ZenQMS Blog » The-business-of-quality
Panos Boudouvas
By Panos Boudouvas on April 07, 2020

Amidst this turbulent moment in our lives, with a global pandemic threatening us and our loved ones directly, and the specter of the coming economic recession already making waves, it is important to acknowledge that the hard work of life sciences development and manufacturing continues.  And while global regulatory requirements remain in place, many companies will be forced to stretch budgets further and possibly with fewer FTEs (due to cuts). And in a new complication-- teams will have to truly do more (or everything!) remotely-- manage policies and related training compliance, investigate deviations, manage change controls, host/conduct audits, sign/review documents, etc. 

Panos Boudouvas
By Panos Boudouvas
on November 12, 2019

John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing  over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder.  That was just one of many times that he observed teams not taking a risk-based approach to systems validation. 

Panos Boudouvas
By Panos Boudouvas
on October 31, 2019

Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.

By Judy Carmody
on October 01, 2019

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

Celia Brown
By Celia Brown
on September 25, 2019

The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future. 

Panos Boudouvas
By Panos Boudouvas
on July 03, 2019

Effective  quality leaders know that securing executive support and buy-in are key factors  in successfully selecting and implementing an  eQMS. Convincing skeptical C-suite colleagues of the strategic implications and costs of  the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks.   It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI).