location
•Multi-Dept. Access
•Variable Access
methods
•Central location
•Affects multiple
departments
•Visibility in the process
•Potential for Secure,
external touches (SCAR)
•Potential for company-
wide access
•Links to Document
Control
•Integration with other
systems
•No limitation on
accessing data
•Immediate alerts on
Quality events
•Company-wide
reporting and mgmt
review
www.versesolutions.com
Do Your
Research
Don’t Over
think the RFP
Keep the Short
list, “Short”
Control the
Evaluation
Avoid Politics
www.versesolutions.com
•
•
•
•
–
–
–
–
•
www.versesolutions.com
CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution
or use without the express permission of EtQ is prohibited. Copyright 2012 EtQ, Inc. All rights reserved.
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• Adaptability to your existing business processes
• Do not settle for “cookie-cutter” forms,
workflows
• Configuration versus Customization
• Configuration – allows you to administer and
adapt the solution
• Customization – requires a development
effort = more $$$
• More Cost-Effective to self-configure,
especially if configuration is simple and well-
defined
• Cost-Savings in putting the flexibility in your
hands over a development team
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• Three common models of deployment:
• On-Premises: You purchase the solution,
install it locally on your hardware $$$
• Hosted or Co-Located: You purchase the
solution, but the vendor hosts it for you $$
• Software as a Service (SaaS): You subscribe
to use the software, but do not own anything
(only your data) $
• Multi-Tenant or Dedicated Environment?
•Multi-tenant = less flexibility, security issues
•Dedicated = more flexibility, secure database
•Dedicated is usually the same cost as multi-
tenant from architecture standpoint – push for
a dedicated environment!
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• Look and Feel are important to End user
adoption!
• Users are more likely to adopt a solution that mimics
their way of doing things
• Usually an afterthought, it is important to consider the
appearance of the system to the company
• Mimicking your processes, forms, layouts
• Critical to success of the implementation
• Needs to be easily adapted and changed
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• A QMS Generates a lot of Data!
• If you cannot organize and analyze, you’re missing a lot
• Need a good Reporting tool to help make decisions
• Reporting can be expensive – especially if it’s an
add-on
• Look for built-in reporting tools
• Look for strong searching/charting capabilities
• Quickly create reports for management
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• Scalability matters, even for a small operation!
• Scalability is the flexibility to grow the solution –
sites, suppliers, etc.
• System needs to be built to scale!
• What type of scalability?
• Administration – site-specific processes
• Corporate rollup – one corporate standard, with
variable site-level processes
• Look for a scalability solution that allows you to
be common, but unique at the same time!
www.versesolutions.com
Flexibility
Deployment
Look and
Feel
Reporting
Scalability
End Users
• End Users are the most important!
• System hinges on their acceptance
• If it doesn’t feel right – rejection may occur
• Users hate change – transition the change
easier with a familiar solution
• Process matching, look and feel, colors, etc
• All will help ease the transition
• Look for a solution that has flexibility in the
look and feel, and takes end user adoption into
account
www.versesolutions.com
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•
•
•
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Customer
(End User)
Hosting
(Cloud, etc)
IT Admin
(Vendor)

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Using the Cloud to Deploy Quality Management Software

Editor's Notes

  1. My name is Tim Lozier, and I am the Product Strategy Manager for Verse Solutions. Today I would like to talk a little bit about this thing we call the Cloud, what it is, what the benefits are, and how Quality and QMS systems fit into this way of deploying technology.
  2. So,I want to talk about is some of the background on Cloud Computing, and a few types of deployment options when we look at Enterprise Software. Next I want to talk a little about what exactly are the benefits of the cloud and some things to look for, and how an automated QMS system can potentially fit into the whole cloud computing scheme. We’ll also touch on some of the considerations on the process of selecting a QMS, with the cloud in mind.
