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By Álvaro Spindola
on May 04, 2020

Currently, digital transformation is a hot buzzword, and it’s something that everyone wants to be a part of, even if they don't understand what it is or what it means. So, what is digital transformation really?

By Julian Oberle
on April 03, 2020

To stay competitive, every organization should consider what they can do to improve the quality of their products and services. In fact, having a clear understanding of your overall quality management system to ensure that you meet or exceed your customer’s expectations is a compelling way to improve your business.

That’s where the ISO 9001 Quality Management System (QMS) comes in.

The ISO 9001 is an internationally-recognized QMS standard that can benefit every organization or company. As a powerful business improvement tool, the ISO 9001 standard sets forth a strong QMS framework that produces many benefits for businesses.

By Henry Macartney
on April 02, 2015

Is cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more exposed.

By James Francum
on September 03, 2014

The methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.

By James Francum
on August 14, 2014

Not sure which pen to use? Although it seems like an amusing topic, your choice of writing utensil actually does make a difference when you're dealing with FDA documentation.

By Zuhdi Hussein
on July 15, 2014

Pharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful to institute quality by design standards (QbD).

By James Francum
on June 10, 2014

How do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they'll continue to do so consistently.

By Henry Macartney
on June 02, 2014

Your firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

By Zuhdi Hussein
on April 25, 2014

When GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it's critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could result in a regulatory authority taking action against your company.

By Zuhdi Hussein
on March 26, 2014

Medical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.