LABORATORY INFORMATICS GUIDE 2015 | CHANGE MANAGEMENT
analysis will substitute for off-line (batch oriented) manufacturing processes. International regulatory authorities such as ICH, FDA and ISPE are evaluating these new processes intensively and developing new best practice workflows. These processes will change how QA/QC
Forces of change ➤
efforts in the laboratory and manufacturing operations. Scientists should be expecting ‘more for less’ – resulting in fewer points of failure during operation, less customisation of software, and automated, consistent documentation to reduce validation efforts.
TRACEABILITY INCREASES DATA INTEGRITY A non-invasive, end-to-end strategy creates full lifecycle traceability from R&D to manufacturing operations. Agile processes will increase product releases more rapidly, decrease engineering change cycle times, and increase asset and resource utilisation significantly. Automating correlation of real-time
manufacturing data to process and product specifications decreases cycle times. Process analytical techniques (PAT) technology is expected to grow significantly in the next decade. Over time, in-line, @line and on-line
laboratories operate over the next decade. The QC functions are expected to decrease while the laboratory will change into a knowledge centre to support the new business processes. ERP and PLM applications will integrate the QC laboratory more cost effectively into the value chain. Electronic Lab Notebooks (ELN) and Lab Execution Systems (LES) will play a crucial role in increasing end user adoption to support knowledge management.
MANAGING THE CHANGE The process of change management starts at the source. New technologies will have a significant impact how operating budgets will be defined in the next decade. The days when software was purchased as a capital investment (Capex) are changing to a new model based upon a ‘pay-as- you-go’ philosophy (Opex). In the traditional enterprise business software
market, customer relations management (CRM) applications such as
SalesForce.com started this business model. Popular applications, such as Photoshop and Office 365, are following rapidly. It can be expected that scientific software will follow this model in the years to come.
Laboratory data management abbreviation shortlist
CAPA/PACA – Preventive Actions and Corrective Actions
CDS – Chromatography Data System
CRM – Customer Relationship Management
ERP – Enterprise Resource Planning
LES – Lab Execution System
LIMS – Laboratory information management system
MES – Manufacturing Execution Systems
PLM – Product Lifecycle Management
Process to eliminate causes of non-conformities: CAPA is a concept within good manufacturing practice (GMP). PACA puts the preventive mind-set first
Collects and analyses chromatographic results delivered by chromatography systems.
Manages communications and information with customers ELN – Electronic Lab Notebook Software designed to replace paper laboratory notebooks
Integrates internal and external management information across an entire organisation, embracing finance, manufacturing, sales and service, customer relationship management
Software to assist work in step enforcement for laboratory test method execution
LIMS software is used to automate a wide variety of analytical laboratory tasks from sample management, instrument calibration, quality assurance, quality control, data entry and workflow processes
Manages manufacturing operations in factories. Integrating quality test requests, sample lots, statistical process data, quality test results, product certificates and testing progress
The process of managing the entire lifecycle of a product from inception, through engineering design and manufacture, to service and disposal of manufactured products
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www.scientific-computing.com/lig2015
Peter Boogaard is an independent laboratory informatics consultant and founder of Industrial Lab Automation, which provides services to address harmonisation, integration, and consolidation of business processes in development and manufacturing. Industrial Lab Automation organises the Paperless Lab Academy, for which Scientific Computing World is media sponsor. Taking place in Barcelona, the 2015 event focuses on how to Manage the change process in R&D and QA/QC laboratories in pharmaceutical, biotechnology, consumer goods, and chemical industries. The interactive congress offers actionable insights on how to adopt a new mind-set in daily work. The academy includes 16 hands- on workshops, many practical presentations, a networking reception, conference dinner, and live demonstrations from more than 20 leading vendors.
www.paperlesslabacademy.com
References 1
2
Software celebrates its 60th anniversary in 2015 – Happy Birthday!
It is 60 years since the first software company was founded. In the early days of the computer industry, software was written only by the hardware vendors and the IT departments that had those devices in their care. The Computer Usage Company (CUC), which was founded in 1955, is generally considered to be the first company to develop and sell software independently. It was a scientific software company, for its first project was to develop a program to simulate the flow of oil. Although it ended badly for the CUC, which went bankrupt in 1986, the software industry has expanded beyond anyone’s imagining. More than 10 million software engineers are now employed worldwide. By the year 2020, there are expected to be more than 1.4 million job openings related to computers. The business software market is now a $300 billion industry that serves tens of millions of companies across the globe1
. Software suppliers are themselves under
pressure to maintain their maintenance, support and license revenues. Community collaboration and social networking is changing the value of traditional vendor helpdesks. Have you ever tried typing a question you would like to ask your helpdesk into Google? What was the response time? Initiatives such as the Allotrope Foundation will address the need to create sustainable interchangeable data standards, allowing users to be less dependent on proprietary scientific data formats2
. l
Source Capterra -
http://www.capterra.com/ history-of-software
2014 - Joining Up The Laboratory - Scientific Computing World by Peter Boogaard
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