119 GxP blueprints.
Starting points for the work you need to run. neil configures the process in Seal; your team reviews, tests and approves it.
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Systems
Pharmaceutical MES & Manufacturing Execution
neil is the AI agent. Seal is the platform where manufacturing, lab and quality run together. Investigate a result, configure a process and carry what you learn into the next run.
GxP Quality Management System (eQMS)
Investigate with the execution record, then change how the work runs. neil and built-in continuous validation connect findings, controls and approved improvements.
Pharmaceutical QC LIMS
Run the lab on the same platform as manufacturing and quality. neil helps configure methods and investigate results, with evidence and change control built in.
Electronic Laboratory Notebook (ELN)
Run experiments alongside samples, instruments and quality in Seal. neil helps configure the work, investigate results and turn findings into controlled improvements.
Pharmaceutical Inventory Management
Connect each container to its quantity, commitments, storage history and actual use. Plan with the evidence, investigate with neil, and keep material decisions with the work they affect.
Clinical Operations Management
EDC, CTMS, and eTMF share one data model. Sites enter data once. Documents file themselves. Queries resolve in context.
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GxP Equipment & Asset Lifecycle Management
Keep qualification, calibration and maintenance connected to every batch and test. Use neil to investigate equipment issues, with change control built into Seal.
GxP Document Management System (DMS) & Document Control
Control the instruction. Connect it to training and execution. Improve it with neil—with change control and continuous validation built into the same platform.
Clinical Trial Management System (CTMS)
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.
Regulatory Information Management System (RIMS)
Products, registrations, dossiers, submissions, health-authority correspondence, commitments, labeling, regulatory intelligence, and market-specific change assessments in one global regulatory record.
Life Sciences Product Lifecycle Management (PLM)
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.
GxP Learning Management System (LMS)
Connect procedures, training and practical evidence to the work people perform. neil helps configure the requirements; your team assesses competence and approves the scope.
GxP Computerized Maintenance Management System (CMMS)
Connect maintenance to production, laboratory and quality. Ask neil to investigate recurring faults, prepare the work and build better maintenance workflows—with the evidence and changes ready for your review.
Pharmaceutical Warehouse Management System (WMS)
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.
Electronic Trial Master File (eTMF)
Seal builds the TMF from the trial itself. Study, country, site, and vendor events create expected evidence; every artifact carries provenance, QC, filing, and replacement history; every gap has an owner.
Clinical Electronic Data Capture (EDC)
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.
Scientific Data Management System (SDMS)
Capture instrument files with Seal Edge. Keep the originals, metadata and review history connected to the sample, batch or investigation in Seal.
Laboratory & Biorepository Sample Management
Connect collection, custody and aliquot lineage to the work that uses each sample. Use neil to investigate its history, plan scarce allocations and build the workflow in Seal.
Workflows
Pharmaceutical Technology Transfer Management
Seal transfers the process as data.
Electronic Batch Record
Author, execute, review, and release GMP batch records with material and equipment checks, automated data capture, controlled exceptions, and complete history.
Pharmaceutical & Bioprocess Development
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.
Pharmacovigilance & Drug Safety Management
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.
GxP Automated Reporting & Quality Intelligence
Controlled report definitions, governed metrics, frozen data cuts, traceable tables and narratives, review, approval, scheduling, distribution, and live quality intelligence across GxP operations.
Pharmaceutical Environmental Monitoring
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.
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Electronic Device History Record
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.
Pharmaceutical Supplier Quality Management
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.
Pharmaceutical Batch Review & Release
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.
Clinical Supply Management
Protocol demand, kit and label design, packaging, randomization identifiers, depot and site inventory, temperature, returns, and reconciliation.
Pharmaceutical Cleaning Validation
Connect product and equipment matrices, residue limits, worst-case rationale, cleaning instructions, swab and rinse samples, deviations, and continued verification.
Pharmaceutical Electronic Logbook
Replace paper equipment, area, utility, and shift logs with structured GMP entries, live status, task handoffs, exception workflows, and traceable review.
