ISO 9001:2015 Certification Announcement

Flashback to May 2020 :  Despite the challenges that 2020 presented us, we decided to obtain our ISO 9001:2015 certification.  We managed this internal project undertaking the way we manage our client-projects; with effective project delivery management skills. So no nonsense, straight to the point, cost effective, quality-driven and focused on results.    Project duration: […]

Pinnaql recognised by Pharma Tech Outlook magazine.

We are honoured & proud to announce that Pinnaql has been selected as one of the Top 10 Compliance Consulting/Services Companies by Pharma Tech Outlook. Pioneers in bringing forth real-world solutions, news, product trends and solutions. In addition to winning this award, Pharma Tech Outlook magazine has featured an interview with Patrick Leyseele, Pinnaql’s founder & CEO.  They have […]

How to transition into Quality 4.0

Now more than ever digital transformation is profoundly changing manufacturing, processing and production industries all around the world. Recent research conducted by Raoul Sisodia and Daniel Villegas Forero indicates how to transition into Quality 4.0. In our blog, based on their research findings, we zoom in on Quality 4.0 initiatives. First things first: how can we […]

Addressing the human side of data

Data and technology alone will not create a data-driven organisation. Research indicates that the biggest obstacles to creating data-based businesses are not technical; they are cultural. Cultivating a data-driven culture does not happen overnight. That is why it is important to cultivate a data-driven mindset within your organisation. Creating an organisation culture where the quality mindset can […]

Why data quality, driven by technology, is a key to succes

The following statement is more relevant than ever in these unprecedented Corona-times;  without high-quality data, you are at a loss. If you turn on the news, data is being presented in order to inform us on the current status of the pandemic. On a daily basis we see proof of the criticality of data in making […]

How to ensure FDA CAPA compliance?

3 min read As stated in our blog about Mature Quality Management Systems, quality is the foundation of a successful business. In this blog we cover the important differences between corrective action and preventive action, the purpose of the CAPA subsystem and FDAs expectations from your CAPA process.  Let us start with the basics: what is CAPA?  CAPA is […]

How to adopt a continuous, proactive approach to quality.

3min read Last month, Pinnaql attended a public meeting to explore and better understand how stakeholders perceive and value the quality of pharmaceutical products. The public meeting was facilitated between the Center of Health Policy at Duke University in partnership with the FDA. The FDA leadership and staff provided comments on the Agency’s current thinking […]