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.
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.
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.
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.