42Q Announces GAMP 5 and Part 11 Compliance
for Cloud-Based Manufacturing Execution System
San Jose, Calif., July 12, 2016 – 42Q, a leading provider of cloud manufacturing execution systems (MES), today announced that the company’s products are Good Automated Manufacturing Practice (GAMP 5) and Part 11 compliant. GAMP 5 is the current methodology established by the International Society for Pharmaceutical Engineering (ISPE) and sets forth the best practice approach for validations within the medical industry. 42Q’s MES solution was recently assessed for compliance with GAMP standards by Excellis Health Solutions, LLC.
42Q delivers a comprehensive and proven cloud MES solution, with unique on-demand pricing that eliminates capital expenditure and other upfront costs. 42Q has been used as the MES core for many years in medical manufacturing facilities producing both high volume medical devices, along with highly complex diagnostic imaging equipment. Today, 42Q is deployed in twenty medical manufacturing facilities having International Organization for Standardization (ISO) 13485 certification, and eight facilities having Food and Drug Administration (FDA) registration for Class 1, 2 or 3 medical products.
During a FDA audit, the ability to produce correct, clear and verifiable quality records in a timely manner is essential. GAMP 5 represents a general medical industry alignment regarding the use of a risk-based approach to qualification and validation for automated systems and new equipment. Compared with previous versions, GAMP 5 provides additional focus on risk control and quality management. Validation efforts must be independent of other product risk assessments and instead investigate the impact of automation and software systems on patient safety, product quality and data integrity.
“42Q’s leadership in cloud based MES is strengthened for medical product manufacturers by our confirmed compliance with GAMP 5 and Part 11. 42Q customers in the medical device, pharmaceutical and life sciences industries can be confident that their quality systems meet the latest standards for electronic device history records,” said Bob Eulau, CEO of 42Q. “The combination of Cloud-Based MES and Part 11 compliance accelerates manufacturers ability to rapidly implement robust solutions in a challenging regulatory environment.”
In March 2016, a GAMP assessment was conducted by Excellis Health Solutions to determine the compliance of 42Q’s cloud MES with GAMP 5 methodology. “We evaluated 42Q’s MES and found it to be fully compliant with GAMP 5 requirements”, said Karan Narang, executive vice president at Excellis Health Solutions. “Moreover, we assessed 42Q operating as the MES at a large medical manufacturer, and found the performance and implementation to be robust in terms of quality management, product lifecycle management, product test and documentation management.”
“Process validation is a key part of the quality system for medical device manufacturers, and validation of manufacturing software and automated systems has become essential. Complying with regulatory requirements is important to obtain premarket approvals for new and modified medical devices,” said Srivats Ramaswami, CTO at 42Q.
Marketing matters: from IBM to Kyndryl
Prior to joining Kyndryl as Chief Marketing Officer, Maria had a 25-year career at IBM, most recently as the tech giant’s CMO where she oversaw all marketing professionals and activities across North America, Canada and Latin America. She has held senior global marketing positions in a variety of disciplines and business units across IBM, most notably strategic initiatives in Smarter Cities and Watson Customer Engagement, as well as leading teams in services, business analytics, and mobile and industry solutions. She is known for her work with teams to leverage data, analytics and cloud technologies to build deeper engagements with customers and partners.
With a passion for marketing, business and people, and a recognized expert in data-driven marketing and brand engagement, Maria talks to Business Chief about her new role, her leadership style and what success means to her.
You've recently moved from IBM to Kyndryl, joining as CMO. Tell us about this exciting new role?
I’m Chief Marketing Officer for Kyndryl, the independent company that will be created following the separation from IBM of its Managed Infrastructure Services business, expected to occur by the end of 2021. My role is to plan, develop, and execute Kyndryl's marketing and advertising initiatives. This includes building a company culture and brand identity on which we base our marketing and advertising strategy.
We have an amazing opportunity ahead at Kyndryl to create a company brand that will stand apart in the market by leading with our people first. Once we are an independent company, each Kyndryl employee will advance the vital systems that power human progress. Our people are devoted, restless, empathetic, and anticipatory – key qualities needed as we build on existing customer relationships and cultivate new ones. Our people are at the heart of this business and I am deeply hopeful and excited for our future.
What experiences have helped prepare you for this new opportunity?
I’ve had a very rich and diverse career history at IBM that has lasted 25+ years. I started out in sales but landed explored opportunities at IBM in different roles, business units, geographies, and functions. Marketing and business are my passions and I landed on Marketing because it allowed me to utilize both my left and right brain, bringing together art and science. In college, I was no tonly a business major, but an art major. I love marketing because I can leverage my extensive knowledge of business, while also being able to think openly and creatively.
The opportunities I was given during my time at IBM and my natural curiosity have led me to the path I’m on now and there’s no better next career step than a once-in-a-lifetime-opportunity to help launch a company. The core of my role at Kyndryl is to create a culture centered on our people and growing up in my career at IBM has allowed me to see first-hand how to prioritize people and ensure they are at the heart of progress in everything Kyndryl will do.
How would you describe your leadership style?
I believe that people aren't your greatest assets, they are your only assets. My platform and background for leadership has always been grounded in authenticity to who I am and centered on diversity and inclusion. I immigrated to the US from Chile when I was 10 years old and so I know the power and beauty that comes from leaning into what makes you different from other people, and that's what I want every person in my marketing organization to feel – the value in bringing their most authentic self to work every day. The way our employees feel when they show up for themselves authentically is how they will also show up for our customers, and strong relationships drive growth.
I think this is especially true in light of a world forever changed by the pandemic. Living through such an unprecedented time has reinforced that we are all humans. We can't lead or care for one another without empathy and I think leaders everywhere have been reminded of this.
What’s the best leadership advice you’ve received?
When I was growing up as an immigrant in North Carolina, I often wanted to be just like everyone else. But my mother always told me: Be unique, be memorable – you have an authentic view and experience of the world that no one else will ever have, so don't try to be anyone else but you.
What does success look like to you?
I think the concept of success is multi-faceted. From a career perspective, being in a job where you're respected and appreciated, and where you can see how your contributions are providing value by motivating your teams to be better – that's success! From a personal perspective, there is no greater accomplishment than investing in the next generation. I love mentoring younger professionals – they are the future. I want my legacy as a leader to include providing value in work culture, but also in leaving a personal impact on the lives of professionals who will carry the workforce forward. Finding a position in life with a job and company that offers me a chance at all of that is what success looks like to me.
What advice would you give to your younger self just starting out in the industry?
I've always been a naturally curious person and it's easy for me to over-commit to projects that pique my interest. I've learned over years of practice how to manage that, so to my younger self I’d say… prioritize the things that are most important, and then become amazing at those things.