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.
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.
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.
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 (email@example.com or 07903 708636) would be delighted to meet you at the event.
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.
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.
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.
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.
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.