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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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Broughton Software To Attend BioNow - Business Pitching Event


Broughton Software will be attending the BioNow Business Pitching event taking place at Sci-Tech Daresbury on Wednesday 10th June. This event is a great networking opportunity with attendees given just 90 seconds to show what they offer and how it can add value. If you are looking for a LIMS system to manage sample test data, assist in compliance with regulatory bodies such as the MHRA and FDA and generate cost savings come along and learn more about LabHQ. Our Commercial Director, Andy Mooney (amooney@broughtonsoftware.com or 07903 708636) would be delighted to meet you at the event.

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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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Broughton Software To Attend Making Pharmaceuticals


Broughton Software will be attending the Making Pharmaceuticals exhibition in Birmingham, UK on Wednesday 29th April. 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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Do I Need A LIMS By 2017 - It Depends

Strategic decision-makers, QA and QC Laboratory Management, and IT professionals often ask whether they need a LIMS by 2017. Compliance with regulations is key to the decision along with managing customer expectations. Scott Schaefer writes in the Harvard Business Review that making good business decisions rests on assessing how the potential benefits and costs of a particular strategy pertains in each situation.

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Data Integrity Lessons From The US Masters Golf Tournament

World number one Rory McIlroy will be joined by the golfing greats as he hunts down history as well as his first Green Jacket when he steps out on to the first tee at Augusta National today, the home of the US Masters, the first of four major championships in professional golf. The return of four-time champion Tiger Woods has already heightened expectations around a tournament that needs little hyping.  Jack Nicklaus has the most Masters wins, with six between 1963 and 1986. Arnold Palmer and Tiger Woods have won four each, and five have won three titles at Augusta: Jimmy Demaret, Sam Snead, Gary Player, Nick Faldo, and Phil Mickelson. For the non-golfers, scoring the number of shots taken to complete a round of golf is not complicated, but current golfing regulations only permit hand-written records and signatures. As with many manual systems, mistakes can happen and can be costly.  

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A Guide To Best Practices: Meeting Client Expectations

Most businesses seek to nurture their relationships with clients, but successful businesses enchant their customers. They go above and beyond by creating a magical experience that earns repeat business and referrals. The magic flows when a company creates a good product and provides great service, supporting the client as their business grows. A dynamic company like Broughton Software seeks to meet their clients’ expectations through responsiveness, empathy, anticipation of needs, and honesty. Other practices include accountability, insight, and consistency.

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A Successful Show at CPhI Frankfurt

Thank you to the team at CPhI Worldwide for organising another great show this year in Frankfurt.  Over the three days, Broughton Software had the great opportunity to network with other companies meeting with current clients as well as prospective clients.  This show provides the best forum to meet professionals in the pharmaceutical industry to discuss and explore opportunities of working together.  With a hot topic this year of data integrity and regulatory compliance, we are excited to have created initial connections this year, and we look forward to growing these relationships in the future.  We will see you at the next CPhI Worldwide show in Paris, France next year!
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Meeting Fellow UK Businesses at The Pharmacy Show

As one of the largest UK pharmaceutical conferences, The Pharmacy Show provides a great forum to meet other pharmacy professionals in the community.  Located at the NEC Birmingham, The Pharmacy Show attracted many visitor and exhibitors of which Broughton Software had the pleasure to meet.  A hot topic this year was the regulations regarding electronic cigarettes, and we are excited to have had the opportunity to meet with so many companies in a continually evolving industry.  We look forward to attending another great show next year.

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The Evolution of LIMS

Before, computers and software data management in laboratories was a tedious and time consuming task.  With handwritten reports and charts, there was a higher probability of human error to occur.  Laboratory information management systems (LIMS) were only first developed in-house by the early 1980s.  In 1982, the first generation commercial LIMS was created providing the first automated reporting features.  By assigning laboratory functions to a centralized computer, productivity and functionality improved.As technology advances and work flow changes, the need for application specific features emerged.  This initiated the development of second generation LIMS which was possible by using third-party commercial relational databases through the use of minicomputers.  By the early 1990s the first client/server configuration was developed using a PC combined with the security of a minicomputer.  Functionality “appeared” quicker by splitting the data processing between several clients and the main database server.

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