Temperature Monitoring Systems

[Nicki]

We are looking at new temperature monitoring systems - does anyone have any good or bad experiences with any systems? We need something to cover 3 sites, 2 of which are not staffed overnight.

thanks,

Nicki

[Malcolm Needs ☆]

Many of the NHSBT Centres use Contronics.

Unfortunately, I am now at home, but will find out more and contact again tomorrow.

:)

[Malcolm Needs ☆]

This is the address of the Contronics website.

www.contronics.co.uk/

They are good, but I understand, a little pricy. I'm not sure about that, so I may be doing them a complete disservice.

[kneed33]

We use the Datatron system in all of our blood centers. It has worked well for us.

[Alternatives]

Nicki, I have posted this few months ago. I suppose it will help you for your selection. I don't remember where i found this paper but still interesting. Also, product section of BBT.

Benoît

1. Ask around: blogs like this one, co-workers, colleagues, members of association but also quality or lab manager in others pharmaceutical companies or labs and CRO who are as regulated as you. A lot of associations exist on cold chain and you could extend your network and knowledge about challenges and needs you may not thought.

2. Shop around: you know some systems and companies...there should be some others you did not know as there are multiple competitors and not only 2 sharing this market. Google it. Visit some association web site. Call industry players. Ask your wholesalers.

3. Ask a manufacturer that has both top-notch customer service and the ability to be a team player: installing a system require energy and time from both parties during a couple of weeks. Also, if you have a good knowledge of what is the cost of cold chain failures, some of your colleagues or personnal may not. Selected company will have to train and communicate with all these persons, within a specific schedule time and budget.

4. Choose a certified system: CFR Part 11 of course, PICS foir validation, AABB, JCAHO, FACT...there are a lot of regulatory! System will have to be qualified under strict protocol and not every monitoring system are enough efficient or compliant for blood and pharmaceutical products. choose a player who knows and understand your challenges, has an excellent idea of regulation (and one to come) and has experience in industry. Think regulation!

5. Easy to install but easy to configure and maintain once your staff is left to do so: Installation is one challenge, but usually, you will lead this project under budget and time. This step done, ask questions on how is the difficulty level to desactivate your account for your vacations, add some new alarm receivers, set-up a new fridge, add delays to alarms...A user friendly system saves time in your every day life.

6. Get the complete package: real time system, audit trail, warning and excursions alarms on cell, email...etc, several type of reports and charts...It is useful or it's compliant...you need it.

7. Mix wired and wireless: it's up to you for this choise. But think wireless system reduce budget for installation, facilitate your life if you want to move/change an equipment, no wires to fix through wall or equipments doors...etc. System should sometimes mix with wired sensors for thermocouple, pressure, or others specific measures (CO2, H2S, o2...etc). Memory should be present on diferent items to never lose any data (sensor/antena/hub...), and system should be installed with UPS for power failure.

8. Look beyond the basis: A system that can host an unlimited number of data points is usually the best long-term option to optimize the return on investment.Also, think to speak to your other departments as labs, oncology, pharmacy...maybe you could split budget, share experience, as they need also some monitoring system for storage. Some upgrades cost as much as a whole new system from another manufacturer. That may be a sure sign that it is time to switch manufacturers if your facility already uses an automated monitoring system.

9. Team up with an innovated company: RFID, intagrated systems for monitoring during transportation...a lot of new technologies and applications are around the corner. That does not mean you will need right now, but systems have to be adapted and upgraded on a regular basis.

10. Think of validation and training: your system will have to be qualified under protocol (IQ/OQ) and your personnal trainned. Always ask to include this in your quotations!

11. Include a support and calibration plan: you or your staff will maybe need some help. Always have a support that will not kill your budget. Always include in your contrat diferent service solution you have to solve your probles (by phone, email, VPN access, user manual, technical support...and of course hourly price if someone has to come at your facility!). Calibration could cost you some money and it has to be done yearly. Budget it and ask for some exchange programs with passed time sensors.

Good selection!

