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Preparing for clinical trial approval, using the Direct-to-Patient supply model, monitoring recommendations, and more. Here is how clinical trials are run today.

Direct-to-Patient: The Trend in Clinical Trials

Direct-to-Patient (DtP) is the trending clinical supply technique with a promising future, revolutionizing the pharma world. DtP is based on an integr....

Kit Level Monitoring: Eliminating Data Collection Headaches

With the ever-increasing need for more accurate data logs in modern clinical trials, the old-school method of manually updated data logs faces many ch....

Data Collection for Clinical Trials

Choosing the right data logger or indicator plays a vital role in the success of any clinical study. Contract research organizations (CRO) have a lot ....

Why Real-Time Monitoring is Saving Clinical Trials

Real-time monitoring in clinical trials is gaining ground because monitors do not have to visit the sites to transfer or review data. Data is captured....

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Cold chain monitoring can be a difficult process. We can guide you from start to finish.

Stability Budget Explained

Most biopharmaceutical products are subject to change as they age. Nevertheless, they remain stable as long as they retain their properties or potency....

Making the Right Cold Chain Logistics and Packaging Choices for Your Products

Your unique products need to be transported in an appropriate container for the transportation method. Which container and which transportation method....

Get Everything Under Control with the Right Software

Let's be honest. Cold chain management is difficult. Moving refrigerated and frozen goods from Point A to Point X, Y, and Z—especially when using a th....

GDP for Cold Chain Compliance

Pharmaceutical transportation faces many challenges, including possible product degradation due to exposure to unfavorable conditions. The good distri....

Automated Control Systems in a Cold Supply Chain

Today, automated control systems are everywhere you look in manufacturing, storage, and delivery supply chains. Smart location, logistics, condition p....

Real-Time Monitoring Technology

Real-time technology has not been around for long, but in the short time of its existence, there have been major changes and improvements. As the mark....

Calibration Certificates for GDP - Compliant Data Loggers

What are the benefits of using a GDP compliant temperature data logger? When it comes to the ISO 17025 accreditation, it is a must-have for laboratori....

Introduction to Cold Chain Monitoring

The growth of cold storage facilities, temperature controlled shipments, freezers, and refrigerators in the second half of the 20th century have nurtu....

Temperature Monitoring for Each Supply Chain Step

In each supply chain step, there are unique challenges to consider. Look at these issues, and prevent problems before they arise.     Active Pharmaceu....

Real-Time Cold Chain Monitoring

There is a lot that can go wrong during transportation given the unforgiving conditions goods and supplies sometimes face. Statistics estimate around ....

Documenting Temperature Excursions

It is the responsibility of every pharmaceutical manufacturer to guarantee every medicine they deliver to a patient is of the highest quality. Maintai....

Mean Kinetic Temperature (MKT) Explained

Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy a....

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When it comes to cryogenic shipping and storage, there are many criterias one has to consider to comply with all the requirements. In this article we cover all you need to know about the availability, usage and compliance of cryogenic shipping and storage

Fleet Qualifications for Cryogenic Containers

As bio-pharmaceutical manufacturers are aware, the industry is facing a unique combination of circumstances. Not least, in the wake of the Coronavirus....

Ultra Low Temperature Data Logger for Cryogenic Applications

In this article, we shall take a look at cryogenics as a whole and expound on what it all means. We’ll explore the different cryogenic applications ou....

How to Ship Products Using Cryogenic Containers

Cryogenic containers, also known as liquid cylinders, dry-shippers, LN2 shippers, or cryo-cans, are vacuum vessels with multilayer insulation in the a....

Why is Monitoring a Cryogenic Container Difficult?

Cryogenic containers, often known as dry-shippers, are one of modern medicines’ most groundbreaking innovations. Because they use liquid nitrogen (LN2....

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Temperature-controlled logistics and monitoring of direct-to-patient distribution and DCTs can be easily managed with LIBERO data loggers and indicators.

End-to-End Kit & Box Level Monitoring

For decades, the collection, storage, and transport of human biological specimens has formed an integral part of pharmacological trials, medical treat....

Box Level Temperature Monitoring—Do I Need it?

In the pharmaceutical industry, specimens and costly drug products are typically sensitive to temperature changes during shipment and storage. Box lev....

