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Lyon
Apr 17, 2003
Do any of you guys work in water/waste water laboratories? I've basically been tasked with entering the water/waste water market (LIMS) for my company and I'm trying to figure out where to start. This would also extend into larger scale environmental labs such as state level EPAs etc. I would love to have a quick conversation with any of you who work in this area.

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Lyon
Apr 17, 2003

Dik Hz posted:

Anyone else going to PittCon?

Is anyone else attending this year? I'll be there Sunday-Thursday sitting at our booth in the informatics section but am definitely up for grabbing some beers with any goons who happen to be there.

Lyon
Apr 17, 2003

C-Euro posted:

This probably isn't lab-specific but here goes- yesterday my supervisor calls me into his office to ask my opinion on some new metrics we're implementing, and during the discussion he casually starts asking me what I think about learning some of the QA side of things in our department (since our "Quality department" is a mashup of more traditional QC/QA/auditing/safety etc. departments elsewhere). I tell him I'm happy to learn as much as I can and forget about it, as according to him it's dependent on getting a LIMS setup in place this year and needing fewer hands for manual data entry and doc creation (but :lol: at my department having the spare capital for LIMS) Then today one of our main QA guys announces his two weeks' to our group and I'm starting to wonder if my supervisor has an idea to groom me for that role once the other guy leaves.

Here's the rub- unless something completely crazy happens it's likely that I'll be leaving the company soon, either when my fiancee takes a postdoc out west or she gets a job around here that gives us enough income and a better location where I can look for other work (I haven't been happy at my current position for a few months now and the department that I want to be in isn't hiring anytime soon). Am I a dick if I agree to be groomed for this more QA-heavy role and then bail partway through learning it, or is that just the risk all employees carry? At this point I've learned everything I can about my current role and most of my motivation for learning new things elsewhere at work is "will this look good on a resume/in an interview?" When I was whining about being trapped in quality a couple of you said that QA experience translates well across industries, and having that highly relevant skillset would be my main motivation to learn it rather than having a career that's strictly in quality. Maybe it won't pan out before we have to move and this will all be moot, but if I am being trained for this role while getting ready to leave should I be upfront with my boss about putting their long-term training investment elsewhere, or should I stop worrying and look out for #1?

I would say look out for yourself. What if you don't end up moving elsewhere? Now you'll be stuck in the job you're not happy with and resentful you didn't take this potential role. If/when you get confirmation that you will be moving let your boss know, don't just surprise him, but for now I would take the role and not mention a word of the move.

Also send me your boss's name and number, I sell LIMS hah.

Lyon
Apr 17, 2003

Sundae posted:

Lyon - you don't happen to know anything about Catalyst LIMS, do you? Like, whether or not there are any 21 CFR Part 11 compliant plugins that work with modern statistical packages for it? Per our SOPs, we currently have to print all the data, manually transcribe it into Minitab, perform a multi-person audit/verification of data against the source documents on the screen since we haven't validated the printing process from Catalyst, then audit the Minitab spreadsheet against the source as well to confirm that we didn't transcribe something incorrectly again.

Ideally we'd just fix our loving SOPs, but it's probably more realistic for us to throw money at a proper export plugin and save the transcription steps than to fix any SOPs around here.

I'm not aware of any pre-validated plugins offered by Accelrys but drug development/design is not a space I'm very familiar with.

It sounds like they have an export function but you are unable to use it because it hasn't been validated? Could you hire a consultant to validate the export piece and just use their standard export functionality? If the scope of the validation is limited I'm guessing it wouldn't be that expensive.

There is a really good LIMS consulting firm based out of Newark, DE called CSols and another one based out of New Jersey named Astrix (disclaimer: we farm our validation work to Astrix). They both perform system validations and CSols is very well known in the industry.

Lyon
Apr 17, 2003
Anyone at PittCon? I'm over in the laboratory informatics section sitting in our booth. If there are enough people here we could have an impromptu goon meet and grab some beers.

Lyon
Apr 17, 2003

Dik Hz posted:

I'm down. I'm at PittCon staying in the French Quarter.

We are at the Marriott across the street because we are lazy and love hotel points/status.

