Broughton Software Exhibiting at Making Pharmaceuticals
by Andy Mooney posted in Conferences, LIMS, Data IntegrityDeadline for Revised EU-GMP Annex 16 to become effective is Friday 15th April 2016
by Paul Moran posted in News, GMP requirementsThe European Commission has published the final version of the revised EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Deadline for coming into operation is 15th April 2016.
Invest in LIMS. Save Money. Generate Cash. Simple.
by Paul Moran posted in LIMS, Data Management, pharmaceutical manufacturing, cash flow, customer satisfaction, production cycleDecreased 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.
Broughton Software Attending Making Cosmetics 2016
by Andy Mooney posted in Conferences, LIMS, NewsMHRA Guidance for Specials Manufacturers
by Andy Mooney posted in LIMS, News, environmental monitoring, unlicenced specials, MHRA Guidance, EU GMP Annex 11 and 15, GMP requirements, radiopharmaceuticals, Product Quality Review (PQR)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.
Is your LIMS too complicated?
by Theresa Webster posted in LIMS, Data Management, Data Integrity, Project Management, Process Improvement, Production Environment, Laboratory Environment, process improvement software
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.
Environmental Monitoring - Why Does It Matter?
by Andy Mooney posted in LIMS, Data Management, environmental monitoring, pharmaceutical manufacturing, microbiological contamination, standard operating procedures (SOPs), FDA, MHRAMicroorganisms 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.
Data Integrity update following the MHRA industry consultative committee meeting for GMP and GDP
by Paul Moran posted in Insider, News, Data IntegrityThe minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on www.gov.uk.
Broughton Software signs up for Making Pharmaceuticals 2016
by Andy Mooney posted in Conferences, LIMS, NewsBuzz About Lab Innovations 2015
by Andy Mooney posted in Conferences, LIMS, News, LabInnovationsThe 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.