OOS & OOT Laboratory Investigation
Run laboratory assessment, hypothesis testing, manufacturing investigation, batch impact, CAPA, trending, and disposition without losing the original result or scientific rationale.
Pharmaceutical Data Integrity & Audit Trail Review
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.
Pharmaceutical Process Validation & PPQ
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.
Life Sciences Quality Risk Management & ISO 14971
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.
Pharmaceutical Microbiology LIMS
Run environmental monitoring, sterility, bioburden, endotoxin, utilities, growth promotion, incubation, organism identification, excursions, trending, and release.
Pharmaceutical CQV
Plan and execute facility, utility, equipment, automation, and computerized-system CQV from requirements and risk through turnover, testing, exceptions, release, and continued qualified state.
Aseptic Process Simulation & Media Fill Management
Design APS coverage across lines, shifts, operators, interventions, container configurations, campaign conditions, incubation, unit reconciliation, failures, and requalification.
Pharmaceutical Specification Management
Control material, in-process, release, and stability specifications across products, sites, markets, methods, sampling plans, lifecycle stages, changes, testing, and disposition.
CMC Data & Module 3 Content Management
Connect product definitions, processes, specifications, methods, characterization, validation, stability, claims, CTD sections, market variants, review, and post-approval change without rebuilding truth in documents.
Regulatory Change Impact & Commitment Management
Connect QMS changes, health-authority commitments, market assessments, submission dependencies, implementation controls, and closure evidence without turning the QMS into a second RIMS.
Annual Product Quality Review
Continuously assemble batches, results, deviations, changes, stability, complaints, supplier evidence, process capability, conclusions, and follow-up actions.
Analytical Method Lifecycle, Validation & Transfer
Connect analytical target profiles, development knowledge, validation characteristics, transfer protocols, method versions, instruments, specifications, and routine monitoring.
Contamination Control Strategy & Sterility Assurance
Build and maintain a living CCS across facility, people, utilities, cleaning, sterilization, aseptic process, monitoring, investigations, trends, changes, and sterility assurance review.
Pharmaceutical Packaging, Line Clearance & Reconciliation
Control packaging orders, line readiness, components and printed materials, coding, in-process checks, rejects, rework, label reconciliation, aggregation, yields, deviations, and packaged-batch release.
Pharmaceutical Water & Clean Utilities Management
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.
Continued Process Verification
Monitor version-aware process parameters, material attributes, equipment, yields, holds, deviations, and quality attributes with governed populations, signals, and actions.
Pharmaceutical Calibration & Metrology Management
Connect calibration to the tests, batches and decisions that use the instrument. Keep the original evidence. Ask neil to investigate drift and build the next controlled procedure.
Laboratory Standards, Reagents & Solution Preparation
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.
Pharmaceutical Quality Agreements & External Partner Governance
Make sponsor, CDMO, laboratory, supplier, packaging, storage, and distribution responsibilities executable across notifications, investigations, record exchange, release, escalation, performance, and review.
Pharmaceutical Sterilization & Autoclave Load Management
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.
Product Recall & Market Action Management
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.
Pharmaceutical Cold Chain & Temperature Excursion Management
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.
GxP Training & Qualification Management
Competency enforced at point of work.
Pharmaceutical Serialization & Track-and-Trace
Connect packaging orders, serial numbers, UDI or product identifiers, commissioning, aggregation, labels, exceptions, EPCIS exchange, warehouse events, verification, and recall.
Pharmaceutical Raw Material Receipt, Sampling & Release
Connect supplier qualification, purchase and shipment data, container receipt, quarantine, sampling plans, identity and specification testing, status labels, expiry, release, and manufacturing eligibility.
GxP Computer System Validation (CSV) & Computer Software Assurance (CSA)
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.
Pharmaceutical Labeling & Barcode Management
Labels generated from live records, not retyped into Bartender. Every scan linked. Unified with MES, LIMS, and Inventory.
