Summary
- The problem
- An instrument produces files, but the lab needs a result, manufacturing needs the batch it informs and quality needs the evidence behind the decision. A finished PDF on a share does not show whether the raw data, method, sequence and audit trail arrived.
- Seal’s approach
- Seal IoT watches a chosen folder on the instrument workstation and uploads supported exports to a configured Seal record over outbound HTTPS. The original file stays attached to the sample, batch or investigation it supports.
- Neil
- Seal’s AI agent gathers the acquisitions behind a batch or investigation, compares reports and prepares capture changes with their verification. Your team reviews and decides. About Neil.
- What changes
- Reviewers reach the preserved acquisition from the result, and reprocessing creates a derived record rather than overwriting the earlier one. Format, parser and mapping changes follow change control with their own verification.
- Where to start
- One representative acquisition and the workflow it supports, evaluated with a late file, a duplicate transfer and a failed integrity check. Book a demo.
1A traditional SDMS archives the file. Seal connects it to the work.
A traditional SDMS is an archive for instrument files. It keeps them beside the work: the result, the batch it informs and the investigation that assesses it live in other systems and point back by filename, and a parser or mapping change is a project of its own. Yet the lab needs a result, manufacturing needs to know which batch it informs and quality needs the evidence behind the decision.
Seal captures the same files with Seal IoT and treats each acquisition as a record with relationships. In Figure 1, ACQ-1842 keeps its five original files and links to sample QC-1842, batch B-041 and investigation DEV-018, so a reviewer, an investigator and Neil reach the same preserved original from the work they are doing. That work runs in one platform, with the original scientific data still available to inspect. A revised format, parser or mapping goes through change control, and earlier files keep the interpretation they were reviewed under.
| A traditional SDMS | Seal | |
|---|---|---|
| Where files go | An archive beside the work | The sample, batch or investigation |
| Link to the work | A filename or a path | A relationship between records |
| Completeness | Files as they arrive | Required files, checked by role |
| Review | Across the archive and LIMS | From the result to its original |
| Reprocessing | A new file beside the old | A derived record, with its reason |
| Capture changes | A separate project | A changeset with its verification |
| Investigation | Evidence gathered by hand | Neil assembles it, with sources |
| Getting started | A migration project | One instrument, beside your systems |
You do not have to replace every system to start. Seal IoT collects the exports your instrument software already writes, from Waters Empower, Chromeleon and OpenLab CDS to the rest of the instrument directory. Connect the source needed for the first job, agree which system owns each record and verify the mapping. Review ambiguous matches rather than silently attaching a result to the wrong sample.
2Install Seal IoT. Connect the instruments you already use.
Seal IoT is the installable agent that connects local instrument output to Seal. It runs beside the instrument software, sends each file over outbound HTTPS and keeps the original as it was written.
Seal IoT on HPLC-04
- Folder
- D:\Exports\HPLC-04
- Subfolders
- Included
- Trigger
- New or changed file
- Sends when
- File size is stable
- Template
- Instrument acquisition
- Connection
- Outbound HTTPS, port 443
Run it on a Windows or macOS machine with access to the source files: an instrument workstation, a local staging machine or a host that can read the relevant network share.
Choose the folder, whether to include subfolders and which Seal template should receive the files. A file-watch trigger detects new or changed files, waits for file-size stability and runs a configurable script to upload the file as an attachment to a record. Different sources can use different triggers and templates.
This makes the connection adaptable to the laboratory. The vendor application continues to acquire the data; Seal IoT bridges its supported exports into the workflows your team runs in Seal. Preserving a proprietary file and interpreting its contents are separate capabilities. Agree and verify the required formats, extraction and mappings for each source.
