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With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.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

When you walk into the lab to start your shift, do you get excited to launch your LIMS or do you dread to use it because it’s too complicated? We all want to be excited to use LIMS, but in reality, there are so many reasons why we’re stuck with this complicated beast of a LIMS that we don’t want to use. “The business can’t afford to upgrade the system”, “We don’t have time to manage the project if we did change systems”, “The business bought this system without consulting the users so we have to use it” – the list of reasons could go on and on. Despite all the obvious reasons for not being excited to use a LIMS, there are genuine quality operational concerns for a lab using a LIMS too complicated for its users. These operational concerns are what I call the ‘side-effect’– muda.

The minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on www.gov.uk.

During an enjoyable, busy and informative CPhI show in Madrid, what did the team at Broughton Software learn?

It was wonderful to see such a great turnout at the UK NHS Pharmaceutical Quality Assurance and Technical Services Symposium 2015.  The Symposium included several informative break-out sessions to discuss current key topics facing the industry.  Dr. Julian Smith (Viridian Pharma Ltd) and I had the opportunity to host one of the sessions to cover ICH analytical method validation and data integrity.

Overheard in the ABC Pharmaceuticals QC lab, "He understands the regulatory benefits of LIMS, but my boss also wants to see a tangible return on investment. Help!"

A major driver for implementing LIMS in regulated industries is the increasing focus of the MHRA, FDA & HPRA on the hot topic of data integrity. Failure to present a quality system that meets the requirements reflected in the ALCOA acronym ( data must be attributable, legible (permanent), contemporaneous, original and accurate) could lead to a loss of licence and result in a devastating impact on revenue.

Most Quality Management Systems will have evolved over time. For many this will mean the design and use of custom excel spreadsheets to manage Quality Control test data. With the recent updated regulatory guidelines with respect to data integrity, how compliant are these spreadsheets?