Batch records that guide the run.
Seal captures the batch as it runs. AI-configured workflows evolve with your process. Unified with LIMS, QMS, and ELN.
Every blueprint is the same platform, configured: controlled records, review, change control, training, audit evidence. Not modules to buy. Starting points neil tailors to your process.
Seal captures the batch as it runs. AI-configured workflows evolve with your process. Unified with LIMS, QMS, and ELN.
Every quality event arrives with full context. AI-configured workflows evolve with your process. Unified with MES, LIMS, and ELN.
Seal checks results against live specs. AI-configured methods evolve with your process. Unified with MES, QMS, and ELN.
Seal turns experiments into structured evidence. AI-configured methods evolve with your process. Unified with LIMS, MES, and QMS.
Control every material definition, lot, container, quantity, location, status, expiry, storage exposure, reservation, movement, dispense, use, reconciliation, and disposition—from receipt to batch genealogy.
EDC, CTMS, and eTMF share one data model. Sites enter data once. Documents file themselves. Queries resolve in context.
Asset identity, hierarchy, intended use, criticality, qualification, calibration, cleaning, status, usage, logbooks, configuration, maintenance coordination, operator eligibility, impact assessment, change, and retirement.
Controlled authoring, review, approval, effective dates, distribution, training impact, periodic review, forms, external documents, archival, and point-of-use access for GxP records.
Study, country and site planning; feasibility; startup; activation; enrollment; monitoring; issues; payments; vendors; milestones; closeout; and sponsor oversight connected to EDC, eTMF, safety, and quality.
Products, registrations, dossiers, submissions, health-authority correspondence, commitments, labeling, regulatory intelligence, and market-specific change assessments in one global regulatory record.
For sponsors and CDMOs alike: recipe-driven development, one-click tech transfer, MSAT continuity, and CMC submissions rendered from the live spine. The line, the master batch record, and Module 3 say the same thing because they're views of the same object.
Role curricula, document-triggered training, practical assessment, qualification, requalification, equivalency, trainer authorization, effectiveness, and work authorization in one GxP learning record.
Maintenance requests, criticality, preventive and meter-based plans, work permits, lockout, work orders, parts, contractors, calibration coordination, breakdowns, production impact, return to service, reliability, and recurring-failure improvement.
GMP receiving, quarantine, put-away, status and location control, sampling moves, FEFO allocation, picking, kitting, dispensing handoff, cold chain, cycle count, shipping, returns, and recall traceability.
Plan and manage trial-master-file content using governed reference models and study-specific expectations; ingest, classify, QC, approve and file artifacts; track completeness, timeliness and quality by study, country and site; manage correspondence, access, inspection packages, transfer, reconciliation, and long-term archive.
Design and validate clinical studies, eCRFs and edit checks; manage subjects, visits and site entry; ingest external data; run medical and data review; govern queries, coding and reconciliation; track cleaning; freeze and lock the database; and deliver traceable analysis-ready datasets.
Automatically capture scientific instrument and application data, preserve original files and metadata, prove file-set completeness and integrity, connect data to samples and work, govern review and derived versions, search across formats, retain and restore records, and manage migrations and legal holds.
Plan collections, create labels and containers, maintain chain of custody, model rooms and storage positions, manage aliquoting, pooling and derivatives, reserve and request samples, pick and ship with verification, track tests and consumption, monitor excursions, reconcile discrepancies, and govern retention and disposition.
Seal transfers the process as data. AI-configured workflows evolve with your process. Unified with MES, QMS, and ELN.
Author, execute, review, and release GMP batch records with material and equipment checks, automated data capture, controlled exceptions, and complete history.
Product and process targets, unit operations, materials, experiments, parameters, scale models, yields, samples, quality attributes, knowledge claims, process candidates, maturity gates, and transfer readiness connected across ELN, LIMS, equipment, characterization, and tech transfer.
Safety intake, minimum criteria, triage, duplicate search, follow-up, MedDRA and product coding, seriousness, expectedness, causality, case quality, jurisdiction-aware timelines, ICSR generation and acknowledgements, aggregate reporting, signals, benefit-risk, and safety-quality linkage.