2.1What IT needs to know
The documented folder-upload route needs no inbound connection to the workstation. Confirm the rest with IT before installation.
| What to confirm | |
|---|---|
| Host | Windows or macOS, with access to the files |
| Network | Outbound HTTPS on port 443 |
| Inbound ports | None for the folder-upload route |
| Folder access | Through the running account |
| Allowlist | seal.run, plus sign-in and update services |
| Credentials | Scoped to the destination workspace |
| Unattended use | A dedicated account and startup |
Test connectivity from the actual host before relying on it. Windows network shares use the running account’s permissions, so an unattended installation needs its own account and the host’s startup arrangement. Authentication and agent updates use service domains beyond seal.run; review the full allowlist, update behaviour and operating responsibilities before deployment.
2.2What happens when capture is interrupted
The agent exposes connection diagnostics, recent runs and errors. Upload scripts can retry transient failures. Startup capture can include files already present, so files that arrived while the agent was stopped can be picked up if they remain at the source.
That recovery needs an agreed source-retention window and reconciliation rules. A changed file can trigger another upload; the basic folder-to-record script does not deduplicate by filename. Define how acquisition identity, retries and changed content are handled before treating the connection as ready for use.
3Capture the acquisition, not just the report.
A chromatographic run may produce raw data, a method, a sequence, an audit trail and a report. Define the required file roles for the source: a finished PDF does not prove that the rest arrived.¹
- Raw data (met)sequence-1842.raw
- Method (met)assay-method-v08.xml
- Sequence (met)sequence-1842.csv
- Report (met)report-1842.pdf
- Audit trail (not met)Not received
A chromatographic record is dynamic: the baseline can be changed and the data reprocessed. A printout or static report does not preserve that format, so it cannot stand in for the original.²
Configure capture around the supported interface: an export, watched location or API. Account for files still being written, late companion files, duplicate transfers and interrupted connections. A missing file and, where a checksum check is configured, a checksum mismatch require different responses.
Preserve the original bytes and their source metadata.³ Record capture time separately from acquisition time, and keep the source identity behind any normalised timestamp. Extracted values carry their parser and version so reviewers can trace them back to the file.
- Source
- HPLC-04 workstation
- Acquired
- 18:42, instrument clock
- Captured
- 18:43, by Seal IoT
- Integrity
- Size and checksum kept
- Values
- Extracted by parser v3
4One platform from acquisition to investigation.
Scientific data sits alongside lab workflows, electronic lab notebooks, manufacturing and quality management in Seal. The acquisition links to a sample; the sample links to a batch; an investigation points to the evidence it assesses.
- Batch
- B-041
- Sample
- QC-1842, assay
- Report
- REPORT-1842 v02, derived
- Original
- ACQ-1842, five files
- Review
- SDR-1842, open
Those relationships give people and Neil a common context. They distinguish an original file from a processed result, an approved report from a draft and a complete package from one still waiting for review.
5A new result must not erase the old one.
Reprocessing, reintegration and report generation create derived records. Keep the input objects, method and software version, changed parameters, reason and output together.
- Source
- ACQ-1842
- Processing
- Method v08
- Reason
- First processing
- Review
- Kept
- Source
- ACQ-1842
- Processing
- Reintegrated
- Reason
- Peak 3 shoulder
- Review
- Open
Reviewers should be able to compare the earlier result with the new one and reach the same preserved acquisition from either.⁴ Saving only the final result of reprocessed chromatography is not enough: each result is retained for review.⁵
Review covers the source evidence and the changes, not only the final number. Findings, responses and required signatures belong to the package being assessed.
6Neil prepares the work. Your team decides.
Neil is Seal’s AI agent. Ask which acquisitions support a batch, what changed between two reports or where an investigation is missing evidence. Neil follows the records the requester is permitted to see, connects the findings and prepares the next step as work in Seal; your team inspects the sources and reviews the conclusion.
| Neil prepares | Your team decides | |
|---|---|---|
| Batch evidence | The acquisitions behind a result | Whether the evidence is enough |
| Investigation | The evidence, with its sources | Cause and impact |
| Reprocessing | What changed between two reports | Whether the change is justified |
| Capture set-up | The template and its checks | Whether they match the source |
| Format change | A changeset with its verification | Approval and release |
Which acquisitions support the B-041 assay, and is any evidence missing?