  3. So, what exactly is the cloud, and cloud computing? I’m sure in the past few years, you’ve all heard of the term “cloud” and there is a lot of chatter in the industry that surrounds the concept. So much so, that we often get a mixed bag of information surrounding who offers cloud, and what that exactly means. I’ve heard the term “Cloudwash” thrown around, and it is true – there is a gray area on what is really being offered in the cloud, versus some hybrid or mixed version of the concept. Cloud computing by definition is an emerging deployment method that fosters the delivery of applications in real-time over the Internet. It’s a massive grouping of computing power – large warehouses and data centers that are coupled together to create one gigantic computing system, and all the memory, storage and bandwidth is partitioned into virtual environments – little pieces – that applications are able to draw from. Large web services firms are creating this environments and enabling businesses to run applications, infrastructures, and platforms on this “stack” of environments, and vendors and customers are able to draw as much from it as they need to make their products work for the client. There is no one single hardware point – computers access the cloud, and the applications serve up the solution – apps, if you will – for use, and there is no other IT footprint other than that in the customer’s eyes. It’s also backed up with an infrastructure that manages security, data recovery, monitoring, administration, backups and others. The cloud is having unlimited computing power to enable a solution to meet whatever needs the customer has, with no limitations on hardware or computing power.
  4. The cloud represents an evolution in how we view IT systems. If you look at this over time, computing technology was very point-based – terminals and desktop clients were the beginnings, and the software that resided on these computers were installed in singular fashion – also known as fat clients. Some systems evolved into terminals that had direct access to a mainframe computer and were the old “green screen” technology. At the time it was effective and served the purpose, but it didn’t have much flexibility – you were limited to only those clients that had the software installed. With the advent of the Web, we saw a shift into more technology that was web based, networked with a server, and the actual clients didn’t have software necessarily installed. Through a web browser, you could access the server that stored the solution from any client and be productive. This was the thin client evolution. However, this too has limitations, especially on the server-side. You had to make sure the server could handle the load of the people accessing it, the storage for records and documents, and the speed to handle multiple tasks. Once that server hit a threshold, you would need to add more servers, invest in a larger server or scale down your activity. With the cloud, the limitations are reduced significantly. Most cloud environments are real-time scalable; they are able to add memory, storage, bandwidth in real-time to match the loads that are being put on the solution, and adjust accordingly. Furthermore, you don’t own any hardware, so the server maintenance is potentially reduced. More and more, we see solutions illustrating cloud concepts into their solutions, mainly because businesses are trying to consolidate their IT footprint, save overhead and streamline their operations. The cloud helps to accomplish this.
  5. Before we get into it any further, let’s just examine the overall picture of what Cloud actually means. This diagram represents the types of deployments that exist in many systems today. You have what’s called the On-Premises model. This is what we know as the internal server model, and essentially is where you are purchasing a software solution, and installing it on your own gear, or hardware, in your own server room. You as a company are responsible for managing all the IT-related tasks – backups, patches, maintenance, etc. – as well as using, configuring and administering the product itself. For cloud computing, there are different types of solutions that exist. You have what’s called an infrastructure as a service, whereby you are not managing the hardware itself, but everything else – the server software, the security, the databases, as well as the application. All you are leaving out is the physical hardware itself. Then you have a Platform as a Service. This is where not only the hardware, but the sever-software elements are also managed by the vendor. The vendors is taking care of everything but the application itself, which you are responsible for administering, configuring and for some life science or regulated business, validating. Most enterprise solutions have some sort of platform as a service approach, with additional services to help configure and run the application and complete any necessary validation. Finally, you have the Software as a Service model. In this model, you do not need to do anything significant, but log on and start using the solution. You may do some limited configurations, you may even do a basic validation on pieces of the solution, but in the end, your goal is to get in and use the solution, and let the vendor manage the rest for you. In the Quality Management space, most cloud applications fall somewhere between PaaS and SaaS, with the rest still doing On Premises deployment.
