CDMO Manufacturing and Quality Management Software

Summary

The problem: Answering a sponsor’s campaign question means collecting execution, laboratory and quality records from several systems and deciding by hand what can be shared.
Seal’s approach: Campaign execution, results and quality work are recorded against the same campaigns and batches, so a sponsor question does not start with collecting records from ERP, MES, LIMS and QMS. neil can prepare a sponsor update or transfer package from records your team can inspect, and sponsor access follows configured project and record permissions.
What changes: A review package is assembled from selected evidence while disposition stays an authorised decision, and preparing an update stays separate from approving and sending it.
Where to start: One sponsor question and a small campaign, including a late result, a missing raw-data reference and an internal record that must not be shared. Book a demo.

Put one question to the records.

Prepare Aster’s campaign update. Which batches are on track, what is holding the package up, and what can we share with the sponsor?

neil

B-081 has completed manufacturing and QC testing, but its review package is still missing a raw-data reference. B-082 is in QC; B-083 is in manufacturing. I’ll keep the sponsor’s draft separate from internal review notes.

Aster’s campaign, as it stands

ManufacturingQC testingPackage review

B-081

Awaiting raw-data reference

B-082

QC testing in progress

B-083

Manufacturing in progress

Position in the workflow, not a time forecast. No release decisions are recorded.

“Testing complete” and “package ready” are different milestones. The update should explain the remaining work.

About this example

A prepared conversation using fictional records, not a live query. Source buttons open the example evidence. The draft can be read and downloaded; no records are changed, shared or approved.

Answer the sponsor from the evidence.

Connect campaign execution, laboratory results, quality events and agreed deliverables. neil can turn the selected records into a sponsor update, a review brief or a transfer-gap assessment.

Existing ERP, LIMS and QMS systems can remain authoritative. Scope each connection to the permitted project and record set. Keep source times and versions with the answer, so an update can be checked against the actual evidence rather than a copied status that has lost its context.

Why teams choose Seal for contract manufacturing.

At many CDMOs, a sponsor update or batch package is assembled by hand from the ERP, MES, LIMS and QMS that ran the client’s campaign. Seal keeps campaign execution, laboratory results, quality events and agreed deliverables on one record, with each sponsor’s exchange scope configured on it.

Sponsor updates and review packages are prepared from the records themselves, and a client-specific process is configured on shared operations as a versioned, approved change rather than a new implementation project.

Configure the client-specific work around shared operations.

Use Seal to connect the client’s process, your execution templates, equipment, samples and review requirements. neil can draft the process configuration from supplied procedures for your team to verify.

A shared room does not imply shared sponsor access. Define roles, project boundaries, approved exchange content and decision rights explicitly. Test those boundaries with permitted and denied records before opening a client view. Configure campaign changeovers and evidence checks for the actual facility and process.

Make the handover inspectable.

A transfer needs more than a set of files: it needs the selected process version, site adaptations, unresolved gaps and evidence that the receiving team can carry out the work.

Start with one sponsor and one campaign. Follow a changed method, a late result and an internal note that must not be shared. Verify that the resulting work package keeps its sources, separates planned dates from commitments and reaches the right reviewer before anything is sent.

What the blueprint configures.

Explore the configured capabilities

Sponsor-scoped access

Configure project and role permissions for the client relationship. Verify both permitted and denied access before sharing records.

Technology transfer

Ask neil to extract the proposed process from supplied documents and prepare the gaps and changes for technical review.

Sponsor exchange

Prepare the selected status and evidence package, then route it through the agreed sharing review.

Campaign management

Connect the client process, equipment allocation, changeover evidence and batch execution.

Batch-review preparation

Bring together execution, laboratory and quality evidence. Keep missing source records and open review work visible.

Shared equipment

Allocate common equipment and rooms across projects while preserving the agreed sponsor-access boundaries.

Client-specific workflows

Configure the required records and review paths for each project on shared platform capabilities. Test the actual process before use.

Explore the connected records

Continue into the connected work.

AQuestions and answers

Can sponsors see their own records?

Configure the sponsor’s permitted projects, record types and actions. Test access with the intended roles, including denied records and shared-resource references. Sharing scope and review requirements should follow the client relationship and applicable agreements.

Do we need to replace our ERP, LIMS or QMS?

No. Start with the records needed for one campaign or sponsor deliverable. A scoped connection can preserve the existing system as the source while linking its evidence to review and follow-up in Seal.

What does neil do during technology transfer?

It can extract proposed parameters and records from supplied procedures, compare source versions and draft the receiving workflow or gap assessment. Process owners review the interpretation, resolve ambiguities and verify the configured work.

Can neil send the sponsor update automatically?

This example only prepares a draft. Any operational distribution workflow needs an agreed audience, source scope, permissions and review requirements. Preparing a report is separate from authorising and sending it.

How is a review package different from release?

A package assembles the selected execution, testing and quality evidence. Reviewers still assess completeness and suitability, and authorised people record disposition. A completed test or generated report is not a batch-release decision.

What should we use for the first proof?

Choose one sponsor question and a small campaign. Include a late result, a missing raw-data reference and an internal record that must not be shared. Verify the draft, its source selection, the follow-up work and the audience boundaries.

Run the campaign. Keep the sponsor in the picture.