Neil
- ACQ-1842 on HPLC-04, for sample QC-1842.
- All five files received; the audit trail arrived late.
- REPORT-1842 v02 reintegrated peak 3; v01 is kept.
- HPLC-04’s clock ran two minutes ahead of Seal’s.
- Evidence (met)Assembled, with sources
- Reintegration (not met)For the reviewer
- Impact (not met)For the investigator
That starts with usable context: the sample, instrument, method, acquisition and version. Unsupported formats, missing records and unresolved matches remain visible rather than becoming confident guesses. Neil can assist an investigation, but it does not turn receipt of a file into approval of a result.
Nothing Neil produces takes effect on its own. Neil stages changes for review; authorised people check a capture configuration against the source, run the required verification, sign and publish the change, and approve results. Existing acquisitions keep the configuration they were captured under.
In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution. It helps set up configuration, which your team verifies and releases under change control. See how Neil fits Annex 22 and more about Neil.
7Evolve the connection under change control.
A software upgrade can change a file format. A new method can add a companion file. A parser update can change an extracted value. Treat these as controlled configuration changes, with affected requirements, specifications and verification linked to the version that will enter use.⁶
- Software
- Version 7.1
- Parser
- Version 3
- Verification
- Complete
- Used by
- ACQ-1842
- Software
- Version 7.2
- Parser
- Version 4
- Verification
- In progress
- Used by
- Nothing yet
Seal’s continuous validation approach keeps that work in the platform. Verify representative inputs and failure cases, review the impact and approve the change. Keep existing records connected to the configuration and processing history that produced them.
For a Seal IoT connection, the change scope includes the agent version, trigger script, source path, destination template and metadata mappings. Keep the relevant user requirements, functional and design specifications, configuration specification and verification evidence linked to the change. Neil can assemble them in a changeset with the revised configuration and verification cases. Repeat the affected checks when the configuration changes; investigate exceptions before release. Installation alone does not validate the end-to-end workflow.
8Retrieve the evidence when it matters.
Query by the work you recognise: sample, batch, method, instrument or investigation. Confirm why a record matched and whether it is the original, a derived result or a report. Access permissions still apply to queries, Neil and export.
Retention is specific to the record and its governing policy—not a universal number of years. Define the start event, policy version, holds and disposition authority. Test restore and readability with the required files and applications; storing a binary is not the same as being able to review it later.
- Retention (met)From batch release, policy v3
- Restore test (met)Recovered and readable
- Hold (not met)HOLD-DI-017, active
- Disposition (not met)Blocked by the hold
For an inspection or migration, keep the selected objects, manifest, identity mapping and verification evidence together. Clearly distinguish a migrated rendition from a native original.
9Prove one source before expanding.
Bring one representative acquisition and the question or workflow it needs to support. Confirm the vendor interface, file formats, required companions, ownership and review expectations. Start with a sample, or arrange an NDA before sharing confidential records.
Include a late file, a duplicate transfer, a clock discrepancy and a failed integrity check in the evaluation. Demonstrate the path from capture to retrieval, including what happens when the expected evidence is absent. Then extend the pattern to the next instrument or laboratory. To scope that first source with us, book a demo.
References
- 121 CFR 211.194(a)(4), Laboratory records: a complete record of all data secured in the course of each test, including all graphs, charts and spectra from laboratory instrumentation, identified to show the material and lot tested. eCFR
- 2FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, guidance for industry (2018), questions 1.d and 10: a dynamic chromatographic record lets the user change the baseline and reprocess the data, and a printout or static record does not preserve the dynamic format that is part of the complete original record. FDA
- 3FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, guidance for industry (2018): complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). FDA
- 4EudraLex Volume 4, Part I, Chapter 4, Documentation (2011), sections 4.8 to 4.10: records should be made at the time each action is taken, alterations should be signed and dated and permit reading of the original information, and secure controls must ensure record integrity throughout the retention period. European Commission
- 5FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, guidance for industry (2018), question 14: if chromatography is reprocessed, written procedures must be followed and each result retained for review; saving only the final results is not acceptable. FDA
- 6EudraLex Volume 4, Annex 11, Computerised Systems (2011), sections 4 (validation) and 10 (change and configuration management). European Commission
AConnected across Seal
BConnected records
CQuestions and answers
What is an SDMS, and how is it different from a LIMS?
