Quality agreements.

1A quality agreement governs the work after signature.

A quality agreement sets the operating boundary between the parties: who performs, reviews, approves, notifies, investigates, supplies records, releases, retains, audits and escalates each regulated activity. Its value lies in how the work runs after signature, which a signed PDF in a contract repository cannot show.

Seal turns those responsibilities into obligations connected to actual products, sites, batches, samples, changes, deviations and decisions, so both parties can show that the agreed operating model is the one in use.

FDA’s quality agreements guidance for contract drug manufacturing is the primary US reference for defining and documenting each party’s manufacturing activities while preserving each party’s CGMP responsibilities. The owner’s quality unit remains responsible for approving or rejecting product made under contract.¹

2Structure responsibilities instead of burying them in prose.

Scope starts with the legal entities, sites, quality units, authorised contacts, products, markets, subcontractors and effective dates. Each regulated service (manufacturing, testing, release, storage, transport or complaint handling, for example) can be included independently. Commercial terms stay outside the quality workflow unless they create a regulated obligation.

Each activity then names the accountable party, performer, reviewer, approver, parties to notify, evidence provider, timing, governing procedure and escalation. The controlled narrative is generated from those obligations, so overlaps and unassigned activities are visible before approval. Applicability rules show which obligation governs each batch or sample when one relationship covers several products, methods and sites. A corporate template can supply defaults without treating an aseptic CDMO, a microbiology laboratory and a warehouse as if they needed the same controls.

2.1Why teams choose Seal for quality agreements

A contract repository stores the signed PDF, and the teams on both sides interpret it from memory while notification and investigation clocks run. Seal resolves each obligation against the batches, samples, changes and events it governs, so the agreement routes work and shows whether each promised control happened on time, with the right evidence and the accountable party. When the agreement is revised, open work is assigned to the old or new terms explicitly, rather than left to whoever remembers the change.

3Keep procedures, records and data exchange explicit.

The agreement identifies whose procedure governs, how differences are reconciled, who authors and approves each record, which system is authoritative, and how certified copies, retention and inspection support work. System access does not transfer accountability: each party keeps the signatures and decisions assigned to it.

Data exchange has content and timing requirements. Batch records, raw data, audit trails, certificates, stability data and investigations can each have a required format, completeness, transfer method and deadline. Receipt and acceptance are separate states, and missing metadata or an unreadable native file remains an open obligation.

4Make notifications and investigations follow the agreed rules.

A change to a process, material, method, specification, equipment, site or subcontractor can require pre-approval, prior notification, prompt notification or periodic reporting. Seal resolves the applicable obligation, required information, recipients, due clock and implementation conditions.

For deviations and OOS results, the agreement sets notification thresholds and timelines, containment, who leads the investigation, data access, retest authorisation, product impact, CAPA and report approval. Complaints, recalls and safety signals resolve to named parties and clocks in the same way. The live case shows what the agreement requires for this product and service, and each event keeps the obligation version in effect when it occurred, even if the agreement is later revised.

5Separate manufacture, certification and release.

Manufacturing review, testing, deviation closure, CoA issue, disposition recommendation, certification by a qualified or authorised person, sponsor release and shipment authorisation can belong to different parties.² Each decision keeps its prerequisite evidence, authority, signature, conditions and handoff. Hosting the system does not let one party approve a step assigned to another.

6Oversee subcontractors, audits and performance against the promised controls.

Approved subcontractors keep their service, site, qualification, sponsor consent, agreement, oversight and audit rights. Delegation by one party does not remove the original party’s responsibility, and a subcontractor change identifies the products, methods, records and commitments it affects.³

Audit scope, observations, responses and CAPA 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. Performance measures, such as notification timeliness, on-time records, investigation cycle time and data completeness, use defined denominators and stay linked to actual cases. A poor score opens the evidence rather than ending the conversation.

7Revise, review and terminate with the operations in view.

A proposed revision shows obligation-level differences and the affected products, records, systems, procedures, training, contacts and open events. Both parties review and approve the same change. Open batches, samples, investigations and changes are explicitly assigned to the old or new terms; signature alone does not make an agreement operational.

Periodic review compares the written responsibilities with actual practice: deviations, changes, release performance, data exchange, audits and open commitments. Differences become actions, agreement changes, training, system changes or service restrictions. At termination, final batches, retained samples, stability, complaints, records and regulatory commitments receive an explicit disposition. Ending the commercial service does not close the quality obligations that survive it.

Each organisation can keep its own QMS, LIMS, MES, DMS and identity system. Seal supports controlled exchange, client-specific visibility, verified copies, source links and decision handoffs. Where both parties use Seal, tenant and permission boundaries keep them separate while shared records expose only the agreed evidence and actions.

8Prove one outsourced batch end to end.

Start with one sponsor product and follow it through material sourcing, contract manufacture, external testing, a deviation, a change notification, record transfer, CoA, sponsor disposition, shipment and periodic review.

Include the difficult cases: a late notification, missing raw-data metadata, a disputed investigation conclusion, retest authorisation, a subcontracted assay and an agreement revision. The first release should route the batch through every agreed clock and handoff, surface any uncovered subcontractor before work begins and leave no decision dependent on remembering who is responsible.