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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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Broughton Software Exhibiting at Making Pharmaceuticals

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Invest in LIMS. Save Money. Generate Cash. Simple.


Decreased operational costs, increased capacity, and improved cash flow often follows the implementation of a Laboratory Information Management System (LIMS). Many laboratories have realised savings due to the installation or upgrading of a LIMS, an investment that pays off in the form of both hard and soft benefits. The hard benefits improve cash flow while the soft benefits, such as employee morale and customer satisfaction help reinforce them.

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Broughton Software Attending Making Cosmetics 2016

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MHRA Guidance for Specials Manufacturers

Manufacturers of specials have guidance to consult as the Medicines and Healthcare Products Regulatory Agency (MHRA) has released an interpretation of GMP requirements for manufacturing unlicenced specials. The guidance titled, "MHRA Guidance for Specials Manufacturers," is presented in a question and answer (Q & A) format for ease of reading and reference. The Manufacturing Specials (MS) licence includes radiopharmaceuticals. The following is selected advice, however, the 41-page guidance is extensive and covers many issues relating to specials manufacturing.

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Is your LIMS too complicated?

 

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.

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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.

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Broughton Software signs up for Making Pharmaceuticals 2016

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Buzz About Lab Innovations 2015

The weather outside may have left a bit to be desired but inside the Pavilion at the NEC in Birmingham there was a real buzz about Lab Innovations 2015. Broughton Software were delighted to be part of the UK’s largest Laboratory show that took place on 4th and 5th November and, judging by the number of visitors to our stand, LabHQ LIMS is generating a buzz of its own in the world of Laboratory Information Management Systems. A big shout out to everyone who we met during the show.

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