Bound by confidentiality
Not left behind on AI
Specialists in pharma, research, legal, and industrial engineering spend hours checking dossiers against guidelines, updating SOPs, and comparing specification versions. Omnifact gives your teams an AI assistant grounded in your approved documentation, with automatic personal data pseudonymization via the Privacy Filter, project-level isolation, and hosting in Germany.
Which requirements of the EMA process validation guideline does report VR-114 not yet address?
Report VR-114 does not yet address the following requirements of the EMA guideline on process validation.
- A justification for the number of validation batches
- A plan for ongoing process verification after approval
All other required elements, including the critical process parameters, are covered in the report.
EMA Process Validation Guideline.pdfAlready in use in regulated industries
Built for
regulated industries
Protect professional secrecy and proprietary know-how, back every answer with verifiable document citations, and give legal and compliance teams clear technical safeguards.
Privacy Filter™
Rule-based and AI-powered detection pseudonymizes names, identifiers, and contact details before a model processes them. Confidential client and project references remain inside your organization.
Privacy Filter™JMJulia MeyerSummarize the deviation reported by Dr. Anna Koch and draft a reply to the sponsor contact Michael Brandt at m.brandt@example.com.
Answers from your own documents
Bring validation guidelines, technical specifications, and SOP templates into dedicated Spaces. Every answer links directly to the underlying document and passage.
Personal onboarding
Individual onboarding, use-case workshops and product training for your teams.
- Kickoff call
- Admin setup
- Use-case workshop
- Product training
Single sign-on
Staff sign in with your existing identity provider, and groups can be synced automatically.
Entra IDOktaSign in with SSOKeycloakSAML 2.0
From the first draft
to the final sign-off
Cut the manual comparison work in regulatory, quality, and research teams: draft SOPs from your own templates, check reports against EMA or ISO standards, and compare specification revisions with source citations.
Draft an SOP for cleaning the tablet press, following our SOP template and GMP requirements.
SOP: Cleaning the tablet press
Purpose and scope: This SOP describes the cleaning of the tablet press after each batch and after product changeovers. It applies to all production staff in building 2.
Procedure: Dismantle the punches and dies, clean them with the approved detergent, and document each step in the cleaning log. Quality assurance releases the press after visual inspection.
Strict project isolation
Need-to-know by design
Keep client mandates, research programs, and departments separated by permission boundaries. Admins control which AI models and hosting regions each group can access.
Isolated Spaces per project or mandate
Assign each project or client team its own Spaces and groups, so only authorized specialists can search those documents.
EU-hosted models with Zero Data Retention
Limit groups to EU-hosted models from OpenAI, Anthropic, Mistral, or Google under contractual Zero Data Retention. Prompts and files are never used for model training.
Secrecy under § 203 StGB and German hosting
Omnifact runs as an ISO 27001-certified SaaS in Germany and includes a confidentiality agreement under Section 203 StGB alongside private cloud and on-premises options.
- ABAnna Beckera.becker@musterpharma.de
- JWJonas Weberj.weber@musterpharma.de
- LDLeyla Demirl.demir@musterpharma.de
- TSThomas Schulzt.schulz@musterpharma.de
- MHMarie Hoffmannm.hoffmann@musterpharma.de
- DKDaniel Krügerd.krueger@musterpharma.de
- SWSophie Wagners.wagner@musterpharma.de
- LNLukas Neumannl.neumann@musterpharma.de
- FYFatma Yılmazf.yilmaz@musterpharma.de
- Upload Files & AttachmentsAttach documents and other files to chats and Spaces.Revoke
- Use Web Search and BrowsingSearch the web and access live information.Revoke
- Generate ImagesUse AI image generation to create visuals.Grant
- Use Premium ModelsUnlocks frontier and expensive models.Revoke
- Enable US-Hosted Models AccessData residencyRoutes model requests to US-region infrastructure.Grant
Frequently asked questions
clear answers for regulated industries
What quality assurance, legal counsel, compliance, and IT security leads ask before introducing Omnifact.
Which regulated organizations use Omnifact in daily work?
Omnifact is built for organizations bound by confidentiality and regulatory oversight beyond the GDPR: pharmaceutical, biotech, and medical device companies, contract research organizations (CROs), research institutes, defense and industrial suppliers, and law, tax, and audit firms. Teams use Omnifact to check dossiers against regulatory guidelines, draft SOPs, compare technical revisions, and search internal archives.
How does Omnifact fit into GxP quality review and regulatory sign-off?
Omnifact prepares drafts, document comparisons, and gap analyses with a direct citation to the source passage for every claim. Qualified staff review the output and remain responsible for formal verification and regulatory sign-off, so your existing four-eyes and quality release processes stay intact.
How does Omnifact protect confidential project and client data?
Omnifact is operated as an ISO 27001-certified SaaS in Germany. The integrated Privacy Filter uses rule-based and AI-powered detection to pseudonymize personal data in chat prompts before an external model processes them. Contractual Zero Data Retention with EU-hosted models ensures that inputs and outputs are never stored by model providers or used for model training.
Does Omnifact offer a professional secrecy agreement under § 203 StGB?
Yes. For organizations bound by statutory professional secrecy under Section 203 of the German Criminal Code (§ 203 StGB), such as law firms, tax advisors, auditors, and medical organizations, Omnifact provides a supplementary confidentiality agreement alongside the Art. 28 GDPR data processing agreement.
How do you keep client mandates and research projects separated in Omnifact?
Knowledge in Omnifact is organized into isolated Spaces with role-based access control. Admins assign Spaces to specific user groups synced from your identity provider via SSO. Specialists assigned to Project A can only search and reference documents inside Spaces authorized for Project A.
Which deployment options does Omnifact support for high-security environments?
Most regulated organizations run Omnifact as an ISO 27001-certified SaaS hosted in Germany, combined with EU-only model routing, Zero Data Retention, and the Privacy Filter. For organizations with stricter infrastructure or export-control requirements, dedicated private cloud and on-premises deployments are also available.
See how Omnifact fits your compliance standards
Walk through a realistic regulatory or research workflow with our team. Bring a sample guideline, SOP template, or dossier requirement and see how Spaces and the Privacy Filter work in practice.