One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.
Incorporating GDP through Lean Six Sigma
GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.
Internal Audit Readiness
Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure compliance with laws and regulations for the safety and efficacy of products or services. Internal audits are performed by qualified individuals who do not have direct responsibility for the area that is being audited. Audits may be an anxiety-inducing word but can become much more inviting through efficient preparation, and results from an audit may even be used as powerful tools to continuously improve on one’s QMS.
Empowering Your Workforce through Kaizen
Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
The Art of Addressing Non-Conformances in Operations
At one point or another, you likely took care of a non-conformance within your operations. Non-conformances in quality management are deviations from a specification, standard, or expectation. For example, a primary packaging label with illegible print or an out of specification quality control measurement.
Avoiding Statistical Biases in Clinical Trials
Clinical trials, when conducted with great care, are the safest and fastest way in having a treatment approved for use to improve public health1. A clinical trial is an investigation conducted under a protocol which assesses the efficacy and safety of a treatment in humans.