PA-SYNERGIS/MERCK/IPS
7.11.2022 15:10:40 CET | Business Wire | Press release
Synergis Software, a global leader in engineering document management and workflow solutions, today announced they will participate in a collaborative, live panel with leaders from Merck, known as MSD outside of the United States and Canada, and IPS-Integrated Project Services, LLC (hereinafter IPS), a recognized leader in Engineering, Procurement, Construction Management and Validation (EPCMV), to present one of the many ways MSD is leveraging the Synergis Adept platform to simplify compliance and validation across their global facilities.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221107005177/en/
Engineering Document Management for Simplified Compliance & System Validation (Graphic: Business Wire)
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221107005177/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
New Auction Record Set as Falcon Sells for AED 1.5 Million at ADIHEX 202629.8.2026 23:54:00 CEST | Press release
Qarmousha Pure Ultra White falcon sells for AED 1.5 million at the Abu Dhabi International Hunting and Equestrian Exhibition 2026 (ADIHEX) falcon auction Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler’s Representative in Al Dhafra Region and Chairman of the Emirates Falconers’ Club, the fifth auction held as part of the 23rd edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) 2026 attracted remarkable turnout, culminating in the sale of a Qarmousha Pure Ultra White falcon for AED 1.5 million (USD 408,000). The sale marks the highest price achieved at any auction during this year’s edition of the exhibition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260829032621/en/ Qarmousha Pure Ultra White (Photo: AETOSWire) This forms part of the largest auction programme in the exhibition’s history, held under the theme “A Legacy of Pride,” organised by ADNEC Group, a Modon
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro
Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 11:00:00 CEST | Press release
Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
