Start with a blueprint.
Make it yours.
133 starting points for manufacturing, laboratory and quality operations on Seal. Adapt the workflows with Neil, your AI agent, then improve them from the evidence of each run.
133 blueprints and 7 worked examples
Systems
- 123Batch record
Manufacturing execution
→Run your batch process and improve the next version from its evidence.
- Finding!Action
Quality management
→Connect findings, corrective actions and evidence of effectiveness.
- Sample → Result
QC laboratory
→Follow samples from receipt through testing and result review.
- Experiment
Electronic lab notebook
→Configure structured protocols and compare experiments with Neil.
- Lot ALot BLot C
Inventory management
→Track material status, location and use across your operation.
- Study visits
Clinical operations
→Bring study, site and participant work into a connected review.
Equipment lifecycle
→Connect equipment use, maintenance, calibration and qualification.
Document management
→Control procedure versions and the work each revision affects.
Clinical trial management
→Coordinate sites, milestones and outstanding trial work.
Regulatory information
→Track product registrations, market requirements and commitments.
Product lifecycle
→Carry product and process knowledge from development into manufacturing.
Patient orchestration
→Coordinate patient milestones with collection, manufacturing and treatment.
Learning management
→Connect training assignments and qualification to the work people do.
Maintenance management
→Plan maintenance and keep work orders with equipment history.
Warehouse management
→Manage material receipt, storage, movement and permitted use.
Trial master file
→Organise essential trial documents and identify missing evidence.
Clinical data capture
→Connect case report forms, queries and controlled database review.
Scientific data
→Keep instrument files and metadata connected to laboratory work.
Sample management
→Trace sample identity, custody, storage and use.
Workflows
Technology transfer
→Transfer process knowledge, requirements and readiness evidence between teams.
Electronic batch records
→Turn manufacturing instructions into execution and review records.
Process development
→Compare experiments and carry the selected process forward.
Drug safety
→Connect safety intake, case assessment, reporting and signal review.
Quality reporting
→Prepare reports with the source records behind each conclusion.
Environmental monitoring
→Link environmental results to locations, operations and investigations.
Device history records
→Keep manufacturing evidence and exceptions with each device or lot.
Supplier quality
→Review supplier scope, performance and outstanding quality actions.
Batch review and release
→Neil reviews every lot overnight; QA decides on a short brief.
Clinical trial supply
→Coordinate trial material availability, blinding and accountability.
Cleaning validation
→Connect cleaning limits, execution, samples and equipment status.
Electronic logbooks
→Record equipment and facility events in their operational context.
OOS and OOT investigations
→Trace unexpected results through methods, samples and investigation evidence.
Audit trail review
→Review changes and events alongside the records they affect.
Process validation and PPQ
→Connect protocols, execution evidence and process validation conclusions.
Quality risk management
→Connect risk assessments, controls and supporting evidence.
Microbiology laboratory
→Track plates, organisms and results back to samples and batches.
Commissioning and qualification
→Trace equipment and facility requirements through qualification testing.
Media fills
→Plan aseptic process simulations and review intervention evidence.
Specification management
→Keep limits, methods and effective versions with the materials they govern.
CMC knowledge
→Connect product and process claims to their source evidence.
Regulatory change impact
→Assess how quality changes affect market commitments and requirements.
Product quality reviews
→Bring batch trends, deviations and changes into the annual review.
Analytical method lifecycle
→Carry methods through development, validation, transfer and routine use.
Contamination control
→Connect contamination risks to controls and evidence of performance.
Packaging and line clearance
→Check components, clearance and reconciliation within the packaging record.
Water and clean utilities
→Connect utility monitoring, points of use and potentially affected batches.
Continued process verification
→Review process trends and investigate changes in performance.
Calibration and metrology
→Track calibration status and assess the impact of failed checks.
Standards and reagents
→Track preparation, expiry and use of laboratory materials.
Quality agreements
→Connect partner responsibilities to review tasks and evidence.
