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Gabor Szabo

mercury drug
Drug Storage Monitoring

Cold Chain Management Guidelines – Philippines

In the Philippines, all medical establishments and outlets applying for a license to manufacture, import, distribute or sell vaccines and other biological products have to comply with these requirements. To be able to get a License to Operate (LTO), all establishments have to be compliant and prove that they are Read more…

By Gabor Szabo, 2 years2 years ago
vaccine temperature monitoring
Drug Storage Monitoring

New Zealand Vaccine Storage Regulations

New Zealand vaccine storage regulations and guidelines. How to comply with New Zealand vaccine storage requirements. Proper storing and handling of vaccines is very important in the medical sector. Each country has specific regulations that must be adhered to, although most of the vaccine handling rules apply internationally. In this Read more…

By Gabor Szabo, 2 years2 years ago
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Drug Storage Monitoring

Canadian National Vaccine Storage and Handling Guidelines

Canadian national vaccine storage and handling guidelines. How to comply with Canadian regulations for temperature sensitive vaccine storage. Vaccine storage and efficient handling – from the time the vaccine is manufactured until it is administered – is a key component of the immunization programs. Although the specific recommendations for vaccine Read more…

By Gabor Szabo, 2 years2 years ago
open or closed digital signature system
Drug Storage Monitoring

Understanding FDA 21 CFR Part 11

Understanding FDA 21 CFR Part 11, and how it affects you. Signature of digital documents for the pharmaceutical industry. Pharmaceutical manufacturing is a strictly regulated process and requires each step to be well documented and precisely followed. The records can be paper-based or electronic. The FDA provides guidelines for manufacturers Read more…

By Gabor Szabo, 2 years2 years ago
21 CFR Part 11
Drug Storage Monitoring

How to comply with FDA 21 CFR Part 11

An organization can meet the compliance requirements of FDA 21 CFR Part 11 in multiple ways. For example: Using a non-electronic paper-based approach Using a Quality Management System software with compliant document management features Using a Document Management System designed for use across industries Using a Document Management System designed Read more…

By Gabor Szabo, 2 years2 years ago
FDA 21 CFR Part 11 Compliance
Drug Storage Monitoring

FDA Requirements 21 CFR Part 11 Explained

What does the FDA requirements 21 CFR Part 11 stand for? It is important to understand it for medical device developers, who are considering entering the US market. There are lots of requirements and regulations in this huge and complex marketplace, in this article we will provide a guide to Read more…

By Gabor Szabo, 2 years2 years ago
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Pharma-Mon by AKCP

AKCP is the worlds leader in network enabled sensors. With over 30 years experience in providing professional sensor solutions our pharma-mon line of products are tailored specifically for the needs of the pharmaceutical industry. Temperature sensors are NIST traceable, calibrated at the factory and never require re-calibration. We use advanced wireless tunnel technology for communications with up to 10 year battery life. Our central monitoring software and document management system is fully compliant with FDA CFR 21 Part 11 requirements.

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