Business Wire

ValGenesis Acquires 4Tune Engineering, Extends Product Portfolio with Best-in-Class Risk Management and Continuous Process Verification Software Platforms

Share

ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in manufacturing sciences and technologies (MS&T) that enable the world’s most successful life sciences companies to model their risk management programs and improve process performance across the entire GMP lifecycle.

The acquisition was initiated when ValGenesis leadership saw the strategic product synergy for customers requiring a complete and more integrated platform across the validation lifecycle focusing on Pharma 4.0. The acquisition was completed on June 6th, 2022.

A pioneer of 100% paperless validation technology with 30 of the top 50 global life sciences companies using ValGenesis VLMS as the system of record for their validation programs, ValGenesis has steadily expanded its product vision beyond core validation into a holistic manufacturing intelligence platform. The acquisition of 4TE accelerates that vision. 4TE’s advanced risk management platform (iRISK Platform®), used by 10 of the top 30 global life science companies, enables comprehensive risk management in the product lifecycle. In addition, 4TE’s continuous process verification software system (iSEE Platform™) enables real-time Stage 3 monitoring for process validation and supports Annual Product Quality Reviews (APQR). ValGenesis Validation Lifecycle Management System (VLMS) remains the industry standard for Stage 2 validation.

The acquisition also provides ValGenesis a boosted presence in the European and LATAM markets and access to a driven, talented team. The Lisbon office of 4TE will continue to orchestrate the development and go-to-market plans of iRisk and iSee with bolstering support from ValGenesis.

“The future never looked brighter for ValGenesis and 4TE employees, partners, customers, and the entire life sciences industry. This acquisition advances our Validation 4.0 strategy. 4TE’s product quality, individual talent, and passion for customers perfectly match ValGenesis’ corporate culture. We look forward to Prof. Dr. José Menezes and 4TE’s talented team joining ValGenesis, further cultivating a shared culture of innovation and driving even greater value for our customers.” says Dr. Siva Samy, CEO of ValGenesis. “As Pharma 4.0 becomes a reality, we continue to expand our product roadmap beyond core validation, driven by strong business values and commitment to the life sciences,” he stated.

The complementary functionality of their respective products ensures minimal product overlap. This presents minimal disruption and maximum upside for ValGenesis and 4TE customers. The combined offering is the most complete “validation lifecycle” platform on the market delivered by a single vendor. With a unified development team, a more robust roadmap, and an expanded services portfolio, ValGenesis is achieving its vision of becoming the de facto Validation 4.0 standard to lead life sciences companies in their journey toward Pharma 4.0.

Prof. Dr. José C. Menezes, Chairman, and founder of 4Tune Engineering, said, “We are excited to join ValGenesis. We share a similar vision about the challenges and solutions required by pharma, biopharma, and the new advanced medicinal therapeutic products, in terms of accelerated development and robust science- and risk-based approaches to better serve patients. Our integration into ValGenesis will provide our worldwide customers access to automated, systematic, and user-friendly tools for risk and validation lifecycle management programs to improve mission-critical business processes in the life science companies. Our unified company will also accelerate the development and innovation of future-ready solutions targeting advanced product portfolio management.”

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

For more information, visit www.valgenesis.com

For information on the acquisition, visit: https://www.valgenesis.com/4TE

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Kevin Potts | VP, Marketing | kevin.potts@valgenesis.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Spinal Cord Stimulation Delivers Improved Arm Function30.6.2022 18:30:00 EEST | Press release

ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces a Nature Neuroscience publication showing the potential for ONWARD’s ARCIM Therapy to restore movement and function in hands and arms after spinal cord injury. Regaining hand and arm function is the highest priority for many people with cervical spinal cord injury. Even mild functional deficits in hand and arm function lead to significantly reduced independence and quality of life. It has historically been challenging to develop new therapies for hand and arm function because their movements are complex and multidimensional. Researchers in today’s Nature Neuroscience publication investigated a potentially more effective approach to improving motor control of the upper limbs after spinal cord injury – an implantable neurostimulation system that modulates the spinal cord region involved in contr

