The Lab Manager INFORMATICS RESOURCE GUIDE Things to Think About Before Buying a Lab Informatics System BY RYAN ACKERMAN Considering the Cloud BY JOHN JOYCE, PhD LIMS: Flexible Data Management BY MIKE MAY, PhD 20 To LIMS or Not to LIMS? 17 BY ANGELO DEPALMA, PhD Product Focus: Electronic Laboratory Notebooks BY ANGELO DEPALMA, PhD Informatics Resource Guide 2017 Things to Think About Before Buying a Lab Informatics System Modern informatics systems come in a variety of different types and configurations to suit any researcher’s needs By Ryan Ackerman A LABORATORY INFORMATICS INTEGRATION TIP When integrating a new informatics solution into your lab, one thing you’ll want to make sure of is that the variety of instruments in your lab will be compatible with the new software. Make a list of your lab’s equipment and do your research to make sure it will work with the new informatics platform before you start. How does the scale (size, people, and processes) How will increases in scope or scale determine affect the ideal informatics set-up? which informatics system should be used? Modern informatics systems come in a variety of different types and Increases in scope or scale can bring up many fears for most configurations to suit any researcher’s needs. If you are part of a small laboratories. Failing to meet compliance, having a system which is research lab that works out of a single location with only a few tests, no longer fit for the purpose, or having an informatics system which using a hardware-based solution may be best. This allows you to more can no longer handle the amount of data are a few. Researching to easily troubleshoot the hardware and keep the data safe on-site. For see if the system is capable of being customized or upgraded to much larger laboratories which incorporate more processes, business accommodate these changes is important. lines, and employees in a global setting, there are a variety of options available, including software-based platforms. Many vendors can offer customizable solutions for a laboratory’s needs, such as the ability to translate between languages. How will the need for significant travel or accessibility influence which informatics system is best? As the needs for laboratories to connect with each other across great distances increases, many researchers are finding that the need to travel has also grown. As a result, having 24/7 access to your informatics systems has become crucial. With the advent of cloud- based data storage, this has become easier than ever. Many informatics systems offer such storage options, even allowing the informatics system to be completely web-based. With this option, you can access all of your research data anywhere an Internet connection is available. Lab Manager 2017 2 LabManager.com Informatics Resource Guide 2017 Considering the Cloud Despite all the hype being tossed around, the cloud is a logical evolution of previous systems. By John Joyce, PhD When considering the cloud to host the data system for either a clinical or a chemical laboratory, there are additional factors that you must consider: • First, and perhaps most important, is the laboratory you are attempting to automate one that is required to conform to GXP regulations? If so, you must consider how these regulations affect your ability to take advantage of the cloud. Exactly which regulations are relevant depends on your type of laboratory, the objective of the laboratory, where it is, and where it ships products. Additionally, this evaluation must be done before signing a contract and implementing a system, or you are just begging for an inspector to start issuing citations. Data Protection, System Maintenance, and GXP • How is your data acquired? Do you anticipate controlling Compliance Are Just the Beginning instruments through this cloud system? Is this control time- sensitive? The term “cloud computing” reputedly came from the common use on flowcharts of a cloudlike symbol to represent the Internet. • How is validation of your system maintained? This issue is In common usage, “the cloud” is a very loosely defined term. The tightly coupled with the issue of how change control is handled cloud can be used to store data, as a backup medium, as a processing and who handles it. platform, and in any number of other ways. The National Institute of Standards and Technology has a much more specific definition • How do you go about auditing this cloud data system? Can you of what cloud computing is, but many people use the term much gain access to the data center to perform the audit— or even more broadly—and actually, a significant portion of people do not determine where the data is actually stored?1 understand it at all. One of the cloud’s main features is its elasticity. This simply means that as your memory or processing needs change, A very good introduction to these issues, particularly regarding the system can automatically adjust its resources to your requirements. the regulatory impact, can be found in the writings of Dr. R. D. McDowall,2 a highly respected expert in the field of automated Despite all the hype being tossed around, the cloud is simply a logical laboratory system validation. In his evaluation, McDowell eliminates a evolution of previous systems. Because of its elasticity, it is frequently variety of unsuitable cloud configurations, but concludes that a SaaS preferred for processes during which the computing or storage system—where each customer is running its own instance of the demands can change significantly and suddenly. With the cloud, application with its own database, in its own virtual machine—does you have to pay for only the resources that you actually use. You do have advantages for the customer. Cloud latency can be addressed not have to purchase hardware capable of handling your maximum using a local interface box to actually collect data and control processing or memory load. This frequently allows you to launch instruments. prototype projects for evaluation that you would never get approved if you had to purchase all of the equipment. You will frequently find One of the major factors you have to accept when using the cloud, the cloud used with so-called big data projects, but other applications no matter your purpose, is that your data is passing outside of your using the cloud include Gmail and similar services. control and you must trust your cloud provider to protect it. For some Lab Manager 2017 3 LabManager.com Informatics Resource Guide 2017 users this is untenable; others find ways to live with it. This is one of mundane things such as who is responsible for backing up the system, the reasons you want to vet your cloud supplier very carefully and to how the system is backed up, and how the company confirms that validate its procedures as much as possible. Two critical procedures to this backup has been done and is functional. Note that while some start with are the way data is transferred and the way the application existing SLAs might cover availability to the application on the virtual program interface (API) works, as this is your portal into the cloud. If machine, they don’t necessarily guarantee access to the data or accept your data is not encrypted while being transferred, it’s time to look for liability for any data lost.1 another vendor immediately. The API should also be secure, requiring identity verification before executing any process. When the data is There is one additional issue you should be aware of when making not actually being used, the best practice is to keep it encrypted. the decision as to which type of cloud to use, if any. This issue doesn’t actually address whether your data has been exposed or not—just When considering, implementing, or using a cloudbased data system, whether you are aware of it. While your cloud provider might encrypt it is expedient to be on good terms with your organization’s IT group, all of your data and pledge not to release the encryption keys, thanks as they can supply vital input into items to consider when generating to the Patriot Act (with the obvious inference that anybody who a service level agreement (SLA) and contract for the system. To be objects to it is unpatriotic) and associated laws, the federal government blunt, this can sometimes be a ticklish interaction that may put your needs only to send your provider a national security letter (NSL)3 management and negotiating skills to the test. The important thing is demanding whatever they want, even if it is your entire database: that the intent of both sides is to successfully implement the project, “They do not require prior approval from a judge, only the assertion not to make it something that they can leverage others with. that the information demanded is relevant to a national-security investigation.” 4 Even better, this letter usually includes a gag order For IT to be willing to trust that everyone involved knows what that makes it a crime for the cloud provider even to admit that it has they are talking about, it helps if you have personnel with sufficient received an NSL, let alone to notify the affected customer. This makes computer expertise and, ideally, experience working with the IT it possible to siphon off your data without your even being aware of staff. It is also important to get the IT team involved early in the it. Admittedly, the government could send the letter to you directly, process, as they generally control the network infrastructure and the but then you would know what they were doing.