  6. So that is cloud computing in a nutshell and where we are today with business technology. What are the key benefits of moving to a cloud-based system. This is just a quick overview on the different reasons why people are so interested in this type of deployment. The first is Cost: Cloud is a subscription-based service, which means you don’t actually own the infrastructure. You’re not buying a piece of the cloud; you are subscribing to use the cloud. This is beneficial in the long term for growing businesses, mainly because you are not incurring upfront hardware costs. For a growing business, purchasing a server and hosting internally may prove challenging because you have Server administration costs, you have server costs, you have replacement costs – if a server becomes maxed out or outdated, then you have to invest in more servers, or new servers. Cloud gives you the flexibility and scalability you need, without extensive overhead, administration, and server maintenance. All this leads to the next benefit, which is your focus area. As a business, you want to be able to focus on your business processes and business operations, and not the administration of a solution. I’ve seen many companies spend as much time ensuring the server is up and running and fixing operating systems and application servers as they do actually using solutions. For some organizations, it may be ok to have this administration element, but for others, the key thing is the “set and forget it” approach. You want to set up your solution, have the system maintenance and administration managed for you as part of the service, and just focus on using the solutions to run your business. The next thing is a an area that many may share concerns and mixed opinions on, and this is security. When the cloud first came onto the scene several years back, the biggest concern was security and data protection. After all, for many the processes and records within a system like a QMS are sensitive and represent information that is critical to a company’s success and competitive advantage. So there is a hesitancy to look at a cloud model and have security concerns. Over the past 5 years or so, this concept has waned a bit and more cloud providers have sought to demonstrate their security features. Some of the key things you want to look for in this area are: What is in place: Look for firewalls, backups, Encryption, recovery methods, and availability zones within the provider. These are methods that ensure that the connection is secure, limits access to another other than you company, and allows you to retrieve the data at any point in time. A lot of providers not only have backups, but they have multi-zone backups, which hold a back up in one region, and one in another region. So that if the entire region goes down, your data is still secure and retrievable. Certifications – you also want to ensure that not only the cloud provider but also a solution has gone through certification to attest to their key privacy and security standards. SOC 1Type II certification (formerly SAS 70) is a audited certification on your operating standards with respect to security and privacy. This ensures that you are following the proper procedures when conducting security operations. Other ones, like the ISO 27001 standard, manage Information Security Management and are designed to operate with security in mind. Privacy certifications, such as SafeHarbor and TrustE ensure that your data and information is kept private and secure. There are plenty of considerations to look for in data security and privacy; the key is to do your homework and ask questions about what is the security, and it is backed up by audited certifications. Moving on, another key benefit is the ability to scale. I touched on this before, but one of the key benefits is the scalable nature of the cloud – there is no limitation to what you are able to do in terms of growing the system. In some cases, cloud computing systems can monitor the level of activity and make adjustments in real-time to accommodate your load on the system. For a company that is looking to scale their business and not invest in more IT resources, the cloud is great for scalability. One last point is the concept of World-wide access. Since the cloud is available from anywhere, you can access it anywhere with an Internet connection. Sometimes you have internal systems that can only be accessed from within the company’s four walls. In other cases, you need to use a pass-thru to get into a the internal server to gain access. With the cloud, all the infrastructure is in a fixed point, and the company user are not limited by where they are in the world to be productive.
  7. I grabbed this info graphic from a cloud service group because I think it’s a good way to see what the growth of this deployment represents. You see that the cloud computing industry has grown from $46B to $150B in just 6 years, more than tripling. This year they are also predicting that 30% of IT groups within major corporations will have two or more cloud service applications, and by 2014 (this year) 60% of the server workload will be virtualized. Now, this is aggregated data, but it certainly shows that this is no longer an emerging trend – it is becoming a core part of the dynamic of technology today.