You don't have PMs but you can email me at ecksile at gmail and I'll be in touch. If you are on the floor tomorrow I'm at 2937 in the informatics section and my name is Dave. I'm the youngest guy there by a mile so I'm stuck at the booth all day but should be relatively easy to find.

Lyon
Apr 17, 2003

C-Euro posted:

Here's a new one- it appears someone has been re-filling our acetone wash bottles with stock bottles we keep in our flammables cabinet, and then putting the empty stock bottles BACK into the flammables cabinet, so no one could tell that we were out of acetone until we pulled the stock bottles out and saw that they were all empty :negative: How did I end up working with some many dummies, and what does that say about me? So glad that I get to give notice today (which I was going to do before I found out this bottle issue), now does anyone in Philadelphia want to give me a job?

What's your masters in? There is a lot of pharma in the area and I have friends who work for GSK, Pfizer (not sure if they do research out this way or not), Merck, etc.

You could always ask Sundae if I remember correctly... though if you follow BFC I think you'll probably want to avoid that...

Lyon
Apr 17, 2003
Whoever signed the validation documentation should be liable no? Essentially it is just a series of IQ, OQ, and PQ scripts that need to be written and executed. Typically the vendor can provide the installation qualification and operational qualification scripts (though I think IQ may have been replaced with installation verification in most cases). This sounds like it would fall under PQ (performance qualification) which is based on the performance requirements in the URS. Sounds like someone at Sundae's place either wrote bad PQ scripts or didn't actually execute them properly. So there should be someone who this failure can be traced back to but depends on if they are still with the company, if they are untouchable execs now, or just generally how corporate reacts to the news. Hope it works out okay for you but if I remember correctly you're not liable for any repayment if they fire you and you're almost out anyway right?

Lyon
Apr 17, 2003

Solkanar512 posted:

What are you confused about here? I did in house calibration (ISO 17025) for several years so can answer questions about this.

ISO 17025 certification is different from being required to validate your computer systems. 17025 certification typically requires a data management system and proof that you're competent. A lot of contract testing laboratories are 17025 certified but don't have validated computer system requirements. The FDA requires validated systems within certain industries (e.g. pharmaceutical manufacturing); though if I remember you came from Food and Beverage which often falls under the same basic validation requirements as pharma.

Validated systems require running the validation scripts (let's focus on PQ scripts) that prove a system is outputting the correct results as defined by the user requirement specification. We might write a script to validate an addition function by saying we expect 2 + 2 = 4 and then testing it. If we enter 2 and 2 to the addition function and get back 4 then we can sign off on that functionality.

Someone at Sundae's place either messed up writing the validation script or messed up executing the script (or knowing pharma there is a more nefarious explanation).

Lyon
Apr 17, 2003
Just a reminder that if anyone ever needs a LIMS I'll be happy to sell you one :). Also saying the word LIMS will always summon me to this thread like Beetlejuice hahhhhh.

Lyon
Apr 17, 2003
I wonder if you're a customer of ours... we resell MODA to a lot of our pharmaceutical customers. Although if you were a customer of ours we probably would have gone in the other direction and sold LIMS first and then MODA.

Lyon
Apr 17, 2003
My company has open positions for business analysts, project managers, and one technical training specialist. We sell laboratory information management systems (LIMS) so if you're looking to jump from the lab to a software company we might be a good fit.

Pay depends on experience but I'm guessing probably 60-90k would be a decent guess at the range. No idea on any real specifics though.

We used to hire people from anywhere but there has recently been an emphasis on hiring in the NJ/NY/PA area rather than fully remote locations. However if you are interested I will gladly submit resumes even if you are remote and we can see how our CEO is feeling this week. PM me if you have any questions or want to submit a resume.

Lyon
Apr 17, 2003

Johnny Truant posted:

That moment where your IT department says they restored all your accessioned freezer sample databases only to find out that they restored everything... but only up to four months ago. Oh, and the restoration was spotty so they recommend a full audit on all our samples. :suicide:

Damnnnnn that sucks. Are you working with human samples (I typically see the word accessioned used by our bio banking/cancer research customers)? Hopefully not because if you that's going to be extra brutal. How many freezers/samples are we talking about here?