Sterilisation loads
→Keep load contents, cycle evidence and exceptions together.
Recalls and market actions
→Identify affected populations and track contact, response and effectiveness.
Cold chain and excursions
→Connect temperature records, handoffs and affected material disposition.
Training and qualification
→Track who is qualified for each task and procedure version.
Serialisation
→Reconcile unit, case and pallet identities with distribution events.
Raw material release
→Connect receipt, sampling and testing before material use.
Computer system assurance
→Scope critical functions and retain the evidence behind each release.
Labels and barcodes
→Keep label identity and content connected to the item being labelled.
Visual inspection
→Reconcile inspected units, defect categories and inspection decisions.
Manufacturing science
→Connect process knowledge, manufacturing signals and improvement work.
Cell banks and seed lots
→Trace source material, generations, storage and authorised use.
Analytical development
→Connect method experiments and performance to the intended analytical purpose.
Certificates of analysis
→Prepare certificates from reviewed results and applicable specifications.
Weigh and dispense
→Check material identity and quantities against the manufacturing instruction.
Single-use assemblies
→Trace component lots and product-contact paths through assembly and use.
Process characterisation
→Connect experimental studies to operating ranges and control decisions.
Chemical safety
→Keep substance hazards, containers, locations and disposal records together.
Buffer and media preparation
→Run preparation protocols with recipe versions, actual additions, checks and use traceability.
Cleanroom cleaning
→Record coverage, contact times and review of cleaning activities.
PAT and real-time release testing
→Connect process signals, quality predictions and release assessment.
Upstream process development
→Compare bioreactor runs, feed strategies and culture performance.
Cell line development
→Compare clone screening, clonality, quality and stability evidence.
Post-approval CMC changes
→Track market pathways and implementation conditions for technical changes.
Downstream process development
→Compare chromatography runs, fraction assays and filtration studies.
Stability studies
→Plan pulls and review results against study conditions and limits.
Controlled substances
→Reconcile authorised movements and investigate inventory discrepancies.
Regulatory submissions
→Organise submission content with its supporting evidence and versions.
Paper records to data
→Read scanned batch records and logbooks into data, each value linked to its page.
Lyophilisation
→Connect load configuration, cycle phases and freeze-drying exceptions.
Inspection readiness
→Organise requests, evidence scope and the material shared with inspectors.
Document control
→Manage authoring, approval, distribution and retirement of controlled documents.
Material demand planning
→Each material’s cover at the rate you use it now, with proposals planners decide.
Supplier change notifications
→Assess external changes against affected materials, processes and filings.
Deviations and investigations
→Connect what happened, the affected work and investigation conclusions.
Container closure integrity
→Connect package configurations, test methods and integrity evidence.
Corrective and preventive actions
→Track actions through implementation and effectiveness review.
Customer forecast intake
→Read every customer’s forecast into one shape and ask before trusting a change.
Supplier order follow-up
→Hold supplier email against every open order and draft the follow-up for the buyer.
Supplier scorecards
→Count delivery and quality from every receipt, each number linked to its records.
Production schedule alignment
→Lay the ERP, the planner’s spreadsheet and the project plan over one another.
Extractables and leachables
→Connect contact materials, analytical findings and toxicological assessment.
Change control
→Carry a proposed change through impact assessment and implementation.
Certificate review
→Read each supplier certificate against your specification, the ERP’s lot and the lots before it.
Sterile filtration
→Link filter assemblies, integrity tests and affected product populations.
Supplier changes
→Find supplier changes wherever they arrive and work out the notice each customer is owed.
Nitrosamine risk
→Connect formation risks, analytical results and mitigation work.
Order promising
→Answer each customer’s ask from the material and the line, not the ERP’s lead time.
Aseptic operator qualification
→Connect observed practice, gowning results and permitted activities.
Product complaints
→Connect the reported issue, affected product and investigation response.