[yhbiotek]

Try this:

http://www.elpro.com/produkte/zmonitoringsystem/zmonitoringsystem_e.htm

[RR1]

We are looking at new temperature monitoring systems - does anyone have any good or bad experiences with any systems? We need something to cover 3 sites, 2 of which are not staffed overnight.

thanks,

Nicki

In the past I didn't have a good experience with a completely wireless system- it was terrible. Messages were delayed or sometimes were just not received depending on the mobile network traffic.

I am also looking to purchasing similar situation to yourself. My main criteria is that the system must relay info via the hospital intranet not wireless.

[M_Allan]

although this topic is not that new anymore, I think it is wise to give some

comments on this.

Regarding RR1's remark on delayed messages or not receiving them due to mobile traffic.

I do not think, that this problem has to do with the monitoring system itself.

If phone-lines are overloaded or off-line, there is no monitoring system in the world that

will notify you in case something is wrong.

To solve this, an audio/visual alarm could notify the staff in case something is wrong.

Next, most systems will re-dial the user, or phone the next person in the phone-list,

if not answered.

Delay on re-dial can usually be set in the software, so the system can re-dial instantly if

a person can not be reached.

Combining wireless with a hard-wired network is no problem at all.

The wireless sensors are picked up by a receiver, and send over the hard-wired network to, where-ever you want.

This also goes for the system " Nicky " needs.

When the network goes down, the data will buffer at the remote site, and the system will notify the users of the incident, and will flush the buffered data to the database, as soon as the network is back on line.

In regards to the 21 CFR and FDA compliance, I would be careful. Lots of vendors

say their system is, and I have seen enough garbage.

A lot of the software, vendors sell, are "home brewed", and their interpretation of

being compliant is often not according the book.

What we call a bug, in the software, the vendor will call " feature ", and once

purchased, you are stuck with it.

I have tested several systems, and none is perfect.

In regards to the mentioned Elpro system. Not bad at all, but a bit to expensive

if we look at the amount of loggers that need to be installed, and later validated.

Many Blood-banks have plenty of sensors, and most loggers do not hold more

4 to 8 inputs, so 80 inputs is a lot of expensive loggers.

Systems can be a lot more simple, and still according your needs.

Also, the human interface is very important.

It should be easy for a user to inhibit an alarm.

I know Blood-banks, where samples are handled by the 100s. Moving samples in and out.

For that, it should be easy to inhibit and comment an alarm.

With the current wireless technology, systems can be a lot cheaper, and still be reliable and accurate.

Before you buy, let a vendor set-up a demo system, so you can get used to

the interface, and test it in depth.

Let your QA investigate the validation protocol, and then decide.

Let them monitor a fridge at the remote site, and let your IT check the integrity of the data collection.

Have fun.

Marc

[Mabel Adams]

In regards to the 21 CFR and FDA compliance, I would be careful. Lots of vendors

say their system is, and I have seen enough garbage.

A lot of the software, vendors sell, are "home brewed", and their interpretation of

being compliant is often not according the book.

I am having trouble finding what this electronic signature requirement really means for a transfusion service in the US getting a wireless temperature monitoring system. If the vendor says they are 21 cfr compliant, what does that mean they do? If they don't claim to be compliant, is there any reason why we aren't allowed to use them as long as they have secure access and we define what our staff can do with the access? Elucidation would be much appreciated--or at least a link to something that is more understandable than the FDA verbage.

[C-dub]

My center uses the Mack-Plexxium system. We are large and have several donor sites and various temperature ranges to monitor. It seems to be working very well, but I don't have any hands-on experience with it myself.

http://www.mackinfo.com/plexxium.html

[Alternatives]

Hi Mabel, you're right and CFR PArt 11 is not a 1 page flyer! Here what you can check. It's not exhaustif but might answer to your question:

Is the system validated?

Is it possible to discern invalid or altered records?

Is the system capable of producing accurate and complete copies of electronic records on paper?

Is the system capable of producing accurate and complete copies of records in electronic form for inspection, review, and copying by the FDA?

Are the records readily retrievable throughout their retention period?

Is system access limited to authorized individuals?

