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.

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.

Broughton Software are delighted to be attending the NHS Pharmaceutical Quality Assurance and Technical Services Symposium at The Crowne Plaza Hotel, Chester from 20-21^st September.

Broughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:

In breaking news today, the MHRA just released a new 14 page consultation document for data integrity. As quoted from the MHRA:

Broughton Software are excited to be exhibiting for the first time at the Food and Drink IT Summit at The National Motorcycle Museum in Birmingham. Taking place on Tuesday 5th July, the event is an annual gathering of the leading food and beverage companies interested in improving their business through data, IT and software.

You by now have learnt, or heard, about the latest guidance from regulatory bodies such as the FDA and MHRA with respect to Data Integrity. You have probably also heard about the ‘end of 2017 deadline’.

What exactly is a deadline? The Oxford English dictionary defines it as ‘the latest time or date by

With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.

The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records. It also includes recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records are monitored, and can only be used by authorized personnel.

First let’s address implementing change. This could be considered a lifelong study. I’ll cover this succinctly before moving onto problem solving and the root cause analysis pocket guide providing a simple technique for both. If we get the problem solving bit right then implementing change becomes a whole lot easier.