Attendees will learn how engineering document management delivers centralized access and control of GxP documents and CAD drawings in a secure, collaborative environment to improve quality processes and simplify compliance and system validation for FDA 21-CFR Part 11 and EMA Volume 4, Annex 11.
Register now for this live 50-minute webinar, hosted by Pharmaceutical-Technology.com, taking place on Wednesday, November 9, 2022, at 8:00am ET and 2:00pm ET. You can get access to the replay here.
The three panelists include:
- Raymond Kastle, Associate Director, Supply Chain at MSD
- John Niziolek, Associate Director Computer Systems Validation and Data Integrity, IPS
- Scott Lamond, Vice President of Marketing, Synergis Software
The presentation will address the top document management concerns that life sciences organizations face in a regulated industry with a focus on MSD’s specific background, challenges, and approach.
Mr. Kastle will also share MSD’s best practices and lessons learned for implementation and user adoption. Mr. Lamond and Mr. Niziolek will share their companies’ roles in supporting MSD’s document management implementation and validation.
Key Learning Objectives:
- Lower the cost and effort of compliance and validation
- Reduce risk of noncompliance with streamlined audits
- Eliminate costly mistakes and safety issues
- Simplify collaboration and accelerate projects
“In their pursuit of simplified compliance with FDA 21-CFR Part 11 and improved data integrity, traceability, an audit trail, and record retention, MSD turned to Synergis Adept,” says Scott Lamond, vice president of marketing at Synergis Software. “Adept provides a centralized platform for document access, workflow, and control that aligns engineering, maintenance, operations, and construction teams. It empowers life sciences companies to drive standards and reduce the risk of safety and compliance issues.”
Together, Synergis and IPS bring life sciences and biotech companies the best possible solution for engineering document management software coupled with expertise and resources to ensure compliance and validation.
“IPS has developed a deep understanding of the Adept platform and the Synergis implementation process,” says John Niziolek, associate director computer systems validation and data Integrity at IPS. “Our partnership provides every client with a compliant, consistent implementation experience and ensures they benefit from industry leading technology that addresses their regulatory compliance concerns.”
Synergis Adept is used by many of the top life sciences/biotech companies, including Johnson & Johnson, Thermo Fisher Scientific, Bayer, Agilent, Astellas, bioMérieux, Elanco, and many others.
About Synergis Software
Synergis Software, a division of Synergis Technologies, LLC, is a global leader in document management and workflow solutions and is the creator of Synergis Adept software. The Adept suite serves more than 130,000 users across dozens of industries including energy and utilities, life sciences, manufacturing, engineering and construction, and mining. Synergis' flagship product, Adept, provides fast, centralized access to design and business documents in a secure, collaborative environment. Adept Integrator makes it easy to connect enterprise applications so data and business processes flow seamlessly across the entire IT infrastructure.
Synergis Software was named the customer service leader in the global engineering information management market by analyst firm Frost & Sullivan and ranks in the Top 5 globally by Helpdesk International. Adept has over 30 top placements on software review site, G2, including fastest implementation, highest user adoption, and best support. Founded in 1985, Synergis is privately owned and headquartered in Bucks County, PA.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
About IPS
IPS is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consulting, architecture, engineering, construction management, and compliance services that allow clients to create and manufacture life-impacting products around the world. Headquartered in Blue Bell, PA-USA, IPS has over 3,000 professionals in 46 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.
