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
Smartstream Smart Agents Delivers 70% Reduction in Back-Office Investigation Time, Proving the Case for Autonomous Operations26.3.2026 10:30:00 CET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that Smart Agents - its agentic AI solution for bank back-office operations is delivering measurable, transformational impact, with pilot results showing a 70% reduction in investigation time per user, per break. As the industry accelerates toward a service as software (SaS) operating model, and allowing more work to get done from software solutions, Smartstream is embracing this approach with agentic AI. The results validate a fundamental shift in how financial institutions approach exception management. In one benchmark scenario, the manual processing of 500 exceptions, typically requiring 116 hours of team effort, was reduced to just a few hours under fully autonomous operations. This eliminates swivel-chair workflows and frees up teams to focus on risk oversight, decision making, and higher-value activities. Institutions continue to struggle with back-office w
Infobip Supports Thousands of Startups and Scaleups Through Startup Tribe Programme26.3.2026 10:00:00 CET | Press release
In the first five years of the programme, Infobip has provided significant value in products and services to members, helping them build and scale customer communications worldwide Global AI-first cloud communications platform Infobip, which is celebrating its 20th anniversary this year, has supported thousands of startups and scaleups from over 120 countries in the first five years of its Startup Tribe Programme. Infobip launched its Startup Tribe Programme in May 2021 to help mission-driven startups and scaleups to build and manage their customer communications and engagement strategy and grow their business. It does this by providing access up to $60,000 in credits for Infobip’s services and its global network of advisors, investors, and accelerators. In the first five year, Infobip has provided millions in the value of products and services to its programme members. By eliminating the need to build a global communications infrastructure from the ground up, Infobip’s programme enabl
LTM Positioned as a Leader in ISG’s Provider Lens™ Evaluation for Oracle Cloud and Technology Ecosystem 202526.3.2026 09:58:00 CET | Press release
Recognition highlights LTM’s leadership across key quadrants in the United States and Europe LTM, the Business Creativity partner to the world’s largest enterprises, has been recognized as a Leader in multiple quadrants in the ISG Provider Lens™ Oracle Cloud and Technology Ecosystem 2025 reports for both the United States and Europe by Information Services Group (ISG), a leading global technology research and advisory firm. The ISG Provider Lens™ study evaluates leading Oracle ecosystem service providers across critical capability areas, including: Professional Services Managed Services OCI Solutions and Capabilities LTM’s positioning as a Leader across key quadrants in both regions reflects its strong Oracle ecosystem expertise, AI-led transformation approach, and proven track record in delivering large-scale enterprise cloud modernization programs. In its 2025 study, ISG highlights that the Oracle ecosystem is undergoing a fundamental shift toward AI-native architectures, multicloud-
Bureau Veritas Strengthens Global Sustainable Finance Capabilities with Expanded Climate Bonds Approved Verifier Status26.3.2026 08:30:00 CET | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), is pleased to announce the expansion of its geographical scope as an Approved Verifier under the Climate Bonds Standard and Certification Scheme. Additional offices in China, Japan, India, and France are now formally listed in the Climate Bonds Verifiers Directory. This expansion builds on Bureau Veritas’ established role since the approval of its Brazilian office in 2020, further enhancing its ability to support issuers with high-quality, independent verification services across key markets. “Our expanded presence as an Approved Verifier under the Climate Bonds Standard reinforces Bureau Veritas’ commitment to advancing credible, high‑integrity sustainable finance”, said Marc Roussel, Executive Vice President, Urbanization and Assurance at Bureau Veritas. “With verifier capabilities available across key markets, we continue to deliver local expertise with global assurance standards; boosting mark
Invivoscribe® Expands IVDR Portfolio with IdentiClone® Dx IGH Assay Certification26.3.2026 06:13:00 CET | Press release
IdentiClone® Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements in patients with suspected B-cell lymphoproliferative disease. Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026. The IVDR replaces the former In Vitro Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. Under IVDR, in vitro diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as IdentiClone Dx IGH, are considered high-risk tests that play a critical role in disease diagnosis an
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