Many laboratories introduce LIMS to help with sample data management and reporting. Some labs will have used the same system for 12 years without upgrades, and other labs will
The purpose of quality is to ensure standards are maintained so that products, services and processes are effective and fit for purpose. Laboratories must maintain high quality standards to provide confidence in
Validating LIMS is a fundamental requirement for GMP compliance. Where LIMS is used to store and process GMP data, it is imperative that
The Medicines and Healthcare products Regulatory Agency (MHRA) has a responsibility to protect public health by ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. Each year, they conduct
Operating a laboratory within regulatory requirements can be a challenge. The wording of regulations is typically cryptic, and there’s always room for different interpretations. Audit trails are an important factor for compliance because
In this article we discuss four of the most common misconceptions about data security.
#1 "Desktop is more secure than web applications."
Desktop programs run locally on a PC whereas web applications run in a web browser via the internet. Most people believe data stored through a desktop program is more secure than browser based applications because the perceived control over data. Not all desktop programs store data within the local network. Some desktop programs access, send and store data on remote servers which is the same data storage method as web applications.
FOR IMMEDIATE RELEASE:
FDA 21 CFR Part 11. What can we learn from the US Secretary of State’s alleged 33,000 deleted emails?
By now we have all heard in the news about the alleged deleting of 33,000 e-mails by one of the candidates for the presidency of the USA. The suggestion is that, Hillary Clinton, the United States Secretary of State at that time, had exclusively used her private email server for official communications, rather than official State Department email accounts maintained on federal servers. Those official communications included thousands of emails that would later be marked classified by the State Department retroactively.