  8. The next consideration to think about is how you want to exist in the cloud. There are typically two types solutions that providers will offer. The first is known as multi-tenant, and this is a model where the software application is a universal platform, and all customers will share the platform itself, but will have their settings and data partitioned and kept separate. So you have multiple companies on a shared platform, and it serves up their data, based on their login. Some of the pros of this model is that it provides a common, consistent platform that is universal to all customers, and there is a perceived cost advantage – in some cases it can be seemingly more cost-effective to keep a common platform. However, some things to consider with multi-tenancy is the flexibility of the system; since you are on a shared solution, you may be limited in the amount of configuration or modification you can do to the solution. This is because they need to keep a common platform, so any modification beyond individual settings may not be allowed. Some companies don’t like this model because of perceived security concerns. A single environment with multiple companies on the same instance draws more questions on how secure is the data. Many data models are robust and can maintain this security, but the perception is still there. Lastly, you have questions on upgrades and patches. Software will always get upgrades, but in a multi-tenant model, you as a customer cannot control when this happens. So, while you may be notified of the upgrade and it’s usually at an odd-hour, you still have to plan for training and adapting to an upgrade, even if it’s not convenient for you or your company. On the other side of the cloud so to speak is the dedicated environment, or private cloud. This is where you essentially get your own piece of the cloud and an environment that is dedicated solely to your company. What this provides is more flexibility in how much you can adapt the solution and configure, control over upgrades and scheduling of tasks, and a data model that only includes your information, accessing your private application. In many cases, this model is sometimes perceived as less-cost effective in terms of monthly or annual costs, but, depending on the nature of the setup, it is typically just as cost-effective – most cloud environments, whether dedicated or not, are pretty cost effective. So, when you are looking at cloud, consider the multi-tenant and dedicated environment and determine what will work best for you.
  9. So, we’ve spent time talking about the cloud as a technology and as a deployment method. Let’s talk a bit about what makes cloud a viable option for a QMS deployment. When you really boil it down, most QMS solutions are going to be similar in terms of the technology deployment, whether it’s in the cloud or not. The real choices you make depend on your company operations, IT footprint and how you want to deploy a solution. However, you look at the concept of QMS as a flexible, process-based workflow automation tool, you want to have flexibility to match these processes. Having a cloud solution that matches the flexibility can be a benefit – you make changes and configure the solution, or you add or remove processes, you want a system that is going to have the infrastructure stability to support whatever changes you make. Moreover than that, you also want to have that scalability. We all know that Quality is not siloed in one department – it is pervasive across departments, operational areas, suppliers, customers and beyond. Having a system that can scale beyond the departmental level, expand to more operational areas, and even extend to suppliers and others will fall in line with the overall goals of the QMS. You want a QMS that can do this; your technology should be able to adapt as well. Cloud is inherently scalable in this sense. Another consideration is cost and consolidation. IT is always looking to integrate and consolidate systems, and having a QMS that can reduce the IT footprint can help along these lines. Moving a QMS to the cloud can represent a piece of this strategy, and can help to reduce or event eliminate any overhead associated with the deployment and maintenance of the system.
  10. Hopefully we all know what processes are critical to a QMS, so I didn’t want to go through a copious list of processes and areas. What I want to do is highlight some key processes that would potential work in a cloud environment, for all the reasons I listed before. Let’s look at Audits and Audit Management. Most of the time Audits are not done in a single place – you have variable locations, different types of audits that cover different departments, regions, areas and beyond. Having a cloud-based solution gives you the flexibility to conduct your audits from multiple locations, record the data from anywhere, and have a centralized location where this is all stored. If you are using external sources for auditing, or doing external audits, having the cloud to store your findings is also a benefit. Similarly, having a cloud-based Document Control system gives you the ability to have a central location for storing and controlling records. You can foster the flexibility to have access across multiple sites, departments, operational areas, and you can also set variable access and security on those documents. Some external records can be created, and the internal records can be kept internal, based on access levels within the QMS. Cloud can help to have a centralized and secure location that is not limited by your four walls. This can also apply to Corrective Action. Many times, CARs are multi-departmental, or even involve a supplier component. With the right level of access and a secure cloud connection, you can determine what access levels are needed and provide this access to the appropriate parties at the appropriate step in the process, and ensure that you are involving the right people at the right time. Employee Training is another area that a centralized and universal cloud deployment can work. With company-wide access, you can ensure training is available across departments, you can link to Document Control or even tie into other systems. Cloud-based solutions have the ability to help foster this wide-range of access and maintain the compliance and security you need. Another one is reporting and reviews. With a centralized and cloud-based location, you can gain company-wide access to the data and reports on quality, you can look at all areas that are generating this data, and see a corporate view on the QMS, from a central location, from anywhere in the world. Again, there is nothing to say that these are not processes you cannot do with a traditional, OnPremises model, but the cloud is equally as proficient in handling these types of processes, and provides the level of flexibility to extend Quality even easier.