Lyon
Apr 17, 2003
Not sure if anyone was interested but Big Pharma Game was released at some point, https://www.bigpharmagame.com.

Lyon
Apr 17, 2003

Bastard Tetris posted:

I miss having a stupidly high Capex budget.

Then again I'm getting an eight figure budget to build my new core, so at least there's that.

Spend some of that budget on a new LIMS from your friendly local goon LIMS vendor!

Lyon
Apr 17, 2003
Who will be at Pittcon this week? I'm flying in today and will be there until Thursday. I'll be standing in the informatics section all week selling LIMS and LIMS accessories.

Most nights I have to go out with my co-workers but if anyone wants to organize and little meet up I'd probably be in.

Lyon
Apr 17, 2003
PSA (public sales announcement): Buy a LIMS and consolidate all your sample and reagent data into one application! Track instrument and analyst certifications! Integrate your complex and simple instruments to get rid of time consuming transcription and reduce errors! Easily generate reports! And more!

Lyon
Apr 17, 2003

Bastard Tetris posted:

I'm trying to get end-to-end LIMS/sample tracking in our whole automated workflow set up but I really really really don't want to be the person in charge of it. God I hate being Captain Capex at work sometimes.

I legitimately work for one of the top two LIMS vendors in the world if you have any questions. My experience is more on the QC manufacturing side of things but we also have a massive segment of customers in pharma (specialized qc/r&d), life science (I guess I mean specimen banking and sequencing and all that fun stuff), academic research, etc.

I do a mixture of sales and training since our training department is wildly understaffed and that's my background so if I can provide any info to anyone in the thread let me know. One day I will sell a LIMS to a goon and my life will be complete.

Lyon
Apr 17, 2003

robotoilet posted:

We just had a staff meeting at the bloodbank where I work and accounting / upper management has decided to switch around our hours. Secondshift (what I'm on now) is going from 3pm to midnight to 6 or 7pm to 3/430 am. In addition, every other week I will be on call every day from 0500 am to 4pm or so and have to work a double shift if they call me in. This is pretty loving bad, so I'm looking to jump ship as soon as I can.

Has anyone ever gone from bench work to more of the LIS side of things? I'm thinking about making a career move but I'm not sure what certs I need to grab. The few LIS/LIMS admins I have talked to said they got into the position mostly by luck (right place right time, telling their boss they like computers).

DID SOMEONE SAY LIMS??? *Kramers through door*

Unfortunately becoming the LIS/LIMS admin is typically right time right place. If you don't become the LIS/LIMS administrator internally to gain some LIS/LIMS experience then it can be difficult to acquire. First you would have to gamble on purchasing training from a particular LIS/LIMS vendor of which there are a few hundred. You could then attempt to apply for any LIS/LIMS job and say you have relevant experience but that's still a risk. Second, my company has a strict policy of only training current customers (and very very grudgingly contractors hired by those customers) so you wouldn't even be able to sign up for a training with my company. I'm not 100% sure how common that is at other LIS/LIMS vendors but we are one of the top two LIMS vendors (#2 obviously :P) in the country.

You could look for job postings for LIS/LIMS administrators in your area and see if they will hire you without a lot of LIS/LIMS experience or another option would be to apply directly to work for a LIMS vendor. We prefer to hire customers/former customers because they have lab experience and experience with our software but we also hire people directly from the lab a lot too. Probably the most lacking thing in our organization is people who truly understand the lab space and have experience with the problems we are trying to solve (although we've been getting better about this). A lot of the lab people we hire view working for a LIS/LIMS vendor as an intermediate step, it gets them out of the lab and gets them experience with LIS/LIMS software and also with project management (typically we hire lab folks to work as business analysts).

Lyon
Apr 17, 2003

DemeaninDemon posted:

Oh right we don't use ISO classification. It's ISO class 4. Full smock, hoods, and booties+ ground.

It's semiconductor manufacturing.

I just visited a couple semiconductor manufacturing sites. Crazy stuff. The groups I was talking to don't appear to be doing much "traditional" chemistry other than testing their chemicals. Mostly SEM and some TEM testing. Honestly though I have no idea what they're doing at the production line as we are working with their labs that test failures and customer issues/complaints.

