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REJIMUS Expands In 21 CFR Part 11 Software Validation Services for CPG Supply Chains

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REJIMUS empowers FDA-regulated businesses throughout the GPG supply-chain to more quickly audit, validate, document and maintain electronic systems – including AI-enabled workflows – within their existing quality and compliance programs subject to regulations under 21 CFR Part 11.

NORTH RICHLAND HILLS, Texas, Aug. 26, 2026 /PRNewswire-PRWeb/ — REJIMUS, Inc., a preeminent regulatory management consultancy and SaaS provider serving FDA-regulated consumer-product industries in the US, today announced the expansion of its 21 CFR Part 11 Software Validation Services.

“Food, supplement, cosmetic and OTC companies are adopting cloud systems and AI at the same speed as the rest of the market, but many do not have software validation expertise in-house or even know it is required,” said Brandon M. Griffin, CEO of REJIMUS, Inc.

The offering helps food and beverage, dietary supplement, cosmetic and over-the-counter (OTC) drug companies implement and maintain Part 11 compliance over their computerized systems, AI integrated workflows, and electronic record keeping practices to ensure such systems operate in compliance for their intended use throughout the operational life-cycle.

Electronic quality management systems, manufacturing execution systems, standalone document-control systems, laboratory information management systems, analytical equipment-attached software, enterprise resource planning tools, electronic batch and production records, electronic complaint handling, supplier-management systems, controlled spreadsheets, electronic-signature tools and AI-enabled/integrated software are now commonplace in regulated operations. 21 CFR Part 11 establishes controls for applicable electronic record keeping and electronic signatures, and under FDA’s current guidance, it generally applies when records required by an FDA statute are maintained electronically in lieu of paper, when companies rely on electronic records to perform regulated activities, when designated records are submitted electronically to FDA, or when electronic signatures replace required handwritten signatures. Not every computer system or electronic record is automatically subject to Part 11, and such determination can be made quickly in an Electronic System Gap Assessment.

Validation decisions and scope should be based on a justified, documented assessment of intended use, inclusive of product quality and safety, regulatory obligations, and the accuracy, integrity, availability and authenticity of required records and signatures. REJIMUS does not presume that every use of artificial intelligence is subject to Part 11, therefore, AI utilization is evaluated case by case as part of the underlying computerized system and regulated workflows. The assessment from REJIMUS considers whether AI creates, modifies, summarizes, classifies, recommends, reviews, approves, retains or transmits information that the company relies upon as a required record or to perform a regulated quality or compliance activity.

While most established Part 11 Validation service providers in the US, publicly center their costly services on companies in the pharmaceutical, biotechnology, and medical-device sectors, REJIMUS offers a notably more efficient and cost-effective alternative for consumer-product businesses in the foods, dietary supplements, cosmetics and OTC drugs sectors that are subject to the same regulations.

“Food, supplement, cosmetic and OTC companies are adopting cloud systems and AI at the same speed as the rest of the market, but many do not have software validation expertise in-house or know it is required,” said Brandon M. Griffin, CEO of REJIMUS, Inc. “AI can help quality and regulatory teams work faster, but speed cannot replace evidence, governance and accountability,” Griffin said. “Our role is to determine where the gaps are quickly, where AI sits in the regulated process, what controls and testing are proportionate to the risk, and how human oversight, vendor monitoring and change control can keep the system operating as intended.”

REJIMUS combines specialized Part 11 validation leadership with quality and regulated-operations expertise to address cGMP Quality Systems wholistically with an efficient compliance mindset. This is inclusive of SOP development, facility and supplier auditing, FDA inspection preparation, and most notably in the complete resolution and close out of of FDA Form 483’s and Warning Letters. That distinction matters because AI-enabled functions can and are introducing new risks that are different from conventional deterministic software. A human reviewer does not eliminate the need to understand and control the system when its output materially supports a regulated decision.

Services are scaled to the system, intended use and risk and may include:

Part 11 gap assessments; system, data-integrity and AI-use risk assessments; validation planning; and remediation roadmapsPart 11 auditing; user and functional requirements; supplier assessments; configuration, security, access-control, audit-trail and electronic-signature reviewsPart 11 validations; writing and executing of test protocols and scripts; IQ, OQ, PQ and user-acceptance testing, as applicable, inclusive of requirements traceability, deviations and Part 11 validation summary reportsExisting-system remediation; for data-migration validation, governing SOPs, staff training and change control, full and partial re-validations and ongoing lifecycle support

Part 11 Software Validation services from REJIMUS are available for new implementations, existing or legacy platforms, cloud and software-as-a-service systems, significant software upgrades, integrations, data migrations, inspection readiness and remediation following audit or FDA inspections. Learn more or request an assessment: www.rejimus.com/software-validation/

Media Contact

Brandon Griffin, REJIMUS, Inc., 1 6822671203, info@rejimus.com, www.rejimus.com

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SOURCE REJIMUS, Inc.

