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


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.


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.


PIC/S Data Integrity Draft Guidance Issued Last Week

Broughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:


The FDA issues updated Data Integrity Guidelines

With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.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


Environmental Monitoring - Why Does It Matter?

Microorganisms are found everywhere. This can be in the air and water, on skin and other surfaces. When microbiological contamination occurs in pharmaceutical manufacturing, product batches are wasted, risking potential recalls and plant shutdowns. The effect of the contamination can include lost time and money for manufacturers, drug delays and shortages, and related loss of public confidence, potential fines and even criminal consequences.