Chemical & Pharma AI Agents with Live LIMS & SAP QM Sync..

Our pharma AI agents parse long documents. They read executed batch records. They check equipment logbooks. They review release testing certificates. The agent cross-checks temperature logs. It verifies mixing durations. It confirms raw material lot numbers. It tests yield tolerances against the Master Batch Record. It flags deviations. It marks out-of-specification events. Each finding includes exact timestamps and page citations.

Yes. The agent correlates batch release data. It checks environmental monitoring logs. It reviews supplier raw material CoAs. It inspects equipment calibration logs. It drafts structured CAPA outlines. Findings include verifiable source citations. Quality engineers review each draft. The agent speeds up root-cause research. It preserves required human sign-off.

Every ingestion step records in audit logs. These logs use tamper-evident hashes. The pipeline strictly follows GxP rules. It complies with FDA GMP guidelines. It enforces ALCOA+ principles. Every record remains attributable and legible. Entries stay contemporaneous and original. They remain accurate and complete. Records stay consistent and enduring. Inspectors can review any decision on demand.

Yes. The agent extracts chemical assay percentages. It measures moisture content. It verifies impurity limits. It tracks microbial thresholds. Data comes from supplier PDF CoAs. It compares values against acceptance rules. Out-of-spec shipments flag immediately. It cites the exact CoA line. Quality teams receive immediate alerts. It never releases inventory automatically.

Yes. Quality teams set parameter ranges first. The agent pre-screens executed batch records. It routes genuine exceptions to human reviewers. It flags out-of-trend values. Missing signatures alert supervisors. Compliant batches move to summary queues. Qualified Persons review summaries quickly. This cuts review time significantly.

Yes. The agent ingests stability chamber data. It checks long-term conditions. It monitors intermediate conditions. It tracks accelerated study points. It plots degradation trends against limits. Out-of-trend values trigger early warnings. This avoids out-of-specification failures. Teams receive early warnings on shelf-life. Data exports into annual stability reports.

The agent inspects product formulas. It checks CAS numbers. It reads concentration levels. It reviews raw material hazard classes. It calculates water toxicity. It checks flash points. It finds acute toxicity limits. Data fills all 16 GHS sections. Output adds pictograms and warning text. It lists safety gear rules.

Yes. Chemical regulations update frequently. Rules change across EPA TSCA lists. California Proposition 65 lists update too. EU REACH Annex XVII changes regularly. The agent scans chemical inventories. It identifies affected product SKUs. It recalculates hazard classes. It drafts updated revisions with changelogs.

The agent queries property data. It checks solubility numbers. It reviews Hansen coordinates. It checks viscosity and costs. Supply gaps disrupt plants. The agent finds substitute surfactants. It suggests replacement polymers. Swaps match performance specs. Recipes protect profit margins. Chemists review and approve swaps quickly.

Yes. The agent generates 16-section SDS documents. It authors files in English and Spanish. It supports French and German. It writes in Japanese and Mandarin. Regional exposure limits update accurately. These include OSHA PEL and ACGIH TLV. They include REACH DNEL limits. Mandated emergency hotlines attach automatically. All language versions stay in sync.

Suppliers sometimes change formulas. Downstream SDS files then require updates. The agent finds all affected blends. It flags CAS concentration shifts. It recalculates hazard classifications. It drafts revised 16-section SDS files. It updates document repositories. This prevents non-compliant shipments.

Yes. We engineer tamper-evident audit logs. Every user action generates a timestamped record. Cryptographic hashing secures every event. Changes require dual-factor electronic signatures. Audit trails meet ALCOA+ guidelines. They stand up to FDA inspections. Validation packets include full IQ, OQ, and PQ records.

Yes. The agent aggregates analytical validation summaries. It compiles stability testing time-points. It tracks container closure integrity data. It formats manufacturing flowcharts. It builds structured eCTD Module 3 outlines. These support IND and NDA submissions. Specialists write the final narrative. The agent removes days of data gathering.

The agent gathers 12 months of batch data. It tabulates statistical Cpk and Ppk metrics. It charts yield variability across lots. It synthesizes customer complaint trends. Output formats into APQR regulatory filings. Quality teams avoid weeks of spreadsheet work. Reviewers check structured drafts in days.

Yes. The agent reviews clean-in-place records. It evaluates toxicological HBEL limits. It checks PDE calculations. It reviews swab test assay results. Shared equipment runs exceeding thresholds flag immediately. This protects multi-product manufacturing plants. Shared drug lines verify cleaning data first. No new batch starts without verification.

Yes. Customers often request regulatory declarations. Examples include REACH SVHC statements. Another is California Proposition 65 documentation. The agent checks current ECHA lists. It checks OEHHA candidate lists against CAS numbers. It drafts signed compliance letters in minutes. Regulatory specialists save days of research.

We build native bi-directional connectors. We connect LabWare LIMS and SampleManager. We integrate Waters CDS chromatography tools. We sync SAP S/4HANA QM and PP modules. We support Oracle NetSuite and Veeva Vault. We also support Infor and Epicor. Microsoft Dynamics 365 connects via APIs. Middleware like Mulesoft or Boomi works too.

Yes. The platform supports corporate single sign-on. It connects via SAML or OAuth. Staff use existing corporate accounts. No separate passwords are required. Role-based access control enforces strict permissions. Admins revoke access centrally upon role changes.

We deploy isolated private VPC architectures. We support on-premise air-gapped GPU servers. All setups use Zero Data Retention agreements. Chemical formulas never train public models. Synthesis routes remain confidential. Legal teams can audit infrastructure directly. We run regular penetration tests. We sign mutual NDAs and GxP agreements.

Your organization owns 100 percent of source code. You own the Git repositories. You own Python backend services. You own prompt state machines and Docker files. We charge zero per-user licensing fees. Handover includes deployment guides and credentials. The system runs under your control indefinitely.

Focused SDS authoring engines deploy in 4 to 6 weeks. CoA extraction pipelines follow that timeline. Enterprise GxP systems deploy in 8 to 12 weeks. That includes LIMS setup. It includes IQ, OQ, and PQ records. Timelines depend on connected systems. Historical batch data guides the schedule.

Yes. Audit logs store independently of vendor systems. Cryptographic hashes protect each record. Timestamps stay verifiable after migrations. Batch records remain complete and attributable. Files remain available for FDA and EMA inspectors. Data never traps in legacy software.