Invoice matching
→Hold supplier invoices against the PO, the receipt and each other, to find what the match lets through.
Viral safety and clearance
→Trace viral safety assessments and clearance claims to study evidence.
Nonconformance and material review
→Track containment, assessment and disposition of nonconforming material.
S&OP pre-read
→Write the S&OP pre-read from the week’s findings: what to decide, stop and recover, and what won’t wait.
Device design control
→Connect design requirements, risks, verification and validation evidence.
Compendial changes
→Trace pharmacopoeial updates to affected methods and specifications.
Validation management
→Keep requirements, test evidence and review decisions connected.
Audit management
→Plan audits and carry findings into accountable follow-up work.
Industries
Pharmaceutical manufacturing
→Connect material receipt, production, laboratory testing and batch review.
New facility launch
→Bring equipment, procedures and operational readiness into one setup.
Sterile injectables
→Connect aseptic execution, environmental monitoring and quality review.
Pharmaceutical QC
→Coordinate laboratory work with the batches waiting for results.
Cell and gene therapy
→Connect patient or donor identity, manufacturing and product evidence.
Biologics manufacturing
→Trace cell banks, process stages and batch evidence through production.
Medical devices
→Connect design controls, manufacturing records and quality processes.
Biotech R&D
→Carry experiments and process knowledge into quality and manufacturing work.
Contract manufacturing
→Coordinate campaigns, client requirements and shared review evidence.
503B outsourcing facilities
→Connect compounding execution, testing and facility quality records.
Vaccine manufacturing
→Trace production stages, testing and lot release dependencies.
Radiopharmaceuticals
→Coordinate time-sensitive production, testing and dose readiness.
Oral solid dose
→Connect dispensing, processing, packaging and material reconciliation.
Combination products
→Bring drug and device evidence into a coordinated product review.
API manufacturing
→Trace material transformations, intermediates and finished API evidence.
Gene therapy and viral vectors
→Connect plasmids, cells and vector production to product testing.
Peptide manufacturing
→Trace synthesis, purification and pooling through the process.
Biobanking
→Keep specimen lineage, storage and consent restrictions together.
Allogeneic cell therapy
→Connect donor lineage, manufacturing lots and resulting doses.
Contract testing laboratories
→Coordinate sample work, client requirements and result delivery.
Oligonucleotide manufacturing
→Trace sequence-driven synthesis, purification and pool decisions.
Autologous cell therapy
→Keep patient identity with collection, manufacturing and treatment readiness.
mRNA manufacturing
→Connect sequence, template, processing and formulation evidence.
Antibody-drug conjugates
→Trace antibody, linker-payload and conjugation through manufacturing.
Continuous manufacturing
→Connect process disturbances and material movement to batch boundaries.
Inhalation products
→Bring formulation, device components and delivered-dose testing together.
Blueprints in practice.
Example records, worked through: the fields to keep, how Seal checks them, and the line each case turns on.
- RCV-482-AS-482-01ResolvedRCV-482-BS-482-02ResolvedRCV-482-CUnreadableUnresolved
- Before12 events in 150 runs8.00After5 events in 60 runs8.33RateEvents per 100 eligible runs
- J. Patelv04, assessedAuthorisedM. Chenv03, reassessment dueReview requiredA. Lewisv04, not assessedNot authorised
- B-208-AIn progressRevision 4B-208-BCreated, not startedResolve firstB-208-CCreated afterRevision 5
- IssuedISS-44025.000 kgAccountedUsed, returned, waste, sample24.950 kgDifferenceREC-4400.050 kg
- C-731-01Q-04DecidedC-731-02A-12, not Q-04Unrecorded moveC-731-03Q-04Awaiting
- ParentC-20410.000 kgAccounted3 children, sample, residual9.980 kgDifferenceSPL-2040.020 kg
Bring the process you need.
Bring your procedure. We’ll scope the workflow and its checks with you. Your team tests and approves it before use.
See how configuration works →