ValGenesis Acquires 4Tune Engineering, Extends Product Portfolio with Best-in-Class Risk Management and Continuous Process Verification Software Platforms
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.”
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.
Kevin Potts | VP, Marketing | email@example.com
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Alliance of Tech Founders Line up to Invest in the Next Generation of Global Innovators With $158m Series C Funding Round for Entrepreneur First29.6.2022 08:00:00 CEST | Press release
Entrepreneur First (EF), a scaleup investor in early stage founder talent, has raised a $158m Series C funding round from a group of veteran technology founders, including Patrick and John Collison, Reid Hoffman, Taavet Hinrikus and Matt Mullenweg. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220628005653/en/ Entrepreneur First co-founders Alice Bentinck and Matt Clifford (Photo: Business Wire) Bucking the trend of mounting layoffs and diminishing venture capital volumes across the startup world, owing to fears of a looming recession, the host of successful entrepreneurs and founders are backing EF to unlock opportunities for a diverse set of new global founders. EF’s impressive global roster of backers includes , John and Patrick Collison (co-founders of Stripe), Taavet Hinrikus (co-founder of Wise), Reid Hoffman (co-founder of LinkedIn), Matt Mullenweg (co-founder of Wordpress), Tom Blomfield (co-founder of Monzo and GoC
Mavenir Supports Provision of National Public Warning Systems in Germany and the United Kingdom29.6.2022 08:00:00 CEST | Press release
Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, today announced it is working closely with four tier one Mobile Network Operators (MNOs) across Germany and the United Kingdom to deliver Cell Broadcast (CB) functionality. CB, a technical specification maintained by 3GPP, is a method of sending messages to multiple mobile telephone users in a defined area at the same time. Mavenir is committed to supporting government agencies and MNOs in delivering high-quality alert and warning systems for use in times of national emergencies, natural disasters such as flash floods, wildfires or earthquakes, terrorist attacks or public unrest. Brandon Larson, Senior Vice President and General Manager of Mavenir’s Multimedia Business Unit said, “The floods experienced in western Germany July 2021, became one of the region's worst natural catastrophes in recent generations. Such unprecedent
Ipsen Announces U.S. FDA Priority Review for palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission29.6.2022 07:00:00 CEST | Press release
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its resubmitted New Drug Application (NDA) for investigational palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder. Ipsen is seeking approval of palovarotene, an oral, selective retinoic-acid receptor gamma (RARγ) agonist for the prevention of heterotopic ossification (HO; new bone formation outside of the normal skeletal system). The FDA has assigned 29 December 2022 as the Prescription Drug User Fee Act goal date, which is on track with anticipated regulatory submission timelines. “This FDA submission acceptance marks a significant milestone for those living with FOP in the U.S. where no approved treatment options exist today for this progressive and debilitating ultra-rare genetic disorder,” said Dr. Howard Mayer, Executive Vice President and Head of Research and De
The LYCRA Company Announces New Equity Ownership29.6.2022 01:49:00 CEST | Press release
The LYCRA Company, a global leader in developing innovative fiber and technology solutions for the apparel and personal care industries, today announced that a group of financial institutions, comprising Lindeman Asia, Lindeman Partners Asset Management, Tor Investment Management, and China Everbright Limited (“New Shareholders”), have gained full equity control of the Company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220628005988/en/ The LYCRA Company announces new equity ownership. Current management team led by CEO Julien Born continues to run business with full shareholder support. (Photo: Business Wire) The change of equity control follows the conclusion of the receivership process that started in February when the New Shareholders initiated an enforcement action against Ruyi Textile and Fashion International Group Limited, the former parent of The LYCRA Company, for loan defaults associated with its purchase of T
Logility to Acquire Network Optimization Provider Starboard Solutions28.6.2022 23:32:00 CEST | Press release
Logility, Inc., a leader in supply chain innovation powering the sustainable and resilient enterprise, today announced it has signed a definitive agreement to acquire Starboard Solutions Corp., a Traverse City, Michigan based innovator of supply chain network design software. Starboard creates an interactive supply chain digital twin of the physical supply chain network and uses gaming technology to provide an intuitive user experience where users can easily explore answers to "what if" questions like “What if I add another distribution point?,” “What if I consolidate production into one site?,” “What if I change up my supply mix?,” or “What if I re-route via a different port?” Starboard offers a unique supply chain visualization solution that can optimize for unknown locations, meaning users do not have to map their plans to a physical location. Applying Starboard’s rich set of reference costs with Logility’s lane rates and time data structures, users have the ability to quickly analy