Monitor Temperature Deviations

The pharmaceutical industry accounts for about 60% of the global market, and it continues to grow by the day. Many of these products are time and temp....

Shipping Pharmaceuticals

If your company transports or dispatches pharmaceutical products, medical tests, or biological samples, you will likely be well aware that these shipm....

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GxP Compliance is a very important topic when it comes to Monitoring Solutions used within the Pharmaceutical Industry. It might seem complex and complicated in the beginning - let us help you answer any questions you may have on GxP Compliance.

Temperature Sensor Calibration: All You Need to Know

In this section, discover why the calibration of temperature sensors is necessary within the pharmaceutical industry. You will also find some valuable....

GxP Regulations for Germany and Switzerland

Individual market participants who handle medicinal products and medical devices commercially face the question of which relevant standards, laws, reg....

All You Need to Know About Validation, Qualification, and Mapping

There are many regulations for good business practices (GxP), and even when the guidance is contradicting, all sources agree on one topic. If you work....

Lessons of GMP Failures: Why it’s Everyone’s Business Part 1 of 3

Nowadays, everyone is attempting to save, reduce, and cut back – except when regulatory requirements are involved. Such requirements are becoming more....

Documentation and Computerized Systems Regulations

Transport companies and couriers that carry pharmaceutical product consignments have to adhere to guidelines. In particular, product releases must tak....

Pharma GxP for Beginners

GxP is an abbreviation for good "x" practice. The "x" denotes various disciplines, including disciplines within the pharmaceutical industry.   GxP is ....

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Lab monitoring is part of GLP standards that should be applied in any laboratory setting regardless of the type of labor and the facility's size.

Equipment Control: 5 Steps to Real-Time Monitoring in Labs

Equipment control is a proactive step in lab monitoring to help prevent malfunction, reduce downtime, improve efficiency, and ensure product safety. O....

Quality Control in Laboratories

Quality control is a critical element in laboratory monitoring that helps ensure product integrity and process accuracy. Without quality control proce....

Equipment Qualification & Equipment Mapping in Labs Explained

Analytical instruments provide scientifically proven data on products and samples and make sure they meet the specified standards. The instruments var....

Lab Guide to Installation, Qualification, and Calibration of Monitoring Systems

Lab equipment management is vital for the proper functioning of the lab and the safety of end-users. Critical elements in lab machine management are i....

The Ultimate Guide to GLP Compliant Temperature Monitoring

Good laboratory practice (GLP) outlines standards to guide temperature monitoring in the laboratory. GLP compliance is critical because temperature co....

Security in the Cloud: ISO 27001 Explained

With more and more organizations moving their systems to the cloud, security in this environment is increasingly becoming a pressing concern. Security....

Cloud vs. On-Premises: Cost Comparison for Laboratory Monitoring System

While modern laboratories are often equipped with valuable equipment and irreplaceable specimens, integrating proper risk management procedures are am....

Lab Data Management: Cloud vs. On-Premises Data Storage Compared

Lab data management is crucial to GxP requirements. Pharmaceutical lab data has come under a variety of cyber-based attacks in recent years. As such, ....

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Obtain an overview on how pharmaceutical products like vaccines and medicines can be stored and transported correctly, while taking temperature changes into consideration.

Sensor Network: What is the best radio connection for pharmaceutical rooms?

Setting up the ideal pharmaceutical temperature monitoring system has everything to do with the radio connection through the wireless sensor network. ....

Best Practice for a Refrigerator Temperature Log in a Pharmaceutical Environment

Effective monitoring of refrigeration temperatures is a vital requirement for pharmacies, medical centers, and pharmaceutical laboratories. Maintainin....

GMP Pharmacy Guide for Temperature Monitoring

There are various methods to comply with GMP standards in the pharmaceutical environment. Read on to learn more about compliant ways of temperature mo....

Pharmaceutical Quality Control: 24/7 Real-Time Refrigerator Monitoring in 5 Steps

Real-time monitoring is a critical element of pharmaceutical quality control. A real-time system can generate data trends that confirm product quality....

Pharmacopeia Europe and Helvetica: This is the Status Quo

The primary purpose of this quality standard on therapeutic products is to make sure that all the products that go into the market are effective, safe....