  11. So we’ve gone through a bit about cloud, and touched on some of the elements that QMS can benefit from a cloud deployment. One thing I would like to cover is some of the common methods for going about the process of selecting a QMS solution, and some of the considerations, both from a technology perspective and a business perspective Most often, people are unfamiliar or have limited experiencewith the process of selecting software solutions. This is primarily because people really don’t do it that often – software is usually a once-in-a-while purchase, so many will approach it from different methods. Here are just a few pointers on the best way to approach a QMS software project. Remember, like anything, software selection is a process, and the more controlled your process is, the better you will be able to make more informed decisions.We start with research: When you begin the selection process, you should do your homework. Identify the which vendors are in the market, identify the different technologies such as cloud or On Premises, within the different vendors and understand the typical components/applications. By identifying and understanding the market, you can better communicate with the vendors on your needs and their capabilities. Sometimes the vendors may use varying terminology (Corrective Action, CAR, CAPA…all the same thing, for example, or again the cloudwash on their hosting or cloud options), and once you crack that code, you’ll be able to see a more level view on what’s being offered. From a cloud technology perspective, if you are looking to explore cloud as an option, make sure you track down all the security certifications, the cloud providers, and also understand what cloud options they offer.The next happens to a lot of businesses, and this is to Not “Over think” the RFP: The key to a successful Request for Proposal (RFP) is not in creating a copious feature list; it is focusing on solving a business need. The goal of an RFP is differentiating one vendor from the next. Overly generic features that focus on functions often provide detail on products or technology deployments, but little visibility into how the product solves a business need and how the type of deployment can benefit them. Center your RFPs around the key business needs, the technology needs (like the deployment needs and security needs) and let the vendor explain how they can solve this need through their solution. Striking this balance of simple, yet focused is an important distinction in selection…too much and you’re lost in the details – too little and you’ll not get a good understanding of the software’s capabilities.Another point is to Keep your “shortlist” Short: Often, many companies will move forward in the selection process with more than three orfour vendors, which can push the selection timeline out too far. Limit your shortlist to three or four, and have a selection team evaluate and conduct research. There are plenty of outside forces and networking with peers that will also provide valuable information in this selection. Also, consider the vendor’s corporate fit to your business—a good relationship with a vendor can go a long way. When you look at the cloud as an option, you want to be comfortable with their experience in this type of deployment – if they have a good track record and been deploying cloud solutions for a long time, that will help to determine your comfortability with them.Another thing you want to do is Control the Evaluation process: As the vendor selection process continues, make sure that your company is driving the evaluation. Vendors tend to show features and tools that may not be related to your business, simply because they are “flashy” and “sizzle.” They may show you all the details of their cloud structure and dive deep into protocols that you may or may not need to know. Keep the process focused on your specific needs, and deployment goals. By keeping the focus on you and your goals, you are not getting sidetracked on anything else.Finally, and this is always a challenge especially when considering the emerging cloud deployments, you want to avoid letting politics get in the way: There is a great deal of subjectivity that can arise when reviewing applicable vendors. This especially tends to come up with cloud and the opinions that revolve around it. IT may want to weigh in here, and it’s important to have all opinions and concerns addressed, but in a productive format. It’s always hard to do, but subjective measures such as personality conflicts, a prior experiences or internal politics should be factored out; it is important to keep your vendor rankings objective, so that any outside animosity does not distract from the software’s capabilities and deployment methods.Following these simple rules will help you to take a process approach to software solution selection.
  12. So I know we covered a lot about the technology and some benefits. When you are looking at the options for technology in your company, it’s important to understand exactly what the cloud truly is and how companies and providers are deploying in the cloud. You also want to understand the different deployment types and what works for your organization. Next, you want understand what’s involved in a cloud deployment, specifically around the tenancy of the solution, the security questions to ask, the value of the cloud and whether it aligns with your company goals, and what you are trying to achieve. Then you want to take a look at your QMS, or any solution for that matter, and see if the cloud is a fit. Do the processes you need work in the cloud, do you want the visibility that you can garner from cloud based deployment, does the cloud technology match your overall needs, and what scalability are you looking to get from your system. Then you can make the determination on whether you want to move your QMS to the cloud and have all the knowledge to make that transition.