Pharmaceutical Visual Inspection & Defect Management
Govern manual and automated visual inspection, defect libraries, inspector qualification, challenge sets, reject genealogy, investigations, reconciliation, trending, and finished-batch disposition.
MSAT Process Knowledge & Manufacturing Support
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.
Biologics Cell Bank, Seed Lot & Strain Management
Control master and working cell banks, viral and microbial seed lots, strains, characterization, cryogenic locations, vial withdrawal, passage, suitability, and downstream manufacturing impact.
Pharmaceutical Analytical Development
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.
Pharmaceutical Certificate of Analysis (CoA) Generation
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.
Pharmaceutical Weigh & Dispense
Barcode verification blocks wrong materials. Balance data direct, no transcription. Unified with MES, LIMS, and Inventory.
Single-Use Systems & Assembly Lifecycle Management
Control single-use assembly designs, supplier components, sterilization, extractables and leachables, build and installation, connections, integrity tests, use windows, product contact, and disposition.
Pharmaceutical Process Characterization
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 Inventory, SDS & EHS Management
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.
Cleanroom Cleaning & Disinfection Management
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.
Pharmaceutical PAT & Real-Time Release Testing
Govern PAT methods, sensors, chemometric models, calibration sets, predictions, process actions, model lifecycle, RTRT strategies, fallback testing, and batch-release evidence.
Bioprocess Upstream Development
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.
Post-Approval CMC Change & PACMP Management
Assess post-approval CMC changes across products and markets, govern established conditions and PACMPs, assemble comparability evidence, track authority outcomes, and prevent premature implementation.
Bioprocess Downstream Development
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.
Pharmaceutical Stability Study Management
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.
Controlled Substance Inventory & DEA Recordkeeping
Control DEA registrations, schedules and authority, receipts, vault inventory, manufacturing issues and yields, transfers, returns, waste, destruction, physical inventories, reconciliation, and loss reporting.
eCTD Regulatory Submission Management
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.
Pharmaceutical Lyophilization & Freeze-Drying Cycle Management
Govern lyophilization recipes, product and load configurations, loading and stoppering, chamber readiness, source cycle data, endpoints, exceptions, unload genealogy, quality results, validation, and release.
GxP Inspection Readiness & Regulatory Request Management
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.
GxP Document Control Workflow
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.
Pharmaceutical Supplier Change Notification Management
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.
GxP Deviation & Investigation Management
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.
Container Closure Integrity Testing (CCIT)
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.
GxP CAPA Management
Effectiveness verification as a gate, not a checkbox. AI-drafted CAPA plans from similar historical events. Unified with QMS and MES.
Pharmaceutical Extractables & Leachables (E&L) Management
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.
GxP Change Control
CC-2024-047 was approved in January. Six months later, the procedure still showed the old process. Implementation tracking that ensures changes actually happen.
Sterile Filtration Validation & PUPSIT Management
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.
Pharmaceutical Nitrosamine Risk Assessment & Control
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.
Aseptic Operator & Gowning Qualification
Govern aseptic roles, curricula, gowning qualifications, practical assessments, APS participation, intervention authorization, cleanroom access, personnel monitoring, observations, restrictions, requalification, and live execution eligibility.
Product Complaint Handling & Safety Intake
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.
Biologics Viral Safety & Viral Clearance Management
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.
GxP Nonconformance & Material Review Board
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.
Medical Device Design Control
The traceability matrix showed Input → Output → Verification for every requirement except one. Class I recall followed. Live traceability that exposes gaps before auditors do.
Pharmacopoeial & Compendial Change Management
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.
GxP Validation Management
Qualification history, calibration, and verification in one record. AI-drafted IQ/OQ/PQ protocols. Unified with Equipment and QMS.
GxP Audit & Inspection Management
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.
Industries
Pharmaceutical Manufacturing
Connect materials, electronic batch records, QC, equipment, quality events, labels, stability, and release without rebuilding the batch across systems.