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From Pasture to Power: Gordon Solar Farm Showcases the Future of Farming and Solar Energy in New Zealand

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WHAKATĀNE, New Zealand, Nov. 10, 2026 /PRNewswire/ — An agrivoltaic project in Galatea, New Zealand, is demonstrating how agricultural land can generate renewable energy while continuing to support productive farming, offering a new approach to land use for rural communities.

The Gordon Cattle and Solar Farm, located in the Whakatāne District, combines a 4.7 MW solar installation on 8 hectares of land with a dairy farm operation of around 700 cattle heads. Featuring TCL Solar 625W TOPCon modules and Clenergy ezTrackers D1P, the project brings together solar technology, agricultural expertise and tracking infrastructure to demonstrate the potential of dual-purpose land use.

The official opening of the project will take place on Thursday, 12 November 2026, at the Gordon Dairy Farm in Galatea. The public event will bring together representatives from the agricultural and renewable energy industries, project partners and local communities, with a live panel discussion exploring the opportunities and practical considerations of integrating solar generation into working farmland.

Making More of Agricultural Land

Agrivoltaics refers to the integration of solar energy generation and agricultural activities on the same land. At the Gordon Solar Farm, solar trackers are elevated to 2.2 metres, allowing cattle to continue grazing beneath the installation. During daylight hours, the tracking system follows the sun to optimise electricity generation, while the farm retains its agricultural function.

This approach offers potential benefits beyond electricity production. By providing shade, the solar installation reduces direct sun exposure to the ground, lowering soil temperatures and moisture loss, and diminishing irrigation requirements. For livestock, shaded areas can offer relief from intense heat and contribute to improved animal comfort during warmer conditions.

The relationship can also benefit the solar installation itself. Vegetation and moisture beneath the panels may help moderate the module temperature and support energy generation.

Solar Technology Designed for Agricultural Environments

Operating solar modules in an agricultural setting presents specific technical challenges. One consideration is exposure to ammonia, a corrosive gas released through livestock waste, manure and agricultural processes. Over time, ammonia can affect susceptible materials and components within solar modules, potentially contributing to corrosion and reduced long-term performance.

This makes module durability an important consideration when selecting solar technology. The TCL Solar TOPCon modules supplied for the Gordon project have undergone ammonia corrosion resistance testing in accordance with IEC 62716, the international standard for assessing resistance to ammonia exposure.

The enhanced certification provides an additional layer of validation and reflects the importance of selecting technology suited to the specific environment of a project.

Bringing Farming and Solar Expertise Together

The Gordon Solar Farm has been delivered through collaboration between the Gordon family, TCL Solar, Clenergy, Micropico, insurance and financial partners. Each partner brings a different perspective to the project, from the practical realities of operating a working dairy farm to the engineering and technology required to integrate solar generation into an agricultural environment.

These perspectives will come together at the official opening during a live panel discussion that will explore the lessons emerging from the project and consider a broader question for the agricultural and energy sectors: how can landowners create additional value from their land while continuing to support the farming businesses and communities that depend on it?

A Model for the Future of Rural Renewable Energy

For TCL Solar, the project demonstrates the importance of reliable module technology in installations with specific operational and environmental demands.

As New Zealand continues to expand its renewable energy capacity, the Gordon Solar Farm offers a practical example of how solar energy can become part of the wider agricultural landscape, creating opportunities for farmers, energy providers and rural communities alike.

The official opening of the Gordon Cattle and Solar Farm will take place on Thursday, 12 November 2026, at 228 Grant Road, Galatea, New Zealand.

For more information, visit www.tclsolar.com

About TCL Solar

TCL Solar is one of TCL Zhonghuan’s two flagship module brands, alongside SunPower for the Australian and Pacific markets.