Controlled report definitions, governed metrics, frozen data cuts, traceable tables and narratives, review, approval, scheduling, distribution, and live quality intelligence across GxP operations.
Risk-based viable, nonviable, surface, personnel and utility monitoring with governed locations, schedules, production context, chain of custody, incubation, counts, identification, limits, trend rules, excursions, investigations, product impact, and program review.
Execute the device master record with component genealogy, in-process inspection, UDI and labels, sterilization, nonconformance, and release attached to every lot or serial number.
Manage supplier, manufacturer and site identities; risk and material or service scope; qualification plans, questionnaires and audits; quality agreements; approved-supplier states; incoming lot and CoA performance; deviations, complaints and SCARs; supplier changes; scorecards, monitoring, requalification, restrictions, and disqualification.
Plan batch-release evidence from the approved product state, review execution and testing concurrently, resolve exceptions, control market eligibility, generate CoAs, and sign an accountable disposition.
Protocol demand, kit and label design, packaging, randomization identifiers, depot and site inventory, temperature, returns, and reconciliation.
Connect product and equipment matrices, residue limits, worst-case rationale, cleaning instructions, swab and rinse samples, deviations, and continued verification.
Replace paper equipment, area, utility, and shift logs with structured GMP entries, live status, task handoffs, exception workflows, and traceable review.
Run laboratory assessment, hypothesis testing, manufacturing investigation, batch impact, CAPA, trending, and disposition without losing the original result or scientific rationale.
Define the regulated record universe, schedule risk-based audit trail review, reconstruct changes in context, investigate anomalous activity, and prove that every GxP decision used complete and trustworthy evidence.
Plan and execute process performance qualification, govern readiness and acceptance criteria, connect manufacturing and laboratory evidence, resolve deviations, calculate capability, approve validation conclusions, and hand the proven process into continued verification.
Medical-device ISO 14971 risk files and pharmaceutical quality risk management with plans, hazard analyses, FMEAs, risk criteria, control options, verification, residual and overall risk, benefit-risk, production and post-production evidence, review, and change impact.
Run environmental monitoring, sterility, bioburden, endotoxin, utilities, growth promotion, incubation, organism identification, excursions, trending, and release.
Plan and execute facility, utility, equipment, automation, and computerized-system CQV from requirements and risk through turnover, testing, exceptions, release, and continued qualified state.
Design APS coverage across lines, shifts, operators, interventions, container configurations, campaign conditions, incubation, unit reconciliation, failures, and requalification.
Control material, in-process, release, and stability specifications across products, sites, markets, methods, sampling plans, lifecycle stages, changes, testing, and disposition.
Connect product definitions, processes, specifications, methods, characterization, validation, stability, claims, CTD sections, market variants, review, and post-approval change without rebuilding truth in documents.
Connect QMS changes, health-authority commitments, market assessments, submission dependencies, implementation controls, and closure evidence without turning the QMS into a second RIMS.
Continuously assemble batches, results, deviations, changes, stability, complaints, supplier evidence, process capability, conclusions, and follow-up actions.
Connect analytical target profiles, development knowledge, validation characteristics, transfer protocols, method versions, instruments, specifications, and routine monitoring.
Build and maintain a living CCS across facility, people, utilities, cleaning, sterilization, aseptic process, monitoring, investigations, trends, changes, and sterility assurance review.
Control packaging orders, line readiness, components and printed materials, coding, in-process checks, rejects, rework, label reconciliation, aggregation, yields, deviations, and packaged-batch release.
Operate PW, WFI, clean steam, process gas, vacuum, and other high-risk utilities with system topology, qualification, online monitoring, point-of-use sampling, sanitization, maintenance, trends, excursions, and product impact.
Monitor version-aware process parameters, material attributes, equipment, yields, holds, deviations, and quality attributes with governed populations, signals, and actions.
