Welcome to our Experts Panel!
Want to learn from the best professionals in your field? Read our Expert Panel page and gain access to valuable insights, tips, and discussions from top experts. Whether you're looking for inspiration, knowledge, or new connections, you'll find it all here. Dive deeper into relevant topics and stay up-to-date with the latest trends!
"Top 10 requirements to consider when designing your temperature monitoring system"
When designing a temperature monitoring system for pharmaceutical cold chain compliance with FDA requirements, consider the following top 10 requirements
"How to choose between ISO9001 & ISO17025 calibration?"
Choosing between ISO9001 and ISO/IEC17025 for the calibration of a temperature monitoring system depends on various factors, including the purpose of the calibration, regulatory requirements, and the level of accuracy and traceability needed. Here’s a breakdown to help you make the decision
"BMS vs EMS"
Although a combined BMS/EMS system initially looks to be the most advantageous option, we have identified 5 factors that demonstrate that going 2 in 1 is not necessarily more advantageous.
"The hidden costs of sticking with an old temperature monitoring system—Time for a change!"
In the pharmaceutical industry, temperature control is critical. Ensuring the right temperature during the storage and transport of medications is not just a matter of quality; it’s a matter of safety. However, many companies still rely on outdated temperature monitoring systems. Here are several reasons why your system is no longer adequate today.
"5 Steps in getting ISO15189 certification"
ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. It ensures that laboratories provide accurate and reliable test results, which are critical for patient care. One of the key areas covered by this standard is temperature monitoring, which is vital for maintaining the integrity of medical samples and reagents
"From complex to easy:
FDA 21 CFR Part 11 in temperature monitoring"
21 CFR Part 11 is a regulation set by the U.S. Food and Drug Administration (FDA) that establishes criteria for the use of electronic records and electronic signatures (ERES) in the pharmaceutical, biotechnology, and other industries regulated by FDA. This part of the Code of Federal Regulations ensures that electronic records and signatures have the same level of trustworthiness and reliability as traditional paper records and handwritten signatures.
"How to deal with data loss in a temperature monitoring system"
Dealing with data loss in a temperature monitoring system, particularly in the pharmaceutical industry where data integrity is critical, involves a multi-pronged approach. Here are several strategies to mitigate risks and address data loss effectively
"Causes that can influence a wireless signal"
Wireless signals are essential for communication in today’s connected world, but various factors can significantly influence their strength and quality. Here are some of the main causes that can affect wireless signals
"Guide: Integrating your temperature monitoring system with Your LIMS"
Connecting a temperature monitoring system to a Laboratory Information Management System (LIMS) can enhance data integrity and streamline operations. Here’s a step-by-step guide to help you integrate these systems
"What if you could choose between different communication technologies in the same monitoring system?"
When choosing between wireless temperature data loggers and those that use LAN/PoE connections, several key differences and considerations arise
"Challenges in Pressure Monitoring and Control in Cleanrooms"
Measuring differential pressure in cleanrooms can be done in two ways: on the one hand, by directly measuring the actual differential pressure between two spaces; on the other hand, by calculating the differential pressure based on atmospheric pressure gauges between different spaces. Why is direct measurement better than a calculated value?
"Temperature mapping requirements"
Data oggers used for temperature measurements and mapping must meet several requirements to provide accurate and reliable data. Here are the key aspects that data loggers must meet for temperature mapping
"What you need to know about
FDA 21CFR PArt 11"
FDA 21 CFR Part 11 is a regulation that establishes the United States Food and Drug Administration's (FDA) requirements for the use of electronic records and electronic signatures in regulated industries. Specifically, Part 11 applies to companies in sectors such as pharmaceuticals, biotechnology, medical devices, and other FDA-regulated industries where electronic records are used for compliance purposes
"Are You in Compliance with the Upcoming PIC/S Standards?"
Starting from January 1, 2026, the new PIC/S standard will come into effect for hospital pharmacists in Belgium. This standard imposes strict requirements on quality management and the production of medicines in hospital pharmacies, with a focus on compliance with Good Manufacturing Practice (GMP). Hospital pharmacists must ensure proper infrastructure, documentation, process control, and staff training. An important aspect of the standard is the monitoring of critical environmental parameters, such as temperature, humidity, and air quality in production and storage areas. These parameters must be continuously monitored to ensure that medicines are safe and effective. In the event of deviations from established limits, corrective actions must be taken promptly. This ensures the quality and safety of medicines and ensures that the hospital pharmacy meets international standards.