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Computerised Systems: A Summary of 2016 MHRA Inspections

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

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Is My Audit Trail Regulatory Compliant?

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

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Don't forget this when addressing data integrity!

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Four Common Misconceptions about Data Security

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.

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Our Founder Dr. Paul Moran, Leading the way in Data Integrity

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LabHQ LIMS UKAS accredited certification to ISO 9001:2015 for Quality Management Systems

FOR IMMEDIATE RELEASE:

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FDA 21 CFR Part 11 and The US Presidential Election

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.

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Hot topics at CPhI

The CPhI conference in Barcelona did not fail to deliver on hot industry topics and trends in global pharma. After meetings with clients, new contacts and industry thought leaders the Broughton team were well placed to gather commercial and technical opinions shaping the future direction, technologies, opportunities and threats in pharma.

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It’s nearly CPhI Time again!

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PIC/S Data Integrity Draft Guidance Issued Last Week

Broughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:

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