Control instrument ranges, procedures, reference standards, due work, as-found and as-left data, uncertainty, tolerances, out-of-tolerance impact, labels, and use eligibility.
Qualify standards and critical reagents, prepare controlled solutions, enforce container and open-life state, record exact analytical use, and find every result affected by a later material concern.
Make sponsor, CDMO, laboratory, supplier, packaging, storage, and distribution responsibilities executable across notifications, investigations, record exchange, release, escalation, performance, and review.
Manage moist and dry heat, depyrogenation, gas, radiation, and other sterilization processes with validated load patterns, item genealogy, cycle recipes, probes, indicators, physical records, exceptions, load release, and downstream impact.
Run health-hazard evaluation, affected-lot and unit scope, recall strategy, authority communication, consignee notification, response tracking, product reconciliation, effectiveness checks, status reporting, and termination.
Qualify routes and shipping systems, assemble logger evidence, calculate exact exposure, identify the affected physical population, and make stability-backed disposition decisions without reconstructing a journey from emails.
Competency enforced at point of work. AI-configured curricula per role. Unified with QMS, MES, and LIMS.
Connect packaging orders, serial numbers, UDI or product identifiers, commissioning, aggregation, labels, exceptions, EPCIS exchange, warehouse events, verification, and recall.
Connect supplier qualification, purchase and shipment data, container receipt, quarantine, sampling plans, identity and specification testing, status labels, expiry, release, and manufacturing eligibility.
Control regulated-system inventory, intended use, function risk, supplier evidence, right-sized testing, releases, changes, and periodic review without turning validation into a document factory.
Labels generated from live records, not retyped into Bartender. Every scan linked. Unified with MES, LIMS, and Inventory.
Govern manual and automated visual inspection, defect libraries, inspector qualification, challenge sets, reject genealogy, investigations, reconciliation, trending, and finished-batch disposition.
Run Manufacturing Science and Technology across process ownership, technology transfer, site and product knowledge, batch monitoring, process signals, investigations, change impact, validation and CPV, improvement, comparability, commitments, and governed manufacturing support.
Control master and working cell banks, viral and microbial seed lots, strains, characterization, cryogenic locations, vial withdrawal, passage, suitability, and downstream manufacturing impact.
Analytical target profiles, experiments, method parameters, chromatographic and spectral evidence, forced degradation, robustness, control strategy, validation readiness, transfer, and lifecycle knowledge connected to ELN, SDMS, LIMS, instruments, and standards.
Source-approved results, specification versions, reportable-value rules, batch and material identity, template applicability, statements, multilingual rendering, review, signature, issue, amendment, supersession, portal delivery, API data, and acknowledgement.
Barcode verification blocks wrong materials. Balance data direct, no transcription. Unified with MES, LIMS, and Inventory.
Control single-use assembly designs, supplier components, sterilization, extractables and leachables, build and installation, connections, integrity tests, use windows, product contact, and disposition.
Manage process characterization strategy, prior knowledge, risk assessments, DoE and edge-of-failure studies, parameter-to-quality relationships, scale and platform models, proven ranges, design-space claims, control-strategy decisions, and validation handoff.
Chemical approval, inventory, SDS versions, GHS labels, storage compatibility, quantity limits, risk assessment, exposure controls, inspections, incidents, hazardous waste, emergency inventory, and jurisdiction-aware reporting.
Plan and execute cleanroom cleaning and disinfection by area and surface, control agent preparation and rotation, prove coverage and contact time, assess missed work, verify effectiveness, and govern return to use.
Govern PAT methods, sensors, chemometric models, calibration sets, predictions, process actions, model lifecycle, RTRT strategies, fallback testing, and batch-release evidence.
Run cell-culture and fermentation development with governed cell lineage, media and feed versions, executable recipes, connected bioreactors, samples and assays, clone and process comparisons, scale-up models, perfusion state, harvest decisions, characterization, and technology transfer.
Assess post-approval CMC changes across products and markets, govern established conditions and PACMPs, assemble comparability evidence, track authority outcomes, and prevent premature implementation.