Is there a secure, computer generated, time stamped audit trail that records the date and time of operator entries and actions that create, modify or delete electronic records?

Upon making a change to an electronic record, is previously recorded information still available (i.e., not

obscured by the change)?

Is an electronic record's audit trail retrievable throughout the record's retention period?

Is the audit trail available for review and copying by the FDA?

If the sequence of system steps or events is important, is this enforced by the system (e.g., as would be the case in a process control system?)

Does the system ensure that only authorized individuals can use the system, electronically sign records, access the operation, or computer system input or output device, alter a record, or perform other operations?

Is there documented training, including on the job training for system users, developers, IT support staff?

Is there a written policy that makes individuals fully accountable and responsible for actions initiated under their electronic signatures?

Is the distribution of, access to, and use of systems operation and maintenance documentation controlled?

Is there a formal change control procedure for system documentation that maintains a time sequenced audit trail for those changes made by the pharmaceutical organization?

Is data encrypted?

Are digital signatures used?

Do signed electronic records contain the following related information?

- The printed name of the signer

- The date and time of signing -

The meaning of the signing (such as approval, review, responsibility)

Is the above information shown on displayed and printed copies of the electronic record?

Are signatures linked to their respective electronic records to ensure that they cannot be cut, copied, or otherwise transferred by ordinary means for the purpose of falsification?

Are electronic signatures unique to an individual?

Are electronic signatures ever reused by, or reassigned to, anyone else?

Is the identity of an individual verified before an electronic signature is allocated?

Is the signature made up of at least two components, such as an identification code and password, or an id card and password?

When several signings are made during a continuous session, is the password executed at each signing?

If signings are not done in a continuous session, are both components of the electronic signature executed with each signing?

Would an attempt to falsify an electronic signature require the collaboration of at least two individuals?

Are controls in place to maintain the uniqueness of each combined identification code and password, such that no individual can have the same combination of identification code and password?

Are procedures in place to ensure that the validity of identification codes is periodically checked?

Do passwords periodically expire and need to be revised?

Is there a procedure for recalling identification codes and passwords if a person leaves or is transferred?

Is there a procedure for electronically disabling an identification code or password if it is potentially

compromised or lost?

Is there a procedure for detecting attempts at unauthorized use and for informing security?

Is there a procedure for reporting repeated or serious attempts at unauthorized use to management?

Is there a loss management procedure to be followed if a device is lost or stolen?

Is there a procedure for electronically disabling a device if it is lost, stolen, or potentially compromised?

Are there controls over the issuance of temporary and permanent replacements?

Benoît

Edited February 2, 2010 by Alternatives

[M_Allan]

Benoit,

That is a very impressive list.

Important is, that no vendor can claim that his or her software products are certified Part 11 compliant.

A vendor, instead, can only say that he has all of the Technical Controls for 21 CFR Part 11 compliance built in to his product.

If they work correctly....... that is another question.

I think, that it is important, as I mentioned before, to let a vendor install a demo unit, and have

your QA and IT test the system in depth.

Marc

[Alternatives]

Hi Marc.

Yes, i am totally agree with you. My point was to show firstly how many points could be debated into the CFR part 11. Also to share a kind of check list people could use.

Does the selected system will work correctly? I would say that it's the objective of the qualification to demonstrate that the system work as it is supposed to do, but, i would add that for any informatic/electronic/technical system, problems could happen. So the objective is to find a company with the higher rate of satisfaction and stability (compare companies, ask references...etc), and check how problems are fixed and what is the level of quality offer by the vendor, how do they react, how fast...etc.

And yes, it's also important to let QA or IT people test the system. It could be a demo unit or an SaaS (software as a Service; software is hosted by the vendor. Material at the customer's facility. Connection through internet). Several possibilities and agreements could be implemented.

Benoît

[Mabel Adams]

Next question: can anyone share a protocol for validating a centralized monitoring/alarm system. Testing each alarm sensor is obvious as is testing what happens when they get disconnected from the system, but beyond that, what is important not to miss without going into overkill mode?