An SDMS manages scientific files and their provenance: acquisition, capture, processing, review and retention. A LIMS manages laboratory work such as samples, tests and results. Seal connects both in one platform, so the result stays linked to its original instrument evidence.
How is Seal different from a traditional SDMS?
A traditional SDMS archives instrument files beside the work, and the result, batch and investigation point back to them by filename. Seal captures the original files with Seal IoT and links each acquisition to the sample, batch and investigation it supports. Reprocessing creates derived records, and capture changes are released under change control. You can start with one instrument alongside the systems you run.
Which instruments and file formats can we connect?
Support depends on the vendor, software version, available export or API and required file roles. We assess a representative acquisition before agreeing the connection. Preserving a proprietary binary does not imply that Seal or Neil can interpret it; metadata extraction and readable renditions must be verified for that format.
Where is Seal IoT installed?
On a Windows or macOS host with access to the instrument output. This may be the workstation, a staging machine or a host with access to a network share. The running account needs the relevant folder permissions. The agent’s folder triggers and scripts connect files to records in Seal.
Does each instrument need an agent or an inbound connection?
Not necessarily. One host can run multiple folder triggers if its account can access the relevant sources. The documented folder-upload route uses outbound HTTPS without inbound ports. Agree network boundaries and source access with IT; include authentication and update services in the outbound allowlist, not just seal.run.
What happens while the Seal IoT agent is offline?
Files must remain available at the source. The agent can be configured to process files already present when it starts, and upload scripts can retry transient failures. The basic folder-to-record script does not deduplicate by filename, so agree the source-retention window and configure and verify how missed, repeated and changed files are reconciled.
What happens if a file is late, incomplete or duplicated?
The capture rule defines expected file roles and how writing completion is detected. A package remains incomplete while required evidence is missing. Retries must preserve acquisition identity; conflicts found by a configured checksum check, and duplicates, need explicit reconciliation. The evaluation should demonstrate each case on the proposed interface.
Is a PDF report enough?
A report can be useful for review, but may not include the native acquisition, sequence, method, processing parameters or audit trail. Define the evidence required for the intended use and retain those objects with their roles. Do not present a rendition as the native original.
Can Neil investigate the scientific data?
Neil can work with accessible records and supported representations: find related acquisitions, compare recorded metadata and help assemble evidence for an investigation. Missing files, unsupported formats and uncertain matches must remain explicit. Your team evaluates the findings and controls decisions and release.
What happens when a result is reprocessed?
Keep the original acquisition and create a related derived record. Retain the inputs, method, parameters, application version, operator, time and reason, along with the output and its review. Earlier results remain available; a later report does not erase the processing history.
How do parser and instrument-software changes stay controlled?
Assess the affected formats, fields, mappings and downstream workflows. Update the configuration and its specifications, then verify representative acquisitions and failure cases. Retain results and approvals against the changed version. Existing records keep their original provenance and processing history.
How long is data retained, and can it be restored?
Agree retention by record class, governing event and applicable policy, and track active holds separately from retention dates. No single retention period suits each acquisition. A restore test should recover the required objects, verify integrity and show that they are readable with the necessary applications.
Can existing archives be migrated?
Scope the source inventory, native files, renditions and missing evidence first. Verify identity mappings, file integrity and sample or batch relationships, and retain exceptions and migration evidence. Label a legacy PDF as a rendition when the native source is unavailable; do not imply that the missing original was recovered.
What do we need for a first evaluation?
One representative acquisition, its source software and interface, the expected file set and a question or workflow to support. Agree owners, access, review and retention needs. Test late and duplicate files, interrupted transfers, integrity exceptions and retrieval before expanding to more sources.
