CA-VALGENESIS
14.6.2022 14:02:05 CEST | Business Wire | Press release
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20220614005044/en/
Link:
Social Media:
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
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 01:00:00 CEST | Press release
Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and KeytrudaPhase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sour
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 00:00:00 CEST | Press release
Megaport DDoS Protection removes the trade-off between security, performance, and cost, offering rapid enterprise-grade mitigation. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing s
IFF Reports First Quarter 2026 Results5.5.2026 22:23:00 CEST | Press release
Delivered solid top and bottom line Q1 resultsProgressing disciplined sale process for Food Ingredients businessReaffirms Full Year 2026 Financial Guidance IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks t
Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 22:06:00 CEST | Press release
Strong FY 2026 Demonstrates Strategy and Operating Principles Are Delivering SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in
Sentinel Midstream Advances Texas GulfLink Deepwater Port5.5.2026 22:00:00 CEST | Press release
Marks Historic Milestone for U.S. Energy Export Infrastructure under the U.S.-Japan Trade Deal Sentinel Midstream LLC (Sentinel) today announced the commencement of its Texas GulfLink deepwater port (Texas GulfLink or the Project), marking a significant milestone enabled by funding received pursuant to the U.S.—Japan Trade Agreement. The project advances in coordination with the U.S. Department of Commerce and the Government of Japan and reflects the shared commitment to strengthening global energy security and expanding U.S. export infrastructure. Sentinel will lead the development of Texas GulfLink, overseeing construction, commercial operations, and long-term management of the terminal. Funding provided under the U.S.—Japan Trade Agreement, pursuant to Executive Order 14345 signed on September 4, 2025, underscores continued international confidence in U.S. energy infrastructure and supports the expansion of American crude oil exports to global markets. Upon this commencement, Texas
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