TCL Zhonghuan (TCL Zhonghuan Renewable Energy Technology Co., Ltd.) is a BNEF Tier 1 global solar manufacturer and a technology leader across the photovoltaic value chain. Founded in 1958, the company has played a defining role in the development of the global PV industry, beginning monocrystalline silicon R&D in 1969. With full vertical integration from ingots and wafers through to modules, TCL Zhonghuan became the world’s #1 silicon wafer manufacturer in 2024, achieving 19% of global production capacity share. Ongoing innovation is supported by over 4,600 solar-specific patents, alongside advanced manufacturing capabilities. The acquisition of SunPower in 2025 and DAS Solar in 2026 further strengthens TCL Zhonghuan’s position in high-efficiency BC technology.

View original content:https://www.prnewswire.com/apac/news-releases/from-pasture-to-power-gordon-solar-farm-showcases-the-future-of-farming-and-solar-energy-in-new-zealand-302934622.html

SOURCE TCL Solar

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GTN appoints former Gemini and Kraken executive Mark Jennings as global head of digital assets

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New role to lead GTN’s tokenisation strategy as more platforms bring traditional assets on-chain

DUBAI, UAE, Nov. 10, 2026 /PRNewswire/ — GTN, the global fintech powering limitless investment, today announced the appointment of Mark Jennings as global head of digital assets. Mark will lead GTN’s strategy to support tokenised securities through its global market access.

Mark joins GTN from Gemini, where, as CEO of Gemini Europe, he led the exchange’s European expansion. Before that, he held senior roles at Kraken, including CEO of Crypto Facilities, its FCA-regulated derivatives venue for institutional clients.

Manjula Jayasinghe, GTN’s co-founder and group CEO, said: ‘We are seeing growing demand for tokenised securities, where investors can trade traditional assets on-chain, 24/7, with real-time settlement, and we expect this trend to accelerate in the years ahead. With our industry-leading multi-market, multi-asset coverage, we are well positioned to help platforms bridge traditional and digital markets. Mark brings substantial experience from the digital assets industry and will lead our efforts with the right technology, partnerships and regulatory approach.’

Mark said: ‘Tokenisation is one of the most significant shifts in market infrastructure in decades. At Gemini and Kraken, I saw first-hand users’ demand for traditional assets alongside crypto, and the complexity of delivering them in a robust, compliant and scalable way. GTN has already done the difficult work to connect to markets and asset classes. That puts us in a unique position to take a leading role in helping platforms bring those assets on-chain. I’m excited to lead that work with platforms across the ecosystem to bring tokenised securities to their users.’

Mark’s appointment follows GTN’s hire of former Saxo Bank executive Daniel Endler as its first group chief product officer in October. Together, the two appointments strengthen GTN’s senior leadership as it expands its offering for financial institutions and digital asset platforms.

About GTN
GTN is the global fintech infrastructure powering limitless investment through a unified API-first architecture. By combining cloud-native technology with deep institutional expertise, GTN provides brokers, banks, asset managers and fintechs with brokerage infrastructure spanning 90+ markets and up to 8 asset classes across GTN’s six regulated entities, through a single API, enabling partners to create the next generation of investing and trading experiences. From fractional trading and micro-portfolios, including $1 fractional bonds, to full-service brokerage, GTN automates the investment lifecycle from digital onboarding to post-trade settlement. As a single counterparty, GTN reduces technical and regulatory burdens, enabling investment banks, brokerage firms and wealth management firms to scale without having to build technology from scratch.

GTN has over 700 professionals across 14 countries and serves more than 500 clients worldwide, united by one mission: transforming the accessibility of investment and trading opportunities. GTN operates through six regulated entities, each authorised in its own jurisdiction: FCA in the UK, DFSA in the DIFC, MAS in Singapore, SEC and FINRA in the US, FSCA in South Africa and SFC in Hong Kong. Strategic investors include IFC (World Bank Group) and SBI Ventures Singapore. To learn more, visit www.gtngroup.com or follow us on LinkedIn.

View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/gtn-appoints-former-gemini-and-kraken-executive-mark-jennings-as-global-head-of-digital-assets-302933671.html

SOURCE GTN

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AI Plans Outrun Store Realities as Bad Stock Data Can Cost Large Retailers Millions Each Year

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Scandit survey of store associates finds stock records match shelves less than half the time, fueling a ‘shadow store’ of paper, chats and photos that leaves AI working from an incomplete view of the store and business

ZÜRICH, Nov. 10, 2026 /PRNewswire/ — Scandit, the leader in smart data capture powered by vision AI, today released the results of global research revealing that retail’s race to deploy AI is running ahead of the data reality inside its stores. Store associates reported that stock information matches what they find on the shelf just 46% of the time while only 8% trust store data completely. This creates a costly gap between what the system says, what is actually in the store and what customers experience, while leaving AI and other technology investments to act on incomplete records.