  13. There are so many elements to a QMS out there, and you want to find something that fits your budget, and has the full-featured technical capabilities to achieve your business goals. With all the elements, you can get caught up in the details. Here are the core tenets of a good software solution, and what to follow. We’re talking about Flexibility, Deployment, Look and Feel, Reporting, scalability and your end users.
  14. Probably the most important consideration is the ability of the system to adapt to your existing business processes, and be flexible enough to change and improve as your processes change and improve. This may seem like a simple statement, but many times software vendors build their systems around ageneric, best-practices approach that cannot be changed without substantial time and cost. These vendors want you to adapt your processes to their software, not the other way around. If your company has spent years developing and fine-tuning business processes, and upon purchasing a softwaresystem, you find yourself re-engineering your proven processes to fit within the software system’s limitations, you have compromised your efficiency.Do not compromise. Find a solution that is truly flexible and configurable, and can configure all aspects of the software, including workflows, forms, fields,reports, business rules, even the look and feel. Configuration should also be easy for non-technical administrators. Graphical tools such as drag and drop will enable administrators to own the configurations of the system with limited to no programming knowledge required. In many cases, the cost of changing your operations as a result of an inflexible software package outweighs the cost of the package itself. Careful and thoughtful attention to the software’s flexibility is key to a successful implementation.This level of flexibility is often hard to discern with a simple demonstration. Make the vendor dive deep into the product, even configure your existingprocesses for you. Software vendors often take a generic approach to workflow and forms so that they can sell to the “masses.” Many vendors will usually develop the product and “hardcode” certain elements, making it easier to mass-produce, but also making them less flexible. By requesting a “proof of concept” you can uncover any walls in their level of flexibility, and truly see if their software will fit your business needs. Understand whether the configurations are really just configurations, or customizations, which make future maintenance and upgrades much more difficult. Identify howquickly you can make common configurations, like giving different paths through a workflow, adding new sections on the form, defining sub-processes that run in parallel or automating steps in the process. Uncover the number of configuration options to make sure that flexibility is not just skin-deep. Ask the vendor how many of the customers have been able to implement their system without making any code-level customizations.
  15. One of the key areas in today’s technological landscape is the variety of deployment options. There are several ways in which a solution can deploy their solution, and each has it’s own merit. However, each also has a cost associated with it.The first is the traditional model, known as “on-Premises”. This is when a vendor will sell the software solution to the customer, and they will need to install the software into their IT environment, on their hardware. This is beneficial in that you are able to control the location of the solution, and you’ve made an upfront investment, but is often expensive in that you have to make that upfront investment, and also invest in not only the hardware to house it, but the IT resources to support it.The second method is hosting or Co-Location. This is a scenario in which you can purchase the solution and then have the vendor company host it for you, either in their environment or in the cloud. The Cloud is the more beneficial option here, in that it is usually a 3rd party who is in the business of maintaining a robust hosting architecture – you run little risk in the cloud of any downtime. However, like the On-Premises scenario, you may not be incurring cost to maintain the solution and related hardware, but you still are making an upfront investment in a solution.The last is the Software as a Service model, or SaaS. SaaS is a subscription service that enables you to leverage the power of the software solution, with no IT resources and hardware overhead, but you do not actually own the software, you are simply paying for the rights to use it. This is a more cost-effective method for many smaller organization that do not necessarily have the cash reserves for an upfront investment, but it also means you do not own any software. In most cases this is good, because you have a greater level of flexibility in choice of a solution. Without any investment, you are not limited to changing your solution provider, and you can operate a bit more freely without any cost, IT or infrastructure overhead.A quick note about the SaaS deployment – many vendors will offer SaaS at a low-cost because they are putting you on a multi-tenant environment. This is a little prohibitive, simply because a multi-tenant means that multiple companies are sharing the same instance of the solution, most likely in separated databases. This certainly may reduce the cost, but it also reduces your ability to change and configure the solution. You really want to look for a solution that offers a dedicated SaaS environment – this means that you get your own piece of the cloud, with your own personal solution, so you can be unlimited by the level of configuration and flexibility that the solution allows. With a dedicated SaaS environment, you get to have the system you want, without the costs associated with owning and investing in a solution in-house or hosted.
