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Broughton Software to attend the UK’s Leading Laboratory Show – Lab Innovations

With the exhibition season now in full flow, Broughton Software is delighted to be exhibiting at the UK’s number 1 show for laboratory professionals, Lab Innovations. Taking place at the NEC in Birmingham from 4-5th November we are looking forward to meeting Quality Control and QA professionals who are looking for ways to achieve regulatory compliance and generate cost savings in their Quality Control Labs.

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QC Laboratory data integrity discussions at NHS Symposium

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.

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Return on Investment: Beyond the Regulatory Benefits of LIMS in a QC Lab

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.

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Broughton Software to attend NHS Pharmaceutical Quality Assurance and Technical Services Symposium

Broughton Software are delighted to be attending the NHS Pharmaceutical Quality Assurance and Technical Services Symposium at Chesford Grange Hotel, Warwick from 15-16th September. Following the recent addition of new clients supplying Pharmacy Specials to the NHS, Paul Moran and Andy Mooney will be at the show to listen to attendees’ regulatory challenges and to evaluate how LabHQ LIMS could help to overcome them.

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LabHQ LIMS to be presented at LabInnovations

It’s going to be a busy Q4 at Broughton Software with the launch of its latest version of LabHQ LIMS and attendance confirmed at a number of industry events. We are delighted to announce that this will include the number 1 UK laboratory show, LabInnovations which is held at the NEC in Birmingham from 4-5th November. If you are looking for a LIMS system to manage sample test data and assist in compliance with regulatory bodies such as the MHRA and FDA we may be able to help. Our product, LabHQ, is a LIMS for QC labs in a manufacturing or contract test environment. It is designed to streamline the sample test process, generate cost savings and facilitate compliance with the data integrity requirements of regulatory bodies such as the FDA and MHRA

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When the Regulators arrive, how compliant is your Excel spreadsheet?

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?

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GxP Project Management Made Simple

GxP compliance in the pharmaceutical industry is a hot topic. With increasing numbers of drugs coming onto the worldwide market, it is important for pharmaceutical companies to make sure they operate within industry guidelines from development to production. Many companies use a Laboratory Information Management System - or LIMS - to facilitate compliance and ensure they have everything in place during regulatory body audits.

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What Does A LIMS And The Empire State Building Have In Common?


Lesson 1: Don’t create an over-sized beast you want to get rid of.

What does the Empire State Building and a Laboratory Information Management System (LIMS) have in common? They are often associated with over-sized beasts! Like King Kong trying to escape the Boeing P12 airplanes, LIMS deployments are often frustrating as they become over-sized because of their complexity. The complexity starts with the LIMS product. Has it been designed to simplify complexity? Feedback from users of complex LIMS often includes errors crept in and users were not using the product properly because it was simply too much! Their LIMS software did too many things – it had too many options. The number of options stressed the users out and they simply chose to stop using the system correctly. LIMS users wanted, "Fewer buttons on the screen, not more, and to make it intuitive and fun to use," was the general feedback.

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Press Release: Data Integrity To Be Included In MHRA Pre-Inspection Compliance

 

A LIMS can help businesses meet regulations.

Yorkshire, UK (May 19, 2015) - On 17th of March, 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) released the newly revised and updated GMP pre-inspection compliance report templates and guidance. The newest format of the report includes guidelines for the inclusion of data integrity policies that will now be added in order for compliance to be met.

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Data Integrity to Be Included in MHRA Pre-Inspection Compliance Report

On 17th of March, 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) released the newly revised and updated GMP pre-inspection compliance report templates and guidance.  The newest format of the report includes guidelines for the inclusion of data integrity policies that will now be added in order for compliance to be met.

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