That gap is already being absorbed by labor. Associates estimate they would each get back more than 4.4 hours a week, nearly six working weeks a year, if they had data they could trust. That time amounts to millions in recoverable labor hours. A retailer employing 10,000 store associates, for example, faces more than $41 million a year* in labor cost tied to compensating for the gap. Extrapolating that time across the entire pool of retail associates in the U.S., as tabulated by the U.S. Bureau of Labor Statistics, inaccurate data could cost the retail industry as much as $22 billion annually.

And when the system is wrong, associates do what they have to do to keep the store running. Nearly half (49%) correct the record themselves and 44% raise a stock adjustment. But among associates who take action, 42% bypass the official system entirely, while 68% use at least one informal method, including paper notes, team chats, personal phone photos and apps or memory. The result is a ‘shadow store’ in which vital information exists outside the record that head office, dashboards and AI systems rely on.

“Retailers do not have an AI adoption problem as much as a store truth problem,” said Samuel Mueller, CEO and co-founder of Scandit. “Associates are spending valuable time repairing these gaps, yet much of that work disappears into unofficial tracking systems. Before retailers ask AI to make more decisions based on inaccurate store data, they need a shared, accurate view of what is actually happening on the shelf and across their stores.”

Associates’ trust in stock data does not build gradually. The survey highlights it stays low until the data is very good. Only 8% of associates completely trust their store’s stock information, and only one in four say it is accurate more than 70% of the time. Among associates who put accuracy anywhere up to 50%, roughly a quarter report high trust, and that figure barely moves until accuracy passes 70%, when it rises sharply.

“This is not a gradual improvement problem,” said Andrew Smith, Managing Partner and co-founder of ThinkUncommon and a RETHINK Retail Top Expert since 2021. “Moving stock accuracy from 46% to 60% may look like progress in a board report and still change nothing on the floor. Trust only begins to move once accuracy clears 70%, and until then associates do what sensible people do: they check the shelf themselves and either correct the system or just do what they need to do to help the customer in front of them.”

The consequences extend beyond productivity. Associates report spending an average of 4.1 hours each week handling customer questions that store technology should be able to answer, and are asked to physically check whether an item is in stock 5.85 times a week on average. More than one in five say they make those checks more than ten times a week.

The findings point to a practical lesson for technology deployment: associates who participated in a pilot reported using most store tools at a rate of 74%, compared with 61% among those who were consulted before rollout and those who were never asked. Half of pilot participants reported high trust in their stock data, compared with 25% of those who were never asked for input.

Read The Store Truth Gap report here.

Asked what would make inventory management workflows easier, associates said responded with the following:

“Get the stock counts actually right so I’m not chasing ghost inventory.””A lot of times the back stock isn’t in the system so I go and have to physically check more often than I’d like.””More accurate layouts. Sometimes it sends me to a location that doesn’t have product.””More consultation from head office with us, who are the ones facing the customer.”

*Estimate is based on an average self-reported $18 hourly wage

About the survey

Scandit commissioned Sapio Research to survey 2,200 store associates online in September 2026. All worked in physical stores for retailers with more than 1,000 employees across the U.S., Germany, UK, France, Italy, Canada and Poland. The research covered grocery, mass merchant and department store, hypermarket and supercenter, DIY and home improvement, convenience, and drugstore and pharmacy formats.

About Scandit

Scandit is the leader in smart data capture, powered by vision AI, giving superpowers to workers, customers, and businesses by providing actionable insights and automating end-to-end processes. Its Smart Data Capture platform enables smart devices, such as smartphones, handheld computers, drones, digital eyewear, robots, and fixed cameras to interact with physical items by capturing data from barcodes, text, IDs, and objects with unmatched speed, accuracy, and intelligence.

Scandit enables innovation that delivers significant cost savings, increases employee retention and customer loyalty. The company partners with customers at every step with trials, solution design, integration, and customer success support included.

Visit scandit.com to learn why market leaders across retail, transport and logistics, healthcare and manufacturing like Instacart, Carrefour, Ahold Delhaize, Albertsons, Levi Strauss & Co., Sephora, Lufthansa, and FedEx trust Scandit.

 

 

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/ai-plans-outrun-store-realities-as-bad-stock-data-can-cost-large-retailers-millions-each-year-302934596.html

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