Life Science Consulting
November 1, 2021
How to Adopt an eQMS in 3 Simple Steps
A recent survey showed that 33% of the organizations surveyed use paper quality management systems; 60% use some paper and some digital; and 7% use no QMS yet. (source: Gartner peer insights) Quality...
Computer Systems Validation
Life Science Consulting
October 19, 2021
Implementing eQMS in a Regulated Environment
Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
Meet the Expert
Life Science Consulting
October 11, 2021
Meet the Expert: Maurice Weijers
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
Life Science Consulting
October 4, 2021
Development with the End in Mind – Overcoming Early-Phase Challenges
A drug must be safe and effective. Manufacturing of a drug product should consistently yield a predetermined quality. These are the undisputed goals for commercialization of a drug within our...
Life Science Consulting
September 29, 2021
5 Step Plan for Data Integrity Compliance
Are you always ready to be inspected for Data Integrity (DI) activities in your facility? Are compliance and data integrity aspects implemented in your organization’s QMS? Are the systems in your GxP...
Life Science Consulting
September 22, 2021
Five Steps Toward a Mature Data Integrity Culture
The corporate and quality culture has a significant effect on the maturity level of Data Integrity within a regulated company and should, therefore, be assessed and understood. To achieve the level...
Meet the Expert
Life Science Consulting
September 15, 2021
Meet the Expert: Bram Lardée
Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and...
MHRA
ICH GCP
September 9, 2021
How to Implement an Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...
Life Science Consulting
September 9, 2021
Prepare for Your Next Audit: A 5-Point GMP Checklist
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...