Quality agreements. Turn written responsibilities into routed work, evidence, and accountable decisions.

A quality agreement is not a contract attachment that becomes obsolete after signature. It is the operational boundary between parties: who performs, reviews, approves, notifies, investigates, supplies records, releases, retains, audits, and escalates each regulated activity.

Seal turns those responsibilities into governed obligations connected to actual products, sites, services, batches, samples, changes, deviations, results, records, notifications, performance, and decisions. Both parties can prove that the agreed operating model is the one being used.

FDA's quality agreements guidance for contract drug manufacturing is the primary US reference for defining and documenting the parties' manufacturing activities while preserving each party's CGMP responsibilities.

Legal entity, site, role, license or registration, authorized contacts, quality unit, service, product, material, market, lifecycle stage, subcontractors, and effective dates establish scope.

Manufacturing, testing, release, packaging, labeling, serialization, storage, transport, stability, complaint handling, pharmacovigilance, and record retention can be included independently. Commercial terms remain outside the quality workflow unless they create a regulated obligation.

Executable quality-agreement matrix

Written responsibilities resolve against the product, service, site and actual event—with evidence and timing attached.

Applicability

Product, market, site, method and subcontractor determine which duty applies.

Authority

Performing work and owning the final decision remain distinct responsibilities.

Evidence

Deliverable, source, deadline and escalation are part of every obligation.

Gap

Uncovered subcontracted work is blocked rather than hidden in a signed PDF.

Each activity identifies accountable party, performer, reviewer, approver, consulted parties, notification recipients, evidence provider, timing, service level, governing procedure, applicable product or site, escalation, and required records.

The controlled narrative is generated from those obligations. Ambiguous overlaps and unassigned activities become visible before approval.

One relationship can cover several products, methods, dosage forms, sites, and markets with different responsibility patterns. Applicability rules show which obligation governs each actual batch or sample.

A corporate template can supply defaults without pretending that an aseptic CDMO, contract microbiology laboratory, packager, and warehouse require the same controls.

The agreement identifies whose procedure governs, where it is available, how differences are reconciled, who authors and approves records, which system is authoritative, required format, access, certified copies, retention, archival, retrieval, and inspection support.

System access does not transfer accountability. Each party retains the signatures and decisions assigned to it.

Process, material, supplier, method, specification, equipment, site, utility, software, facility, packaging, test, subcontractor, or regulatory change can trigger pre-approval, prior notification, prompt notification, or periodic reporting.

The system resolves applicable obligations, required information, recipients, due clocks, assessments, questions, approvals, implementation conditions, and effective state.

Notification thresholds, timelines, immediate containment, investigation lead, data access, hypothesis or retest authorization, root-cause review, product impact, CAPA, report approval, and closure rights are explicit.

The live case shows what the agreement requires for this product and service. Teams do not search a PDF while an escalation clock is running.

Manufacturing review, testing completion, deviation closure, CoA issuance, disposition recommendation, authorized-person certification, sponsor release, market release, and shipment authorization can belong to different parties.

Each decision retains prerequisite evidence, authority, signature, conditions, and handoff. One party cannot approve a step assigned to another simply because it hosts the system.

Batch records, raw data, audit trails, certificates, stability data, environmental monitoring, deviations, investigations, methods, validation, changes, annual reviews, complaints, and regulatory information can each have required format, completeness, transfer method, timing, review, and acceptance.

Receipt and acceptance are separate states. Missing metadata or an unreadable native file remains an open obligation.

Approved subcontractors retain service, site, qualification, sponsor consent, agreement, information flow, oversight, audit rights, records, changes, and termination. Delegation by one party does not erase the original party's responsibility.

A subcontractor change can identify every product, method, record, and regulatory commitment affected.

Intake, forwarding, investigation, sample returns, technical assessment, health-hazard input, regulatory reporting, recall decisions, customer communication, effectiveness checks, and final closure resolve to named parties and clocks.

The actual event retains the obligation version effective when it occurred, even if the agreement is later revised.

Audit schedule, scope, right of access, confidentiality, agenda, observations, responses, CAPA, evidence, due dates, verification, and closure connect to the services and obligations assessed.

Repeated findings can reveal an obligation that is poorly defined or a control that is not working across several products.

On-time records, right-first-time batches, OOS, deviations, notification timeliness, investigation cycle time, CAPA recurrence, release lead time, data completeness, stability performance, complaints, shortages, and audit findings use governed definitions and denominators.

Metrics remain linked to actual cases. A red score opens the evidence rather than ending the conversation.

Proposed changes show obligation-level differences, affected products and services, records, systems, procedures, training, contacts, open events, and implementation tasks. Both parties review and approve the same change set.

Open batches, samples, investigations, and changes are explicitly assigned to old or new terms. Signature alone does not make an agreement operational.

The review considers current scope, contacts, licenses, subcontractors, procedures, obligations, deviations, OOS, changes, release performance, data exchange, audits, CAPA, complaints, recalls, metrics, regulatory changes, and open commitments.

Differences between written responsibility and actual practice become actions, agreement changes, training, system changes, or service restrictions.

Final batches, samples, stability, complaints, recalls, retains, records, access, archival, transfer, destruction, equipment or materials, regulatory commitments, and continuing confidentiality receive explicit disposition.

Ending the commercial service does not close quality obligations that survive it.

Each organization can retain its own QMS, LIMS, MES, DMS, and identity system. Seal supports controlled exchange, client-specific visibility, verified copies, source links, and decision handoffs without pretending every partner will consolidate systems.

Where both parties operate in Seal, tenant and permission boundaries preserve segregation while shared objects expose only the agreed evidence and actions.

Seal is strongest at converting a negotiated responsibility into operational behavior. Because obligations resolve against real products, batches, samples, changes, events, and decisions, the agreement actively routes work and proves compliance.

A contract repository can store signed PDFs. A supplier scorecard can summarize performance. Seal's advantage is showing whether each promised control actually happened, on time, with the right evidence and accountable party.

The first implementation should follow one sponsor product through material sourcing, contract manufacture, external testing, deviation, change notification, record transfer, CoA, manufacturing review, sponsor disposition, shipment, performance reporting, and periodic agreement review.

Include a late notification, missing raw-data metadata, disputed investigation conclusion, retest authorization, subcontracted assay, open CAPA, contact change, conditional release handoff, complaint after shipment, and agreement revision. The first usable release must route one outsourced batch through every agreed clock and evidence handoff, surface any uncovered subcontractor before work begins, and leave no decision dependent on interpreting responsibility from memory.