Greenfield Pharmaceutical Facility Launch
The operating architecture, master data, validation, cutover, and receipt-to-release proving path for a new GMP manufacturing site.
Aseptic Manufacturing
Connect sterile compounding and fill-finish, contamination control, environmental monitoring, interventions, qualification, microbiology, and release.
Pharmaceutical LIMS for QC Laboratories
Samples, instruments, specifications, OOS, stability, environmental monitoring, and CoA generation in one GMP laboratory flow.
Cell & Gene Therapy Manufacturing
Every cell knows its patient.
Biopharma MES & Biologics Manufacturing
Cell-bank genealogy, upstream execution, downstream pools, single-use assemblies, process analytics, viral safety, and release in one commercial record.
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Medical Device QMS & Manufacturing
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.
Biotech Startup R&D, Quality & Manufacturing
Connect ELN, inventory, samples, process and analytical development, QMS, tech transfer, CDMO oversight, and CMC evidence as a biotech program moves toward GMP.
CDMO Manufacturing & Quality Management
Per-client data isolation without vendor consultants.
503B Outsourcing Facility Management
Pharmaceutical-grade batch records and EM trending.
Vaccine MES & Lot Release
Seed and antigen genealogy, formulation, filling, potency and sterility testing, cold chain, release protocols, and regulator-facing lot evidence.
Radiopharmacy Management Software & PET LIMS
Decay-aware production, synthesis and cassette genealogy, rapid QC, patient-dose dispensing, transport, equipment state, and post-release evidence.
Oral Solid Dose MES & Electronic Batch Records
Material genealogy and electronic batch execution from dispensing through granulation, compression, coating, packaging, and release.
Combination Product QMS
Drug or biologic genealogy joined to device configuration, assembly, essential performance, design change, complaints, and final release.
API Manufacturing
Electronic batch execution and genealogy across raw materials, reactions, intermediates, equipment, process testing, quality, and release.
Gene Therapy & Viral Vector Manufacturing
Run AAV, lentiviral, and other viral-vector production with plasmid and bank genealogy, transfection, harvest, purification, potency, vector safety, fill, cryostorage, and release.
Peptide Manufacturing Software for GLP-1 & Synthetic Peptide APIs
Run solid- and liquid-phase peptide synthesis, fragment condensation, cleavage, deprotection, purification fractions, pooling, conjugation, counterion exchange, drying, analytical control, mass balance, and release.
Biobank & Biorepository Management
Connect consent, provenance and scientific quality to every research request. Use neil to investigate the evidence, prepare linked work and build the workflow in Seal.
Allogeneic Cell Therapy Manufacturing
Connect donor eligibility, starting material, master and working cell banks, engineering, expansion, harvest, formulation, dose lots, potency, cryostorage, allocation, and patient impact.
Contract Testing Laboratory LIMS & Client Portal
Run quotes, client methods and specifications, sample accessioning, chain of custody, capacity, testing, OOS, QA review, COAs, portals, retain storage, and billing.
Oligonucleotide Manufacturing Software for ASO & siRNA
Run phosphoramidite synthesis, cycle-level material control, cleavage and deprotection, purification fractions, pooling, conjugation, duplexing, ultrafiltration, lyophilization, analytical testing, and release.
Autologous Cell Therapy Orchestration & Manufacturing
Run patient orchestration, manufacturing, laboratory, quality, release, and return as one patient-specific operating case—with identity, custody, and evidence intact.
mRNA Manufacturing
Connect DNA template, in-vitro transcription, purification, lipid nanoparticle formulation, sterile fill, analytical data, cold chain, deviations, and lot release.
Antibody-Drug Conjugate Manufacturing
Connect antibody and linker-payload supply, potent-compound control, conjugation, purification, DAR analytics, material balance, cleaning, fill finish, partner handoffs, and release.
Continuous Pharmaceutical Manufacturing
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.
Inhalation Drug Product Manufacturing
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.
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