  16. One of the more overlooked issues when selecting the software is the ability to “brand” the system with your organization’s look-and-feel. While many ask whether the system can be configured to meet their changing needs, the ability to change the colors, logos, fonts, and general layout of the navigators,forms and reports is usually an afterthought. Many systems will offer some level of configurability, but this will usually not extend to the layouts themselves. End users must contend with the vendor’s look-and-feel, which will be foreign to them. The ability to control all aspects of the software’s user interface helps user-acceptance of the software, and user buy-in is one of the major contributors to a software implementation’s success. In the age of Web-based applications, vendors can demonstrate flexibility by complying with Web user interface standards. Furthermore, they should be able to provide this controlwithout the need to customize the software. When selecting a system, have a well-defined set of user interface requirements that will make the system work for you, and ensure that the system is able to meet those requirements without having to do extensive development.User buy-in will skyrocket if the system uses familiar colors, layouts and concepts. There are systems in the market that provide 100% configurabilityof the user interface (the presentation layer), so that the system can be modified, without programming, to match the exact user interface standards implemented in other Web-based systems, such as the company’s intranet, or even the company’s external website. The ability to “brand”the system is a critical part of evaluating whether the new system will be a good fit.When looking at how extensively the system’s user interface can be configured, look to systems that provide direct access to the presentation layerusing standard web page design tools. This usually means the ability to change the layout without affecting the software’s functionality. Also, make sure that all aspects of the user interface are configurable, so a consistent look and feel can be implemented throughout.
  17. When you automate using a QMS, there is an enormous amount of data created. Without some means of easily accessing the data, the QMS makes it extremely difficult to derive trends and insights on the quality system. Users are left to their own devices to manually filter out the data, or even export the results into an external system for reporting. This is a time-consuming effort, and can lead to time management issues in finding the data, filtering the data and reporting on the data. Software systems will often offer some means of search capabilities, but this comes in many ways and may require administrative intervention. Having search capabilities is often not enough—the system should be able to search not only at the highest level, but also search on multiple criteria and search within records, or even within attachments embedded in records. At the same time, reporting on the data comes in many flavors. Many software vendors consider reporting an afterthought in the development of their products—usually partnering with third party tools to help make sense of the data, but with only limited integration between the two systems. Others will embed reporting tools directly into their product, providing a more integrated method of pulling data across records within the system. When selecting a software solution, determine the types of searches and types of reports you need to generate, and require that the vendor is able to create such searches and generate the reports you need.Reporting is going to be a driving factor in getting the right information to management. Without the ability to report on the data, and create visibility into Key Performance Indicators, management will be blind. Reports requested by management need to be created quickly, so look for systems that let users create report templates quickly and effectively. Furthermore, make sure the system either has its own proprietary reporting tool, or seamless integration into your existing tools. Often, having systems that outsource reporting to a third party requires a separate license for the reporting tool (Cognos, Crystal Reports, etc.), as well as a steeper learning curve for the administrators and users, which can drive up the cost to purchase the system.Having a robust search is important to the success of a QMS. Many companies leverage the Google philosophy in searching not only the metadata within a record, but also the content stored in attachments. Furthermore, searches should also have the ability to drill down on multiple search criteria (i.e., search or sort within search results), so that results can be filtered. When dealing with thousands of records, this is a critical feature for many organizations. For reporting, the ability to have an integrated reporting tool built into the system is important, not only for ease of use and to eliminate jumping from oneapplication to the next, but to also avoid the administrative costs associated with maintaining and upgrading the third party tools. One test of a truly integrated reporting tool is the ability to go directly from a graphical chart generated by the report tool to the actual quality records representedby the chart, with just a few clicks.