Do you work in production? I'd love to hear what a standard day looks like.

Lyon
Apr 17, 2003
If anyone wants to know more about (or buy :)) LIMS/ELN/LES, this is my annual reminder to the thread that I work for one of the "tier 1" LIMS vendors.

Lyon
Apr 17, 2003

Sundae posted:

Do you do electronic batch record software with CFR compliance for systems validation and data integrity by any chance?

Typically the data stored in a LIMS is used as part of the batch record but the LIMS data is not complete enough to actually generate the batch record itself. I am not an expert on the exact contents/requirements for a batch record but based on this link most of the information needed for generating the batch record would be coming from the ERP (and a small amount from supporting applications like the LIMS and the document management system). Assuming that the LIMS to ERP interface transferred the results from the LIMS to the ERP for the batch/batch stage testing then a customer would not need to pull data from the LIMS themselves since the interface would have already transferred it to the ERP.

We do provide a pre-configured and pre-validated LIMS for pharmaceutical manufacturing. We configured the LIMS and then validated the system using GAMP 5/a risk based approach. We include all of validation documentation in both executed and unexecuted format so things like the URS, IQ, OQ, PQ, Traceability Matrix, SOPs, etc. are all included in the package. If a customer is using the LIMS as designed then all they need to do is create a validation wrapper and a few other actions that are required such as auditing the vendor (depending on the level of risk you can accept anyway, some customers re-execute the scripts or create additional scripts etc etc).

Our product could theoretically be extended to capture all of the necessary data to generate a batch record but the amount of configuration, customization, and additional validation would most likely make the project so expensive that it would never get approved. We focus on providing the best platform for managing the laboratory process flows and data rather than trying to become a Frankenstein creature of ERP, LIMS, QMS, etc.

Lyon fucked around with this message at 21:01 on Jul 21, 2017

Lyon
Apr 17, 2003

Cardiac posted:

How do they deal with various types of data format as in everything from genes to protein structure determination?
How easy is it to copy to and from the LIMS and is it fully Mac compatible?
Is the pricing fixed or based on number of users?
We have one ELN at the company, but it is rather restricted for what we do. We are mainly doing R&D and not QA.

For these questions I can really only answer specifically about my company's product but most of our competitors have similar setups.

  1. Typically the LIMS is going to record "structured" data where you know (to some degree) what you're looking for. For instance when talking about manufacturing you're going to know the methods you'll be running against a product or sample type. So I know that I test this product for pH, loss on drying, and whatever main assay and I check those results against the product specification. For data being collected in labs that work on DNA sequencing/genomics/proteomics we are typically going to record specific/key data points the laboratory is interested in after you process the massive instrument result files. Did their DNA express some specific gene? What was the optical density of the DNA and is it within the acceptable range for use? Things of that nature and then we can link the results we recorded back to the instrument result file/analysis file. We have two sales reps who specifically work in life sciences (not including standard pharma, we all do pharma) and I am not one of them so I'm not an expert on how we are recording all of the relevant information. I sent the one a message but it's after 4 on a Friday so...

    For unstructured research data you can cram anything you want into the ELN. We will still shy away from storing the massive instrument result files directly in our database as they can be gigabytes of data but we will reference them from the ELN the same way we do in the LIMS. You can record text, images, chemical formulas, video, spreadsheet data, charts/graphs, incorporate data from the LIMS, etc. within the ELN.

  2. Our data entry grids you can copy to and from Excel/spreadsheets very easily but for most of the other screens we would probably tell you to just use the export to Excel/CSV capabilities rather than trying to copy paste the data from the page due to formatting issues (HTML can do funky stuff depending on where you are pasting it to). We are 100% web based so end users only need a browser, no thick client or Applets/ActiveX/Flash, and we support IE11, Edge, Chrome, and Safari so our LIMS should be able to run on any device that you prefer.

  3. Software cost is based on the # of users and modules. Services are typically an up front cost to configure the system to your requirements/process flow and typically involve things like modifying the out of the box behavior, integrate instruments to the LIMS, create reports, interface to other systems, etc. After the system is up and running you own it and can modify it however you'd like or you can always purchase more services from us and then we will do whatever work you want.

