Configure the process once. Take it to the next site.

Carry the process into a receiving-site draft. Ask Neil to compare the local plan, identify the differences and prepare the work to resolve them.

Bring your process
Illustration of a seal linking a small process vessel to a larger vessel through a shared technical drawing.

Summary

The problem
A process that already exists as structured records is turned back into documents, sent to the receiving site and re-authored there. Hold limits, working volumes and method revisions that differ between sites surface late, or only after a batch.
Seal’s approach
The receiving site starts from a permitted copy of the configured process as a separate draft. Neil compares the source and receiving records and prepares a gap assessment in which each finding points to its source version, the missing evidence and the proposed work.
What changes
Differences become owned questions for the process owner, engineering and analytical teams rather than lines in a document review. A later source revision prompts review of affected receiving configurations instead of silently replacing earlier decisions.
Where to start
One process, one receiving-site proposal and one transfer question, with an agreed output such as a gap assessment. Book a demo.

Carry the configured process to the next site.

Start the receiving site from a permitted copy of the configured process, held as a separate draft. In this fictional example, Neil compares it with the Site B plan and turns each difference into work for the team that owns it.

Why teams choose Seal for tech transfer

Tech transfer is traditionally a document package of process descriptions, batch records and reports that the receiving site reads and re-enters into its own MES and LIMS, with the gaps found during engineering runs. In Seal the receiving site starts from a copy of the configured process itself where the receiving site uses Seal; otherwise it works from the structured comparison. Each site difference becomes owned work with its own verification and approval. The receiving team gets a process it can execute, and the sending site’s evidence stays attached.

You: Take PROC-014 to Site B. Show me what needs to change.

Neil: I’d keep the process definition intact and work through these three Site B differences.

Site B / transfer draft

Example draft

Keep the process together.

PROC-014 / v04

  1. Mix
  2. Record the hold
  3. Transfer
Inspect inherited configuration
Hold limit
45 min
Method reference
AM-014 v04
Fields
Mix complete; Transfer started; Hold duration
Calculation
Transfer started − Mix complete
Completed sign-offs
0—separate, unsigned draft

Assess the local differences.

Hold durationSource: 45 minSite B plan: 60 min

Confirm the time definitions and review the receiving schedule against the source hold study. Resolve the schedule or assess a proposed change; do not silently extend the limit.

Proposed owner: Process owner

Equipment and scaleSource: 500 LSite B plan: 2,000 L

Compare vessel geometry, mixing and transfer arrangements against the process needs. Define the equipment assessment and any studies needed to support the receiving configuration.

Proposed owner: Receiving-site engineering / MSAT

Analytical methodSource: AM-014 v04Site B plan: AM-014 v03

Obtain both method versions and their change history. Assess the revision difference and agree the applicable method, transfer work and training before use.

Proposed owner: Analytical development / receiving QC

All three need assessment. The source limit stays unchanged.

Prepare a transfer work plan
Neil

I’d start with these three workstreams. Each has a proposed owner, the evidence to obtain and a decision to resolve.

Resolve the hold schedule

Process owner

Assess the receiving equipment

Receiving-site engineering / MSAT

Confirm the method revision

Analytical development / receiving QC

Site B / transfer work plan

Draft v01 / all three issues open

Compare PROC-014 v04 with SITE-B-014 v01. These excerpts establish the differences below, not the receiving site’s readiness or the complete transfer scope.

Hold duration

Proposed work: Resolve the hold schedule

The proposed 60-minute hold exceeds the source limit by 15 minutes.

Confirm the time definitions and review the receiving schedule against the source hold study. Resolve the schedule or assess a proposed change; do not silently extend the limit.

Proposed owner: Process owner

Evidence needed: A reconciled schedule and reviewed hold assessment, with any required change linked.

Equipment and scale

Proposed work: Assess the receiving equipment

Working volume changes from 500 L to 2,000 L. Comparable performance is not established.

