Blood Banks and Plasma Centers are mandated to dispense blood and
plasma products that are safe, pure and potent under the stringent
guidelines issued and audited by the FDA (North America) and MHRA (UK).
These are no longer merely guidelines - they are now a legal
requirement.
To meet such strict needs, an integrated procedure of temperature monitoring and detailed record-keeping is the foundation of the compliance strategy for a Blood bank Tissue Bank or Plasma Center.
Recording the temperature inside the facility with the level of detail mandated by the regulator is time-consuming and a poor use of highly skilled staff. But non-compliance is not an option.
But the risks are high - there is now so much reliance on safe storage and traceability, that just a simple mistake such as a fridge door accidentally being left ajar has the potential to really damage vital and valuable blood products that render them useless.
For this very reason, it is crucial to implement meticulous refrigerator temperature monitoring processes. Using an automated web-based wireless medical monitoring systems, will deliver unparalleled accuracy, regulatory compliance and totally rock-solid audit trails that give both total confidence in the event of an audit from the regulator as well as protecting valuable assets.
With an integrated web-based wireless system in place, temperature values are being transmitted constantly from wireless temperature sensors to a secure server and any deviation against pre-agreed parameters will be detected and reported directly enabling you to take immediate remedial action.
Make sure that the system you choose is fully validated and all electronic records are fully FDA 21 CFR part 11 compliant and securely stored in two different geographical locations for up to 30 years.
Your temperature monitoring systems need to meet fully the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to operator names that are fully traceable.
With a properly validated system, all sensors and transducers are fully NIST/UKAS traceable and calibrated as part of the installation process. All compliance audit and validation documentation is published in electronic format on the customer's private website library. All secure website user activity is logged for subsequent qualification and audit purposes.
The integrated wireless temperature monitoring system has so much to offer a clinical facility with refrigerated assets to protect. Firstly, it will provide and far greater degree of protection for valuable blood products - not only from a financial point of view but also to ensure maximum availability. Secondly, the department will be a able to redeploy valuable and often highly qualified staff to perform more productive functions. To maintain compliance manually in a large facility can be a couple of hours per day.
And using with a web-based system, data and records are securely accessible 24/7 anywhere in the world on any device able to support a web-browser. This means that you can enjoy not only unbeatable data access at your fingertips through a web-based GUI, you can rest assured that complete compliance through rigorous data security, traceability and audit trails is guaranteed as standard.
To meet such strict needs, an integrated procedure of temperature monitoring and detailed record-keeping is the foundation of the compliance strategy for a Blood bank Tissue Bank or Plasma Center.
Recording the temperature inside the facility with the level of detail mandated by the regulator is time-consuming and a poor use of highly skilled staff. But non-compliance is not an option.
But the risks are high - there is now so much reliance on safe storage and traceability, that just a simple mistake such as a fridge door accidentally being left ajar has the potential to really damage vital and valuable blood products that render them useless.
For this very reason, it is crucial to implement meticulous refrigerator temperature monitoring processes. Using an automated web-based wireless medical monitoring systems, will deliver unparalleled accuracy, regulatory compliance and totally rock-solid audit trails that give both total confidence in the event of an audit from the regulator as well as protecting valuable assets.
With an integrated web-based wireless system in place, temperature values are being transmitted constantly from wireless temperature sensors to a secure server and any deviation against pre-agreed parameters will be detected and reported directly enabling you to take immediate remedial action.
Make sure that the system you choose is fully validated and all electronic records are fully FDA 21 CFR part 11 compliant and securely stored in two different geographical locations for up to 30 years.
Your temperature monitoring systems need to meet fully the exacting requirements of the FDA code which includes the use of unique electronic signatures specifically linked to operator names that are fully traceable.
With a properly validated system, all sensors and transducers are fully NIST/UKAS traceable and calibrated as part of the installation process. All compliance audit and validation documentation is published in electronic format on the customer's private website library. All secure website user activity is logged for subsequent qualification and audit purposes.
The integrated wireless temperature monitoring system has so much to offer a clinical facility with refrigerated assets to protect. Firstly, it will provide and far greater degree of protection for valuable blood products - not only from a financial point of view but also to ensure maximum availability. Secondly, the department will be a able to redeploy valuable and often highly qualified staff to perform more productive functions. To maintain compliance manually in a large facility can be a couple of hours per day.
And using with a web-based system, data and records are securely accessible 24/7 anywhere in the world on any device able to support a web-browser. This means that you can enjoy not only unbeatable data access at your fingertips through a web-based GUI, you can rest assured that complete compliance through rigorous data security, traceability and audit trails is guaranteed as standard.
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