Run purification and formulation development with governed harvest inputs, buffers and solutions, chromatography and filtration methods, column and membrane lifecycle, fractions and pools, samples and assays, yield and clearance balances, holds, scale-up models, characterization, and technology transfer.
ICH-aligned and custom stability protocols, batches, packaging configurations, chambers, sample inventory, pull windows, chain of custody, testing, trends, statistical analyses, excursions, OOS and OOT, shelf-life proposals, commitments, annual placement, reports, and archive.
Control DEA registrations, schedules and authority, receipts, vault inventory, manufacturing issues and yields, transfers, returns, waste, destruction, physical inventories, reconciliation, and loss reporting.
Submission strategy, content plans, dossiers, source data, authoring, claims, references, reviews, translations, eCTD lifecycle, technical validation, dispatch, acknowledgements, health-authority questions, commitments, and approved-state updates.
Govern lyophilization recipes, product and load configurations, loading and stoppering, chamber readiness, source cycle data, endpoints, exceptions, unload genealogy, quality results, validation, and release.
Inspection preparation, readiness assessments, front- and back-room request control, scoped evidence packages, point-in-time verification, secure review, response approval, commitments, observations, metrics, and continuous remediation across GxP systems.
The governed workflow for document requests, authorship, review, approval, change impact, training, effective dates, controlled copies, periodic review, supersession, and archival—composed with DMS, training, change control, and validation.
Receive supplier change notifications, establish affected supplied items and lots, calculate where-used impact, plan evidence, respond to the supplier, govern inventory transition, and authorize implementation by product and market.
Capture manufacturing, laboratory, facility, equipment and data deviations with live context; control containment and notifications; classify and scope impact; plan and execute evidence-based investigations; test hypotheses and recurrence; approve root cause and product decisions; connect CAPAs and changes; verify effectiveness; trend systemic signals; and close with complete rationale.
Govern container-closure configurations, critical quality attributes, CCIT methods, positive controls and standards, validation, routine and stability studies, transport challenges, results, investigations, trending, and lifecycle decisions.
Effectiveness verification as a gate, not a checkbox. AI-drafted CAPA plans from similar historical events. Unified with QMS and MES.
Map product-contact systems, characterize materials, plan extractables and leachables studies, calculate exposure and analytical evaluation thresholds, identify compounds, govern toxicological assessments, justify bracketing, and manage lifecycle change.
CC-2024-047 was approved in January. Six months later, the procedure still showed the old process. Implementation tracking that ensures changes actually happen.
Govern sterilizing filtration strategies, filter and assembly configurations, bacterial-retention and product-specific validation, sterilization and installation, PUPSIT and post-use integrity testing, process parameters, interventions, failures, and batch disposition.
Govern product and API nitrosamine risk assessments, amine and nitrosating-agent knowledge, formation pathways, acceptable-intake limits, confirmatory methods and testing, mitigation, stability, supplier dependencies, regulatory reporting, and lifecycle review.
Govern aseptic roles, curricula, gowning qualifications, practical assessments, APS participation, intervention authorization, cleanroom access, personnel monitoring, observations, restrictions, requalification, and live execution eligibility.
Capture product complaints across channels, preserve awareness, separate quality and safety assessments, investigate with lot and return evidence, report under governed rules, trend signals, and close the customer loop.
Govern biologics viral safety strategies, source and cell-substrate risk, virus testing, adventitious-agent methods, scaled-down clearance models, spiking studies, log-reduction calculations, step and process claims, lifecycle changes, and batch-release dependencies.
Material, component, product and process nonconformances with immediate segregation, affected-population trace, evaluation, MRB review, rework, repair, return, scrap, concession, execution, effectiveness, supplier linkage, and trending.
The traceability matrix showed Input → Output → Verification for every requirement except one. Class I recall followed. Live traceability that exposes gaps before auditors do.
Monitor USP, Ph. Eur., JP and other compendial changes, compare requirements, calculate product and market impact, evaluate methods and specifications, plan laboratory and regulatory evidence, govern dual-state implementation, and prove timely compliance.
