Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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====3.4.2 What this means for the lab====
So you've looked at what adding a [[laboratory informatics]] solution to your [[cannabis]] testing [[laboratory]] can do for you and your [[workflow]], and you're now considering a [[laboratory information management system]] (LIMS) for your lab. This can be an intimidating step, particularly if you have little in the way of in-house expertise in integrating informatics into the lab. How expensive will it be? What are the differences between adding an on-premises solution vs. a cloud solution? How difficult will it be to learn the system? What if the implementation goes wrong, costing even more? Will we really see any added benefit to adding a LIMS to the lab? These and other questions may fearfully get asked as you and your team venture forth into unfamiliar territory. However, know that you won't be the first lab to take this step, and you won't be the last. Stable LIMS vendors with personnel representing decades of experience have assisted labs of all types with these and other questions time and time again, and the best vendors will have the added industry-specific experience to understand and tailor LIMS selection and implementation to the nuances of your lab.
[[File:Logo der ISO.svg|right|200px]]While many cannabis testing laboratories won't be handling medical marijuana patient information, let alone dispensary sales information, lab managers must consider the data privacy issues of those realms and relate them to the data and workflows of the cannabis testing lab. What data must be protected? What standards must be followed to ensure that data's protection?


Take for example ISO/IEC 17025:2017, item 8.4.2, which requires a lab to have "controls" in place "for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records."<ref name="KramerISOIEC20">{{cite web |url=https://www.pjlabs.com/downloads/webinar_slides/4.20.2020_Doc-Control-Records.pdf |format=PDF |title=ISO/IEC 17025:2017 Requirements Concerning Document Control and Control of Records |author=Kramer, M. |publisher=Perry Johnson Laboratory Accreditation, Inc |date=20 April 2020 |accessdate=07 July 2021}}</ref> The long-term implication here is that data should be clearly identified, ''securely'' stored, backed up and archived, and have clear information about their retention and disposal. The data should be thoughtfully "controlled" so it doesn't get lost or fall into the wrong people's hands. This is further evidenced by ISO/IEC 17025:2017, item 7.11.3, which calls for the data to be "protected from unauthorized access" and "safeguarded against tampering and loss."<ref name="ShimadzuISOIEC">{{cite web |url=https://www.shimadzu.eu/sites/shimadzu.seg/files/SEG/Landingpages/DataIntegrity/SEG_4547_Whitepaper_ISO_v7_OK.pdf |format=PDF |title=ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories |publisher=Shimadzu Europa |accessdate=07 July 2021}}</ref>
That said, you won't be relying solely on a vendor to walk you through every step of the process. The cannabis testing industry inevitably places demands on the laboratory manager and its staff to know and follow the standards, regulations, and accreditation procedures associated with the industry. Your lab should have already met or is on the way to meeting those demands, nearly set to take on new challenges, including integrating a LIMS into your lab's workflow. While the vendor and related consultants can provide vital help in the overall process, a chunk of the onus will fall on you and your team. That means understanding your business' mission, goals, budget, in-house knowledge, and procedures, as well as basic information about software acquisition, implementation, and maintenance, both short- and long-term. And, of course, you'll want to know more about the significant vendors providing clear information about how their LIMS meets the needs of a cannabis testing lab. This is often achieved by either contacting vendors directly and asking for details, or by submitting a request for information (RFI; more on that later) that attempts to draw in vendors to respond with more information about their LIMS and how it solves your lab's problems. This chapter will help guide you on that journey.
 
As such, it's obvious that cannabis testing labs, at a minimum, have to take data privacy and management seriously to stay in step with the ISO/IEC 17025 standard. That of course doesn't take into consideration any regulatory requirements for chain of custody and certificates of authority to be preserved by the lab for a specific period of time, nor does it account for any proprietary methods and business details that could potentially harm a lab in the wrong hands. Just like the personal health information of medical marijuana patients, and like the customer information of dispensaries, cannabis testing labs are charged with ensuring the security and privacy of the data they collect and manage.
 
To meet those requirements and more, a LIMS that includes functionality that helps labs support ISO/IEC 17025:2017, NELAC, ELAP, and Patient Focused Certification (PFC) requirements makes for a wise investment. Cannabis testing workflows can be difficult, as is the management of associated analytical instruments and their data. Throw in the complication of a semi-fractured regulatory atmosphere, and the cannabis testing lab is forced to operate with tight, enforced procedures to ensure not only the quality of tested cannabis substances but also the chain of custody of samples that come into the lab's possession. A LIMS that can carefully and automatically collect, manage, track, retain, and archive operational data—as well as the audit trails associated with those activities—is required to better maintain the security and privacy of that data, as well as the long-term viability of the lab.<ref name="AudinoManag18">{{cite web |url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ |title=Managing Cannabis Testing Lab Workflows Using LIMS |author=Audino, S. |work=Cannabis Industry Journal |date=07 February 2018 |accessdate=07 July 2021}}</ref>
 
==References==
{{Reflist|colwidth=30em}}

Revision as of 17:49, 19 August 2021

So you've looked at what adding a laboratory informatics solution to your cannabis testing laboratory can do for you and your workflow, and you're now considering a laboratory information management system (LIMS) for your lab. This can be an intimidating step, particularly if you have little in the way of in-house expertise in integrating informatics into the lab. How expensive will it be? What are the differences between adding an on-premises solution vs. a cloud solution? How difficult will it be to learn the system? What if the implementation goes wrong, costing even more? Will we really see any added benefit to adding a LIMS to the lab? These and other questions may fearfully get asked as you and your team venture forth into unfamiliar territory. However, know that you won't be the first lab to take this step, and you won't be the last. Stable LIMS vendors with personnel representing decades of experience have assisted labs of all types with these and other questions time and time again, and the best vendors will have the added industry-specific experience to understand and tailor LIMS selection and implementation to the nuances of your lab.

That said, you won't be relying solely on a vendor to walk you through every step of the process. The cannabis testing industry inevitably places demands on the laboratory manager and its staff to know and follow the standards, regulations, and accreditation procedures associated with the industry. Your lab should have already met or is on the way to meeting those demands, nearly set to take on new challenges, including integrating a LIMS into your lab's workflow. While the vendor and related consultants can provide vital help in the overall process, a chunk of the onus will fall on you and your team. That means understanding your business' mission, goals, budget, in-house knowledge, and procedures, as well as basic information about software acquisition, implementation, and maintenance, both short- and long-term. And, of course, you'll want to know more about the significant vendors providing clear information about how their LIMS meets the needs of a cannabis testing lab. This is often achieved by either contacting vendors directly and asking for details, or by submitting a request for information (RFI; more on that later) that attempts to draw in vendors to respond with more information about their LIMS and how it solves your lab's problems. This chapter will help guide you on that journey.