  4. There are varying levels of ELN and some are built primarily for QC rather than R&D so depending on what ELN your company purchased and how it was configured they may be shoehorning your group into an ELN that wasn't designed for R&D.

Sundae posted:

Thanks for the honest answer. I appreciate it. :)

I'm in early stages of putting together documentation automation processes for our GMP clinical manufacturing area and figured I'd ask.

Well if you need a LIMS have I got a deal for you ;).

Lyon
Apr 17, 2003
Did anyone go to Pittcon this year? I don't see us (a LIMS/ELN vendor) attending Pittcon for too much longer. Honestly the only reason we still do it is because our #1 competitor is there and it would look bad from a marketing perspective. We joked about a gentlemen's agreement to both reduce our presence next year because sending 15 people and spending $50k on a giant booth is stupid. The internet has really destroyed trade shows but doubly so for informatics/software. I also hate Orlando. Next year is Philadelphia which annoys me because I'm local but at least it's a walkable city with non chain restaurant options.

Phosphene posted:

Time for more tales of Food Chemistry:
The SOP clearly states: weigh x grams into crucible
Add y mls of acid to sample + crucible
Place crucible in 500C furnace for a while, cool to room temp, repeat, weigh back.

The problem with this is, that SOP hasn’t been updated in 10 years and the product immediately and RAPIDLY expands and chars as the acid boils leaving a giant burnt marshmallowesque monstrosity that permanently discolors a crucible as is a huge pain in the dick to clean up. Which is what happened to 3 crucibles today. It SHOULD say, no acid on first heat, acid on second heat.

Also our ‘chemical sink’ sprung a leak and has been draining various concentrations and states of digested sulphuric acid onto the floor.

ALSO also, a production employee seized the everloving gently caress out of an FTIR by running an incredibly viscous sample on the highest flow rate and when the sample didn’t test, kept bypassing the clean and purge to pull again. So now production comes to our ftir to test and everyone watches them run samples.

Also also also apparently someone forgot the step of “slowly boil off ether in fume hood” before placing 16 flasks with like 80mls of ether into an oven and ethering the hell out of the lab.

This poo poo loving owns so hard.

Also all of this rules. I love hearing fun lab stories.

Lyon
Apr 17, 2003

Shrieking Muppet posted:

So apparently my new boss has been able to justify a sample management system, not a full LIMS like what we should be buying but its a step in the right direction. Is the goon who sells LIMS still around and do you sell a sample management system?

I'm here, always, lurking, waiting, hoping to feed on the souls of other forums members. Shoot me a PM and I can help provide you as much information as I can. We tend to be tied with the other top tier vendors for "most expensive" LIMS so we might be the wrong fit but I can probably point you in the right direction.

Lyon
Apr 17, 2003

Sundae posted:

Nothing stops that except firing you when they finally catch it out of their retain sample retests they'll do under the deviation investigation. Well, that and system linkage to auto-record data from instruments to LIMS, but ahahahahahaha spending money on computer systems validation ahahahahaha.

So yeah, unless poo poo hits the fan, nobody catches you. :(

Aren't you cGMP? Or did you move over into the R&D side in Cali?

Lyon
Apr 17, 2003
Reminder that when you're all in positions of authority, due to the SA Forums Treaty of 2012, you are beholden to buy a LIMS from me.

Lyon
Apr 17, 2003
What is GDP? I'm unfamiliar with that term. Seen plenty of GMP, GLP, GAMP, but never GDP.

Lyon
Apr 17, 2003

Sundae posted:

"Good Documentation Practices"

It's all the rules about proper signatures / witnessing, obscuring entries, comments, etc.

RadioPassive posted:

We’re not manufacturing so GMP isn’t quite right. We’re quality control so we’re all about documentation and data integrity, so GDP instead.

Oh interesting. I have never come across a GDP lab in my several years of selling LIMS. Who is the regulatory body for GDP? Is it still the FDA? What are you testing an what type of testing are you performing that requires GDP? I am trying to search for a write up of GDP laboratories but I am mostly getting information about documentation within a GMP lab.

Mustached Demon posted:

Can that lims goon pm me? I have a question!

PMed.