IoT Logger vs Data Logger Cloud: Cost Comparison for Pharmacy Monitoring

When it comes to efficient pharmaceutical temperature monitoring, an IoT logger and data logger cloud are the two primary devices used in monitoring a....

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Having a compliant Cleanroom Environmental Monitoring might sound very complex. But it doesn't have to be. With the right tools and the right partners at hand, it is pretty straight forward.

Cleanroom Environmental Monitoring Regulations

In industrial manufacturing environments such as those within the pharmaceutical sector, monitoring cleanroom environmental conditions is essential. C....

Software Requirements for Cleanroom Environmental Conditions Monitoring

Software used in pharmaceutical risk management has several components that ensure safety and viability. Each component has a specific job inside. To ....

Cleanroom URS

Cleanrooms are perhaps the most critical zones you’ll find within a medical or pharmaceutical facility. For cleanrooms to operate optimally, they need....

Cleanroom Qualifications

The current pharmaceutical boom has pushed many companies to expand their production by opening remote facilities. However, the biggest challenge for ....

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Temperature monitoring can ensure food and medication is safe for consumption.

Reporting: What is an audit trail?

What is in the report?   Regulations require strict system security. Carefully selected users must have unique usernames and passwords to work the mon....

The Pharmaceutical Temperature Monitoring Process

Building management systems monitor and control power systems, fire systems, security systems, air systems, etc. The air system captures the temperatu....

Temperature Monitoring Regulations for Pharmaceuticals

National and international organizations regularly share findings and best practices in order to provide the public with safe drugs. GxP, or good (“x”....

Change in Temperature—The Result

A product sold to be inhaled, ingested, injected, emitted, or absorbed has great potential to either improve or disturb the working-condition of the e....

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Ensuring warehouses operate optimally does not need to be a daunting task when the appropriate systems and procedures are in place. Obtain a Warehouse Temperature Monitoring Guide for best practice solutions.

Real-Time Monitoring in a Warehouse Control System

The world has never been so interconnected, and it has never been so essential for supply chains to be closely monitored at each stage, especially for....

Best Practice for Sensor Calibration

What is temperature calibration? Temperature calibration is dependable, and documented comparison of an instrument against another device that is alre....

Warehouse Monitoring: Cloud vs. On-Premises Data Storage

For efficient warehouse monitoring, you need a robust, fast, and secure data storage infrastructure. Cloud storage offers flexibility to scale up or d....

GMP Warehouse Guide for Compliant Temperature Monitoring

Good Manufacturing Practices (GMP) is a system implemented by most countries to ensure that products are consistently manufactured and controlled acco....

The Climate Controlled Warehouse

Pharmaceuticals need warehouse storage facilities with both temperature and humidity control. Climate controlled warehouses offer the best storage spa....

ISO 9001 vs. ISO 17025 Calibration Requirements

Following the 2017 update of ISO 17025, many were left confused about the standard's purpose and how it relates to the Quality Management System (QMS)....

Warehouse Temperature Monitoring System: Installation, Qualification & Calibration in Detail

In the pharmaceutical industry numerous and stringent regulations exist to ensure the efficacy of medications throughout the entire supply chain. A si....

Warehouse Mapping Done Right: Qualification & Mapping of Storage Rooms

Warehouse mapping is essential for any business that operates with its own storage and logistics requirements. Indeed, storage mapping is one of the k....

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Vaccine logistics to developing countries is a huge challenge. The following article is all about WHO involvement in assuring transport as well as monitoring standards of shipping vaccines.

WHO PQS Process

WHO Performance, Quality and Safety (PQS) process prequalifies products, equipment and devices so that UN agencies and member states are assured of th....

Vaccine Vials Transport and Its Challenges

In the world of medicine, the lives of patients can literally depend upon the safe and effective administration of vaccines. The handling, transport, ....

COVID-19 Vaccination: How to Ensure Temperature Monitoring During the Complete Supply Chain

Vaccines must be maintained at required temperatures to maintain their safety and effectiveness. Manufacturers that develop COVID-19 vaccines and prov....

WHO Vaccines and the History of Vaccines for Children

Vaccines help to keep our children healthy and they play an important role in their quality of life. The practice of immunization dates back centuries....

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