• John Jones answered to the question “Archiving LIMS data1 week, 2 days ago

    From our experience as a LIMS vendor, we have had to deal with this with most every regulated client we have. The system grows and grows and there are several reasons for needing to archive data: 1. System Performance 2. Written policies on data archives as driven by management and regulatory compliance. 3. Rarely, if ever by cost Disk space is cheap in the cloud or on-premise. While cost used to be a reason in the past, it is no longer. So the only real reasons from our perspective is items 1 and 2 above. The approach we have taken for both cases and to handle Disaster Recovery is to use a series of backup technologies to begin with. First, we have hourly incremental backups of the system so that we can roll back at any 1 hour increment within a rolling 24 hour period. This means we have 24 backup points to roll back to. Next we keep daily snapshots of the system and keep those for 90 rolling days. This allows us to pull up and restore and operate independently up to 90 daily version of the system. Using this approach alone covers item 2 nicely. The LIMS of course must be regulatory compliant in the first place in terms of authentication, electronic sigs and audit trails. All of that is captured in that case in the hourly incremental and daily snapshots. Now to Archiving of data…. That is highly bespoke. Even with our COTS LIMS, the implementation for each client is different and so how the data is managed and used is highly client dependent. In this case we do not have a one size fits all solution. It is entirely driven around the QA department’s policies and procedures and they build those policies around not just the regulations but their actual business requirements. Regulators do not tell you how to run your business, they tell you in general terms what regulations you must comply with. Regulations are written by subject matter expert lawyers and they write statutes and rules based around the constraints of State and Federal laws. They cannot overreach or they risk a smack down with a powerful law suit. In summary, they write the rules to be vague so as to allow the regulated entity latitude in what they do but within the boundaries of the law and statutes. This means that you have latitude with respect to your archiving of data and in the matter of a regulatory investigation to assure that your data is both accurate and complete, the Disaster Recovery approach described above will yield a lot of great forensic data at the disk block level and higher.

  • John Jones answered to the question “Archiving LIMS data1 week, 3 days ago

    Heather that is a great and thoughtful question. There are a number of good technical approaches. I will follow-on with comments and suggestions in a subsequent response below. Stay tuned.

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  • Sarah, there is a lot of content to pull from the limsforum and post on your site. You just have to publish using the creative commons license that the content is licensed under. You will find that license in the footer of this site. There are tons of Cannabis articles to choose from.

  • John Jones answered to the question “Enviornmental Monitoring2 months ago

    Rakesh, there are different types of environmental monitoring. Because you mention 21 CFR part 11, I make the assumption that it is for pharma manufacturing. If that is the case then the following LIMS vendors will be a good starting point: 1. LabLynx (I work there) 2. Thermo Fisher 3. Starlims 4. Autoscribe There are more but you will want to start with these. If it is environmental monitoring in classic environmental testing like municipal water/waste water then the following LIMS are a good choice. 1. LabLynx 2. Autoscribe 3. Promium 4. Chemware Please elaborate on your requirements and hopefully the vendors will jump in with elaboration on how their products can help. This discussion is open freely for discussion on products to help our members learn about what is available and possible.

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  • John Jones posted an update in the group Public Health 2 months, 4 weeks ago

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  • The particular regulatory requirements are dependent on the type of lab that you are talking about. The regs that apply to a clinical lab are different from that of an environmental and are different still from a pharmaceutical QC lab and different still from Pharma R&D. Please elaborate on the type of lab you are asking about. Also keep in mind that there are a number of regulatory requirements that will cut across all types of labs such as GDPR and any EU / UK cybersecurity standards that may represent best practices but are not a regulatory requirement. One other thing to consider is the impact of brexit on the UK market. That is very much up in the air.

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  • John Jones posted an update in the group Oil Analysis Talk 3 months, 1 week ago

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  • John Jones posted a new activity comment 3 months, 2 weeks ago

    In reply to: Kiran Ganda posted an update in the group Healthcare Diagnostics A new article in Medical Laboratory Observer highlights the critical role labs play in furthering population health and value-based care. With […] View

    I read the article and found the proposition interesting but a lot of questions are left unanswered. Like all businesses, labs make a profit by paying less than what they take in. The theory and ideal of performance based payment sounds good at a high level but the devil is in the details. Labs have a lot of fixed costs and costs based upon the tests performed. How will outcomes be measured such that the lab gets its fair share of the positive outcome payment? That was not addressed.

    I think the one way for this to work is for the lab to make money as it currently does but to share its data in a central repository that is hipaa compliant but allows the overall health ecosystem make use of the data to improve population healthcare results. The data contributors (labs) gain income based upon the amount of data they share to the pool. The central repository could be owned by the lab stakeholders and operated by a 3rd party service organization much the way the music industry operates for music licensing. This model will get the labs paid for the work they do plus give them an upside for performance based results from sharing their data in a license model.

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  • John Jones posted an update in the group Medical Devices 3 months, 3 weeks ago

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  • I have found that from an internal IT staff point of view, they love the change from client installs to a server based install with the app running through the browser. With respect to the users, the satisfaction levels are mixed. If the LIMS has a modern, responsive design then the acceptance goes up. When the users can look at info through mobile devices and approve results through web access through the phone, you will find the users very accepting of that. The key is a modern responsive UI.

  • I have implemented many, many LIMS in the public sector and I appreciate the question you are asking. First, the public sector is significantly different from the private sector and it reflects down to every level and throughout the organization when it comes to personnel. Public Sector is pretty anathema to change for the most part. Staff are well established and do not move for the most part from my experience. Procedures and policies are built to resist change. I have rarely found change in staff going from one system to the next. The public sector is driven entirely around a fixed budget and personnel expansion is resisted and rules and regulations prevent involuntary change to personnel quantity or scope. Basically, we have found for the most part that change is not desired or wanted except by political appointees which are temporary. The permanent staff will resist change unless it will reduce work without reducing costs or staff. The vendor supplying a replacement system needs to understand the fundamental realities of this type of organization and basically provide a replacement system that cuts work down for the users without cutting down or giving management the opportunity to reduce staff. That will be a successful system from the users point of view and a frustration for the political appointee unless that appointee could care less and is simply there for the money and power goodies. This all sounds pretty cynical, I know but it is a reality I have seen repeated dozens of times. When I have fought it, I lost money and and goodwill. When I embraced it, the project completed successfully and those in a permanent position were happy. Summary… Go with the flow, do not disrupt and give the users what they already have but in a new system and call the job done. As for changing staff or reducing staff, that is basically a non-starter. Provide plenty of training opportunities so that it gives staff a reason to do something different from their regular work-a-day drudgery. They will love the system and embrace it if you do these simple non-disruptive things.

  • John Jones posted an update in the group Life Science Research 4 months, 1 week ago

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