Lyon
Apr 17, 2003
Do you think you could interface instruments to LIMS? Basically get them connected to the network/trouble shoot any issues with software/hardware/network, determine what data needs to be transferred from the instrument to LIMS, and then map to/setup the LIMS master data.

Or would you have interest in being a business analyst? It's mostly documentation, meetings, and demoing LIMS builds to customers.

Lyon
Apr 17, 2003
Any of y’all at pittcon this year? I’ll be in the informatics section hawking LIMS if you’re bored.

Lyon
Apr 17, 2003
We are always hiring LIMS business analysts and project managers. If anyone is interested I can submit resumes. Most of our folks work from home except for when they are traveling.

Lyon
Apr 17, 2003

Cardiac posted:

Also, since there are ELN sellers here, anyone got a recommendation for a good one that is customisable to cover anything from cell expressions to protein crystallization and NMR.
Preferably self-hosted on our network and must be Mac-friendly.

IDBS seems to be the golden standard for ELN and the other big name I can think of is BIOVIA (they bought Accelrys). I don’t have any first hand experience with either product but all of my customers love IDBS so I’d start there with the understanding that they will probably be on the upper end price wise.

I sell LIMS, so a slightly different product, but as the markets/products converge we are seeing and competing with ELN vendors more often.

Lyon
Apr 17, 2003

Johnny Truant posted:

I've been migrating our old, incredibly lovely FileMaker Pro database/biorepository into FreezerWorks, and let me tell you it's impressive to see the amount of absolutely hosed data my predecessors thought was acceptable.

So many "Y" entries in numeric fields that I kind of just want to.. die.

Call me when you're ready to replace FreezerWorks :).

Lyon
Apr 17, 2003
$80k for a lab manager position seems...

Lyon
Apr 17, 2003

Spikes32 posted:

I just got approved for an internal transfer from pharmaceutical qc/micro to a LIMS/MODA Business analyst position (exciting!). But I got it based on my qc / gmp / change control experience not coding experience. Does anyone have suggestions for what I can start working on that'll benefit me for this new role on the programming side of things?

Which LIMS?

What are your responsibilities going to be? Will it primarily be gathering requirements from the business, documenting, and passing the work on to the developers or will you be making changes to the LIMS directly and serving as a system administrator?

Lyon fucked around with this message at 09:51 on Dec 22, 2019

Lyon
Apr 17, 2003

Sundae posted:

I get a real kick out of you selling LIMS products to this thread for like ten straight years. :v:

I hosed up the one real good opportunity I found here in the thread unfortunately. I’ve actually switched roles to a technical sales/sales “engineer” position so I’m not direct sales anymore but still always on the lookout for opportunities. I work for LabVantage and our product is hands down the best in the market of the major industry agnostic LIMS (us, LabWare, StarLIMS, Thermo).

We are continually enhancing our LIMS, ELN/LES, and we are adding SDMS to our core offering. Our current major competitors won’t exist in 20 years (or they’ll just be collecting legacy support revenue) unless they make some major changes. It will be us and IDBS fighting for the market depending on if the customer is thinking from the LIMS or ELN perspective.

Spikes32 posted:

I believe it's labware lims though I could be wrong about that. I haven't actually started in the role yet. I'll be making changes to the system directly and serving as system admin. I'll be serving as system admin for labware, moda and openlab CDS /Chem station. We worked with lims devs for the initial rollout to build it out for us, but that was three years ago now we mostly make changes and new methods ourselves.

Oh boy have fun! LabWare uses a programming language they developed called LIMS Basic which is based on Basic (surprise) so you might want to start brushing up on Basic basics. You’ll also want to start learning SQL. There are some differences depending on if you’re using Oracle or SQL Server but the major principles are all the same.

Lyon
Apr 17, 2003
I know some LabWare folks so if you have more specific questions let me know. I can probably get you answers.

Lyon
Apr 17, 2003

Spikes32 posted:

I don't have pms but have a few more questions I'd like to ask, do you have an email I can send your way?

Sure, ecksile @ gmail will work.

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Lyon
Apr 17, 2003
LIMS you say??

Who was the guy at AMRI? Looks like you’re most likely purchasing our software globally. It won’t be live for years probably but progress!

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