Qualification history, calibration, and verification in one record. AI-drafted IQ/OQ/PQ protocols. Unified with Equipment and QMS.
Plan risk-based internal, supplier and regulatory audit programs; qualify auditors; prepare scope and evidence; execute agendas, interviews and sampling; govern observations and findings; coordinate responses, CAPAs and commitments; verify effectiveness; trend themes; manage inspection rooms; and close with a complete record.
Connect materials, electronic batch records, QC, equipment, quality events, labels, stability, and release without rebuilding the batch across systems.
The operating architecture, master data, validation, cutover, and receipt-to-release proving path for a new GMP manufacturing site.
Connect sterile compounding and fill-finish, contamination control, environmental monitoring, interventions, qualification, microbiology, and release.
Samples, instruments, specifications, OOS, stability, environmental monitoring, and CoA generation in one GMP laboratory flow.
Every cell knows its patient. AI-configured for autologous and allogeneic. Unified with LIMS, MES, and QMS.
Cell-bank genealogy, upstream execution, downstream pools, single-use assemblies, process analytics, viral safety, and release in one commercial record.
ISO 13485, EU MDR, FDA 21 CFR 820. Design controls through post-market surveillance. When the auditor asks to see requirement 47, you click once.
R&D flexibility. GMP compliance. No migration.
Per-client data isolation without vendor consultants. AI-configured Blueprints per client. Unified with MES, LIMS, and QMS.
Pharmaceutical-grade batch records and EM trending. AI-configured for 503B workflows. Unified with LIMS and QMS.
Seed and antigen genealogy, formulation, filling, potency and sterility testing, cold chain, release protocols, and regulator-facing lot evidence.
Decay-aware production, synthesis and cassette genealogy, rapid QC, patient-dose dispensing, transport, equipment state, and post-release evidence.
Material genealogy and electronic batch execution from dispensing through granulation, compression, coating, packaging, and release.
Drug or biologic genealogy joined to device configuration, assembly, essential performance, design change, complaints, and final release.
Electronic batch execution and genealogy across raw materials, reactions, intermediates, equipment, process testing, quality, and release.
Run AAV, lentiviral, and other viral-vector production with plasmid and bank genealogy, transfection, harvest, purification, potency, vector safety, fill, cryostorage, and release.
Run solid- and liquid-phase peptide synthesis, fragment condensation, cleavage, deprotection, purification fractions, pooling, conjugation, counterion exchange, drying, analytical control, mass balance, and release.
Consent travels with the sample. Provenance for every aliquot. Unified with ELN, LIMS, and QMS.
Connect donor eligibility, starting material, master and working cell banks, engineering, expansion, harvest, formulation, dose lots, potency, cryostorage, allocation, and patient impact.
Run quotes, client methods and specifications, sample accessioning, chain of custody, capacity, testing, OOS, QA review, COAs, portals, retain storage, and billing.
Run phosphoramidite synthesis, cycle-level material control, cleavage and deprotection, purification fractions, pooling, conjugation, duplexing, ultrafiltration, lyophilization, analytical testing, and release.
Orchestrate treatment orders, collection, chain of identity and custody, patient-specific manufacturing, QC, cryogenic storage, release, logistics, and treatment-center handoffs.
Connect DNA template, in-vitro transcription, purification, lipid nanoparticle formulation, sterile fill, analytical data, cold chain, deviations, and lot release.
Connect antibody and linker-payload supply, potent-compound control, conjugation, purification, DAR analytics, material balance, cleaning, fill finish, partner handoffs, and release.
Operate continuous drug-substance and drug-product processes with time-based material genealogy, residence-time distributions, process-state classification, PAT and active controls, disturbance management, diversion, collection, batch definition, review, validation, and release.
Run metered-dose inhaler, dry-powder inhaler, nebulized solution and suspension manufacturing with formulation and device configuration, component genealogy, filling and assembly, conditioning, delivered-dose and aerodynamic testing, stability, investigations, and release.