Compare vessel geometry, mixing and transfer arrangements against the process needs. Define the equipment assessment and any studies needed to support the receiving configuration.

Proposed owner: Receiving-site engineering / MSAT

Evidence needed: A reviewed equipment comparison and the agreed supporting study results.

Analytical method

Proposed work: Confirm the method revision

The receiving plan names AM-014 v03; the source process names v04.

Obtain both method versions and their change history. Assess the revision difference and agree the applicable method, transfer work and training before use.

Proposed owner: Analytical development / receiving QC

Evidence needed: A method revision-impact assessment and the required method-transfer evidence.

Decision still needed

The responsible transfer team must assess these findings and define the remaining scope, studies and acceptance criteria. No equipment equivalence, method suitability, process change or transfer approval is established by this draft.

Fictional source excerpts and prewritten replies for this walkthrough. No live query or transfer approval.

Hand the receiving site a working record.

The receiving team has to run the process, so the handover should be something it can execute. Example batch B-041 in Seal runs a post-mix hold with the same 45-minute limit as PROC-014. The instruction, the recorded mix, hold and transfer times, the lab sample and the investigation into an extended hold all sit on one batch record.

Explore batch execution
Seal batch record B-041 showing hold instructions, recorded readings and linked lab sample and investigation. Example records, separate from the transfer preview.

Start with the records both sites already have.

Neither site has to replace its systems to begin. Connect permitted sources or supply the relevant records, then agree what Neil should compare.

The source process →

  • Procedure and process version
  • Development studies and parameter rationale
  • Method versions and material requirements

The receiving-site proposal →

  • Equipment and facility information
  • Proposed schedule and batch instructions
  • Local methods, training and open questions
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When the process changes, keep the earlier decision.

Each gap assessment names the source version it compared: PROC-014 v04 in this example. When the source is revised, the team reviews the revision against each receiving configuration and its open work. The earlier assessment and its decisions stay on record, and nothing at the receiving site becomes effective until it has been reviewed.

Follow a change through Seal

AQuestions and answers

What carries forward with a process copy?

A duplicate can retain document content, fields, field configuration, referenced records and coupled rows. It starts as a separate draft; checkpoint completions are not copied. Destination systems and referenced records must be accessible under the configured system permissions. Review site-specific assignments, values and dependencies before use.

Is the site-draft preview a live transfer?

No. The preview uses fixed example records. It illustrates carrying a process definition into a separate draft, followed by assessment of local differences. In Seal, duplication is available for permitted destination systems; it does not approve equipment equivalence, validation or site readiness.

Can we start with existing documents?

Yes. Start with the source process, receiving-site proposal and supporting records. Neil can draft a structured comparison from supplied files or connected, permitted sources. Your team checks the extracted values, versions and references before using the assessment.

Do both sites need to run on Seal?

No. Agree which records come from each site and which system remains authoritative. Connections depend on the source API, access and configuration; supplied records can also be used. A connected source is not permission to change the receiving MES, LIMS or QMS.

Does a completed checklist mean the transfer is approved?

No. The transfer team defines the scope, acceptance criteria, required studies and approvals. Closed actions are evidence for that decision, not a substitute for scientific assessment, qualification, validation or required regulatory work.

What happens when the source process changes?

Keep the prior version and assessment. Compare the revision against each receiving site’s configuration, identify the affected work and route proposed updates for review. A source change does not automatically make a receiving-site process effective.

Can this support sponsor and CDMO teams?

Yes. Define responsibilities, permitted records and review access for each party. Keep technical questions, evidence requests and decisions together without assuming every participant can see every source.

What should we bring to a first evaluation?

Bring one transfer question, the relevant source version and the receiving-site plan. Agree an output such as a gap assessment or evidence-request package, then check whether its findings are supported and its follow-up work is useful.

Your next site should not start from scratch.

Bring one process and a receiving-site proposal. See what carries forward, inspect the local differences and review the work needed to put the receiving configuration into use.

Bring your process