Biotech companies face unique challenges when it comes to product development and production. They must adhere to strict safety regulations, stay on top of rapidly changing technologies, and find ways to reduce costs without compromising quality or putting customers...
It is well known that Quality Management Systems (QMS) are essential for any industry, but what are they and how can they be applied to the life sciences sector? For businesses working in the life sciences and pharmaceutical sectors, a QMS is essential for the entire...
Medical device companies often have to adhere to strict standards in order to operate. These standards help ensure safety and quality control for both the company and its customers. One of the most important tools used by medical device companies is a Quality...
Audit trails are a critical requirement in clinical trial management systems. These computer-generated records capture all the activity in the system and are valuable tools to maintain a high level of data integrity and are extremely useful to study teams and...
The pharmaceutical industry has undergone significant changes over the last decade. A greater emphasis is put on cost control, while public health concerns call for increased efficiency. This transformation has led to new challenges for quality management systems...
Discover the usefulness or pharmaceutical quality management systems and the benefits they offer life sciences companies.
Discover the importance of remote monitoring in clinical trials and the best remote monitoring practices.
Discover the importance of investigator site files (ISF) in clinical research and the best methods to keep an organized ISF.
Trial master files are essential for the completion of clinical studies. However, the management of TMF content can be very complex. eTMF systems represent the next step in clinical trial document management and promise to become an integral part of all future...
Many important processes in the pharmaceutical industry produce a large number of documents. From doctors’ prescriptions to documentation on clinical trials, the amount of information that must be kept on record is staggering. Document-related processes exist on...