  18. Ultimately, your QMS may not serve a single site, especially if your organization has multiple facilities. As more and more companies scale their systems to span the enterprise, it will become necessary for the QMS to follow suit. When selecting a software system, think about the long-term goals on how youplan to scale. It may not be an immediate need, but having the ability expand your QMS beyond your four walls to include other facilities, or even suppliers and customers can make a difference in the system’s long-term value. Watch out for false scalability promises—some systems will claim scalability, buthave no real experience in the matter. A scalable system must obviously be technically capable of handling the load of additional users, but that is only half of the picture. The scalability of administration is equally important and can be much more expensive to fix later if not considered up-front. Look forcustomer references that have scaled the system to a level that is equal to your business, specifically in the ability to delegate administration to different levels in the organization, across the entire enterprise. Truly scalable systems include location-based administration that extends beyond simply managing different user groups, to enabling location-specific configurations and dynamic filtering of location-specific data.Scalability is an issue often overlooked, since many companies often are concerned with the “here and now.” But factoring in scaling the system beyond a single facility can potentially save your company a good deal of money in the long-term. For example, if you purchase a system that cannot scale beyond your site, and in 2 years you find that other sites are looking to use the QMS, you may have to purchase another system to accommodatethis need, or spend development dollars in forcing the system to scale. Beware of false scalability claims— many vendors believe they can scale the system, but it is never often proven. The concept of scaling a single QMS across multiple facilities is a fairly new trend, and many vendors are not prepared for the task. Technological issues, localization issues, standardizing processes, compiling data from multiple sites for reporting—these are critical factors that must be taken into account when looking to scale a software system.Scalability can be a complex task, requiring multiple facets of integration. Many facilities want to keep their individual processes, but corporate wants to standardize the data for enterprise reporting and process consistency. The ability to implement and administer a system at this level often requires databaseintegration, application integration, and more to make the system consistent across the enterprise. This complex nature of multi-site deployment often leads vendors to create extensive custom development to integrate data, or to find ad-hoc “workarounds” to circumvent a multiple site deployment, such as repository tables, or replication of databases on a scheduled basis, or manual export of site data and manual import into a roll-up database. While thesemay accomplish the task, they fall short of the true goal— real-time collaboration and data visibility. Look for a system that has a centralized administration tool that uses location profiles, user profiles and keyword profiles to standardize elements of the system at a enterprise level. Also look for the ability to configure workflows, forms, and reports by location, so that the unique needs of individual sites or regions can be met without disrupting processes in otherlocations. The benefit is that data is centrally stored, individual sites have access to their data and their processes, and the enterprise is able to collect data across facilities in real-time, creating a truly visible QMS that spans the entire organization.
  19. Typically, the team selecting a software system is made up of multiple areas—IT, Quality, Operations, Purchasing, and more. More often than not, the participants are manager-level, and are making the decision on behalf of themselves and the end users. The end users, while most likely the highest volume user, are more than likely not involved in the ultimate decision. Many software systems will have the technology and process management needed, but once implemented, the end users are lost. It doesn’t look familiar; it doesn’t look and feel right, and requires significant adjustment to get used to. Look and feel may not seem like a “deal breaker” but it can be a hindrance in the learning curve for many users, and cause delays in getting implemented and effective. Many software vendors do not come from your industry. In fact, many come from a technology background, and never take into account the user experience. The result is a software system that is technologically advanced, but completely “un-user friendly.” When selecting a software system, take into account the end user’s experience. Make sure the software can easily be configured to help the end user— whether it is familiar forms and layouts, even colors that match the corporate look. If you are replacing an existing system, see if you cannot match the new system’s look and feel, even the form layouts to the old system. This can make the transition much easier, and make the end users more productive right from the start.Consider the learning curve when you adopt a system for your end users. A system that feels familiar and intuitive can speed time to train and get youremployees productive. When a system is rigid and inflexible in design, user interface and process, your end users will cringe every time they have to use it. They may even reject the system and revert back to old ways. Having a system in place that either matches an existing system, or even familiar Internet fodder (i.e. Google, Yahoo, Amazon, etc) can make users more productive.As stated before, many software vendors come from a development background—they probably have never set foot on a shop floor, interacted with typical end users or understood the very processes they were developing. Look for vendors that have a background beyond development. Vendors that come from Quality and compliance know quality and compliance, plain and simple. Furthermore, make sure the system has the backend tools necessary to adopt a familiar look and feel. Simple style sheets and configurable layouts can make the difference. Silly as it may seem, changing colors and graphics on a QMS can enhance the end user experience, and provide an environment for better productivity