Let’s ask the questions; Does it need to be validated? What is involved in the process of selecting and installing a new temperature monitoring program? Does it need to be a full blown system, can I short cut the process? Can I install it or should I have the company do the work? Do I need a backup plan?
Yes the program should be validated, as it protects your samples which are your validation of your process. If you lose your samples, you lose the ability to sell you product. As with any validated piece of equipment you need a User Requirement’s Specification (URS) A Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and a Performance Qualification PQ). If you’re spending the monies for a program, why would you only pay for part of a system? Your investment in this system is a long term purchase and should be looked at it carefully to ensure you are getting the correct product for you application. You don’t have to have all the bells and whistles, but look at the options and see if you can see process improvement to our program. Yes you can install parts of the program and should be discussing that process with the vendor. Remember, part of the purchase price is for installation of those parts of the program, incorrect installation on your part will affect the validation and may void any warranty. The IQ process will look at this operation. The last issue is the backup plan. What do you do if your system fails? I will discuss this later in the article.
Let’s discuss the URS (https://best-storageprocess.com/blog/user-requirements-specification-urs/). This where you define you’re requirements for the program being purchased, that your validation process with confirm. This is where looking at multiple systems prior to starting the process allows you to define your requirements. Not all programs provide the same processes and buying a program because it is the cheapest, may cost you money in the long run due to work arounds for the missing functions. At a minimum the program should be wired or wireless for communication, validated, Part 11 compliant, contains a calling list, archive your monitoring data and have the ability to be expanded in the future. Sounds simple, but you still need to discuss additional points such as being able to adjust the alarm limits for each sensing point, have a time delay on alarm activation to avoid business related outages, multi stage temperature alarm activation, ability to disable probes. In your chamber validation, you performed a door open test that shows the effect on the chamber and using that data to determine and justify parameters for the use of time delayed point activation. In this validation data you can justify the number of probes used in the monitoring of a chamber. One of the early questions was “Can I short cut the system?”. Your validation data allows you to “optimize” the program, so short cutting is not an option. My opinion is that a monitoring program should look at the HI/Low/Control points (3 points) of the chamber. This monitoring looks at the full range of temperatures seen in a chamber during the daily operation. It allows for the answering of impact related questions to outages. This placement allows for constent monitioring of the chamber operation and can identify operational issues that may affect the validation of the chamber. Could the program improve your security process for access to sample? Does it have a key card door option? With this option you could track access to your samples and be notified when someone opened a door causing an outage. This may explain “ghost” outages which may have no visible reason and cause you to think the unit is not operating correctly. You may need to add this type requirement to update your security program. The validation of reports being used in decision-making needs to be identified in this process. Since these reports support “why” a decision was made and answer questions on outages or system performance, a plan for storage of these reports needs to be looked at. Remember these reports are your support data and may be asked for by the agency during inspections. Reports should be definable by the user to allow for retrieval of data within specific ranges. If you think about going paperless, a process needs to be discussed in the URS.
Can you run a wireless program or do you need a hardwired program in your facility? This is an important detail that needs to be discussed up front with any program being looked at. The construction of a facility may cause the failure of wireless, or the RF interference from equipment may cause issues. A wireless system is exponentially cheaper than a wired system and may be attractive in early discussions. Any company selling a wireless system should be willing to test their system in your facility. If your building a new facility and designing a new program make sure your wireless testing is done with product or simulated product in a chamber to present transmission interference. The addition of product into a chamber may block signals which tested OK when the chamber was empty.
When looking at the calling list option, detail needs to a focus point. How many people can be on the list? Is the list programmable to allow for working hours and non-working hours? Can it be modified to allow for vacations? Is the program security protected? Does the function track the calling process until acknowledged? Can it line test to ensure that communication is not interrupted when in standby mode? Nothing worse than coming in on a Monday and having a chamber in alarm and not having the system notify you of the outage because the line was taken out of service. Remember this process needs to be validated and the lack of notification is a failure of that validation process. Tracking of calling allows management to follow the process and identify issues in the recipient process. Are the people on the list really the ones who need to be notified and respond to the issue? Can the calling option tell you what and where the excursion is and what the current condition is? Can the person answering the call stop the calling process? This option prevents multiple people from showing up for an excursion when one person can handle the process.
Multi limit or delayed alarm points allow the chamber to equilibrate after a door opening before alarming. In a two tier system the alert limit is set ±2⁰C of set point and allows for a 15 minute duration outside of this limit (Validation door open data) after the 15 minute time period has been met the alarm sound and requires documentation of the outage. For the 2 tiered systems I have seen at least one program where an alarm can be generated if a temperature or RH ramps up at a faster pace than normal. I.E specified range is ±4⁰C of set point, the temperature ramps up 4⁰ in a 5 minute period the system alarms immediately, thus identifying the issue early in the excursion. If a chamber has an auto shutdown limit this option ensure that function is working as validated as it notifies as the unit reaches that shut down point. Being able to disable a probe that keeps causing issues needs to an option to silence the issue.
Most programs can run automated reports of the past performance in a daily, weekly, monthly accumulation of data. These reports should be validated and run after the day change to allow all functions to archive data before running the report. There should be a process incorporated in the reviewing of auto generated report that documents the reviewer’s attention. Because an alarm was not generated, does not mean that the data is within specification. All reports should be reviewed to assure accuracy and compliance. Anomalies in data need to be investigated immediately. In a paperless system these reports and review need to be stored for verification of the process. Unvalidated reports or adhoc reports should not be used for decision making.
Some programs allow a person to login from a remote location and review the excursion or the condition of a chamber. In this process, make sure that your IT group is involved to allow access through the firewall. Failure to meet the needs of IT may cause this option to be useless as the system resides on IT’s network.
What happens if your system fails or becomes inoperable? For power you can attach to your UPS or backup generator. But what is your plan if the computer breaks down, do you have a process to record the data? Backup calibrated chart recorders, TempTale’s etc.. Can you recover the previously stored data?
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