A Quick Guide to 21 CFR Part 11 compliance
As with most digital management regulations, 21 CFR (Code of Federal Regulations) issued by United States Food and Drug Administration (FDA) can seem complicated if the regulatory organizations are not
As with most digital management regulations, 21 CFR (Code of Federal Regulations) issued by United States Food and Drug Administration (FDA) can seem complicated if the regulatory organizations are not
An electronic lab notebook (ELN) is a computer system designed to replace paper laboratory notebooks. Lab notebooks are generally used by engineers, scientists and technicians to document research, experiment and
LIMS: Everything You Need to Know About LIMS Implementation There is no shortage of laboratories that are currently enjoying the unique advantages of a laboratory information management system (LIMS). Equally many are
Using a LIMS for your laboratory Selecting a Laboratory Information Management System (LIMS) for any lab is usually not a simple decision. There are different types of stakeholders i.e. users
Although some labs may opt to record their experiments on paper, or have personnel keep track of ordering information manually, these methods are outdated and have several limitations. The practice
In today’s dynamic world of scientific research and laboratory processes, staying ahead of the curve is crucial. As technology continues to advance, so does the need for efficient & effective
Overview of LIMS and its selection process In today’s global scientific community, laboratories worldwide are recognizing the importance and necessity of implementing a Laboratory Information Management System (LIMS). The implementation of
Although laboratory information management software (LIMS) automatically brings plenty of unique benefits to laboratories, like any technology, they become obsolete over time. Inevitably, a better version of it will be made available
Digital transformation is a process that aims to improve an organization by implementing and practicing significant changes to its processes through combinations of information, computing, communication, and connecting technologies. Digital
Compliance with US FDA’s 21 CFR Part 11 Regulations is very critical for medical device and pharmaceutical companies. However, there are some grey areas that companies often face when they