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.
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 roadmaps
- Part 11 auditing; user and functional requirements; supplier assessments; configuration, security, access-control, audit-trail and electronic-signature reviews
- Part 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 reports
- Existing-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, [email protected], www.rejimus.com
SOURCE REJIMUS, Inc.
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