NelsonHall Highlights the Strength of Mercans’ Global Employer of Record Services30.6.2022 17:00:00 EEST | Press release

“We are delighted that NelsonHall, the leading global analyst firm, has recognized Mercans as one of the fastest growing technology-driven global employer of record service providers. NelsonHall’s analyst report is a testament to the success of our EOR service line and demonstrates that our proprietary technology, combined with Mercans’ local presence in 160 countries, creates value for our customers and their employees,” said Tatjana Domovits, Group CEO of Mercans. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220630005419/en/ Salman Saeed - Head of EOR - Mercans (Photo: AETOSWire) Mercans’ global employer of record services delivery model is unique in the industry and focuses on the excellence in customer and employee experience through digitalization, employee-centric support, and in-country expertise. Mercans has invested significantly in developing a proprietary global payroll software, HR Blizz™ with 160 country cover

IBS Intelligence Recognizes Temenos as the #1 Best-Selling Banking Software in Six Categories; the Highest Awarded to Any Technology Provider30.6.2022 16:42:00 EEST | Press release

Temenos (SIX: TEMN) has been recognized as the market's leading open platform for composable banking in the IBS Intelligence Sales League Table (SLT). IBSi recognized Temenos as the leader in six categories, more than any other technology provider, including digital banking and channels, core banking and payments. The IBSi SLT 2022 assessed systems purchases made by over 1000+ banks across 250+ products from 60 suppliers. Temenos was ranked: #1 best-selling Universal Banking - Core Banking solution with 49 new named deals, maintaining its market leadership with 49% of total deals in the market. Temenos was the only major core vendor to increase its market share year-on-year #1 for Digital Banking and Channels – signing 79 deals, maintaining more than 50% market share in the Americas #1 in Payments Systems for retail banking, for the fourth consecutive year, with 43 new named deals #1 for Risk Management with 39 new name deals, 2X the number of deals of the next vendor #1 for Islamic Co

SES Appoints Kyle Pilkington as Chief Legal Officer30.6.2022 16:15:00 EEST | Press release

SES AI Corporation (NYSE: SES), a global leader in the development and manufacturing of high-performance lithium-metal (Li-Metal) rechargeable batteries for electric vehicles (EVs) and other applications, today announced the appointment of Kyle Pilkington to the position of Chief Legal Officer, effective July 1, 2022. Pilkington, who was previously VP, Legal, is based in the United States and replaces Joanne Ban on the company’s Executive Team. Ban is retiring from the position due to health reasons but will continue to serve SES as an advisor to the CEO. SES Founder & CEO, Qichao Hu said: “I am pleased to welcome Kyle to SES’s Executive Team. He brings a wealth of global experience particularly in securities laws matters and the effective oversight of legal, governance and regulatory matters and will play a key role working with me, our Board and the rest of our team as we continue to grow and strengthen the company. We also thank Joanne for all the valuable contributions over the pas

Sevan Ranked Among Top Firms on Engineering News-Record’s Lists for Fifth Consecutive Year30.6.2022 16:00:00 EEST | Press release

Sevan Multi-Site Solutions, Inc. (Sevan) has earned spots on lists published by Engineering News-Record (ENR) for the fifth consecutive year. Sevan, a global leader in innovative program management for clients with multiple sites, was ranked No. 36 on ENR’s Top 50 Program Management Firms and No. 57 on the Top 100 Construction Management-for-Fee Firms. “Our placement on the ENR lists is a result of the extraordinary commitment our team members have to delivering excellence for our clients and business partners,” said Jim Evans, Founder and CEO of Sevan. “We are honored to be listed alongside other industry leaders on this esteemed list. Congratulations to all!” The lists recognize firms finding new momentum in their business, and rankings are based on annual revenue. ENR conducts annual surveys that assess key segments of the construction industry and ranks companies within those areas. In 2022, Sevan was recognized as an Employee-Rated Great Place to Work® for the 9th consecutive year

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