Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in ensuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA Regulatory Requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:
Quality Management 2.0 Blog
Topics: IBS America, Process Management Software, Mary McAtee, FDA Validation, Risk Management Software, Risk Assessment Software, FDA Validation Software, Life Science Software Validation, 21 CFR Part 11 FDA Validation Software
Andrew Zolli, coauthor of the book "Resilience: Why Things Bounce Back," in a recent Harvard Business Review interview relates a story from the auto industry that illustrates the importance of resilience to an organization. He also discusses the strategies for improving the resilience of an organization.
Topics: Automotive Quality Management, Process Control, Manufacturing Software, Supply Chain Management, Enterprise Quality Management, Process Management Software, Enterprise Risk Management, Risk Management Software, Risk Management, Manufacturing Productivity, Enterprise Manufacturing Software, Crisis Management, Resilience, Andrew Zolli
Today’s quality managers face a myriad of challenges, from monitoring quality of goods to organizing documentation to managing compliance with multiple regulations. Many quality departments address each of their functions with a separate set of practices, leading to duplicated efforts and disorganized documentation. This is compounded by a limited, fragmented use of technology to automate processes. If any of the following scenarios apply to your organizations' day-to-day activities, quality management software may be a prudent and profitable option to consider.
According to a recent article from Quality Progress magazine, Toyota and its brands top the Consumer Reports list for Auto Reliability. The luxury nameplate Lexus came in second of the 2011 rankings, Toyota in the fifth slot, with the youth-targeted Scion model topping the list with the #1 Auto Reliability Survey slot, beating out all other competitors for the second year in a row. (Source: QP Magazine, December 2011 edition, Brett Krzykowski)
The brand is also known for its development of the Toyota Production System, which is a socio-technical system, that comprises its quality management systems philosophy and practices. The following are some interesting excerpts of a 2009 presentation of the Toyota Way Principles that shed some light on its quality assurance management.1) Long Term Philosophy
Base your management decisions on a long term philosophy, even at the expense of short term financial goals.
2) The Right Process Will Produce the Right Results
Create continuous process flow to bring problems to the surface. Use visual control so no problems are hidden, and use reliable, thoroughly tested process management software technology that serves your people and processes.
3) Add Value to the Organization by Developing Your People and Partners. Grow leaders who thoroughly understand the work and live the philosophy. Respect your extended network of partners and suppliers by challenging them and helping them to improve. (Source: 14 Toyota Way Principles, 2009)
Manufacturers improve shop floor quality control by consistently monitoring their production processes and eliminating factors that can damage product quality. But identifying and documenting defects can be a challenging, time-consuming process. Quality managers often feel caught between a desire to take proactive measures against factors impacting production, and budgetary and time constraints that prevent them from performing statistical process control. Quality assurance software from IBS is the solution.
Processes and systems can be easily confused terms in the quality management systems space. In reality, the terms are in fact related to each other, but represent two different entities: a process is a set of interrelated / interacting activities that transforms inputs into outputs, while a system is a set of interrelated / interacting processes.
IBS America, Inc. queried some of our customers that have been using the CompliantPro document control software to gain insight on our products and services. This month, customers were asked to respond with their top 5 features of the CompliantPro product. We've highlighted one of our customers' responses here.
Quality Management 2.0 represents an evolutionary technology-based advance - similar to what's happened with web 2.0, or marketing 2.0. The common 2.0 “theme” is all about building community, such as web 2.0 does through social media. This enables people to work together better through communication and transparency.
Introducing the newest IBS America, Inc. co-sponsored whitepaper now available for download: "Closed Loop Quality Management: Creating Visibility and Reducing Risk across the Value Chain"