Alera - Regulated collaboration for the AI era
Validated AI platform and virtual consultants for regulated industries
Systematic and accountable AI adoption for regulated industries built on role-based agents, curated knowledge, and full transparency.
AI adoption is accelerating, but most AI usage remains fragmented. Many teams rely on ad-hoc tools or standard copilots that do not scale across workflows, create vendor lock-in, and lack the control required for regulated processes and projects.
For organization in regulated industries this becomes a barrier. Without clear governance, traceability, and accountability, AI cannot be embedded into critical processes or trusted across teams.
Alera is NNIT’s validated AI platform for systematic and repeatable AI usage. It connects to your data, roles, and workflows, enabling teams to work with role-based AI agents grounded in curated knowledge and trusted LLMs, all within a secure chat interface.
Beyond conversation, AI agents can support and automate regulated tasks and workflows, while keeping responsibility and oversight with the people in charge. Alera can be deployed in any cloud or on-premises, integrated with systems like RIMS, QMS, MES, and ERP, and operated with the transparency required to comply with data privacy and industry regulations.
Collaborate across your organization
Alera connects to your data sources, roles and workflows, providing users with role-based access to relevant data in a secure context.
Transparency at the center
Designed for auditability, observability and validation, Alera supports regulated requirements for traceability and control.
From chat to automated processes
Alera is more than a chat interface. AI agents can be configured to support and, in many cases, automate regulated workflows and tasks.
Designed for roles and responsibilities in regulated industries
Alera is designed around AI‑native NNIT consultants who are trained to work with AI as part of their professional role, not as an afterthought. In practice, this means higher right‑first‑time delivery, fewer review cycles, and stronger traceability across regulated deliverables.
When NNIT starts a new project, consultants work in clearly defined roles, such as project management, validation, development, and testing, supported by role‑based AI agents grounded in approved, project‑specific knowledge. Consultants orchestrate the work, apply judgment, and remain accountable for compliance and outcomes, while AI support improves consistency, reduces rework, and accelerates time to first draft without compromising regulatory control.
Alera features
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Virtual consultants for any role
Alera enables role-based AI agents that support project work such as planning, validation documentation, and testing.
Each virtual consultant works from curated knowledge and proven patterns, supporting human teams with full review and accountability.
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Secure AI with data sovereignty
Alera is designed so your data stays under your control and is used only for the intended purpose.
This supports secure deployments and strong governance in regulated settings.
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Integrate Alera into your own infrastructure
If you want, NNIT can implement Alera into your infrastructure, connect it to your data and systems, and support the organizational change needed to maximize the benefits.
Business process automation with multiple AI agents
Alera can automate a wide variety of processes in regulated industries through a chain of agents. Each process is carefully mapped, and AI agents are orchestrated to perform specific, contained tasks such as comparing data, identifying discrepancies, suggesting resolutions, translating, and escalating to humans when needed.
Here are examples of business processes Alera can support.
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Global/local documentation harmonization
Alera supports the alignment of global master documents with local regulatory or market-specific versions.
It identifies differences, manages traceability, and ensures local adaptations remain consistent with approved global content.
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Drug safety support for pharmacists
Alera analyzes drug databases, patient records, and literature to detect potential drug–drug interactions and adverse effects.
This helps pharmacists assess risk more quickly and supports safer medication decisions.
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Patient recruitment for clinical trials
Alera screens structured and unstructured patient data against trial inclusion and exclusion criteria.
This improves identification of eligible patients, accelerates recruitment, and reduces manual review effort.
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MES upgrades and migrations
Alera assists with manufacturing execution system (MES) upgrades by analyzing legacy configurations, data flows, and Master Data configurations.
It automates complex technical data activities that would typically take months of efforts.
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Improved training (Read and Understand Plus)
Transform existing materials into structured learning content like summaries, quizzes, and role-specific training.
This improves training outcomes and ensures that the staff doing the training are more engaged and motivated.
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R&D data standardization
Alera harmonizes heterogeneous R&D data from multiple sources into common standards and formats.
This improves data quality, interoperability, and downstream analytics across research programs. Specifically, CMC data and support for FHIR.
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Pre-clinical molecule discovery support
Alera analyzes biological, chemical, and experimental data to identify and prioritize promising molecular candidates.
This supports target identification, lead optimization, and reduces time and cost in early drug discovery.
Technical capabilities for the Alera platform
Alera is designed to run in your preferred environment and meet enterprise requirements, with vendor flexibility and data sovereignty built in. We provide continuous updates and improvements, new features and fixes.
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Cloud agnostic and on-prem capable
Deploy in your preferred environment and align with your security, residency, and IT strategy.
Native support for cloud storage backends including Amazon S3 (with S3-compatible providers), Google Cloud Storage, and Microsoft Azure Blob Storage for scalable file storage and data management.
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Model and API flexibility
Integrate with any OpenAI Chat Completions–compatible endpoint, including OpenAI, third-party, and local providers. Configure the base URL to fit your infrastructure.
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Identity and access management
Granular roles, user groups, and permissions across the workspace, plus SCIM 2.0 provisioning for automated user lifecycle management (e.g., Okta, Azure AD, Google Workspace).
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Knowledge grounding (RAG) and vector database support
Built-in Retrieval Augmented Generation (RAG) with support for multiple vector databases to ground responses in approved sources.
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Document ingestion and extraction
Extract text and structured data from common formats (PDF, Word, Excel, PowerPoint, and more) using configurable extraction engines.
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Multi-model and research workflows
Use multiple models in parallel and enable web search for RAG and agentic research across 15+ providers.
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Cross-device capabilities – voice and mobile
Responsive UI across desktop and mobile, with Progressive Web App (PWA) support for a native-like mobile experience.
