Seal vs Dot Compliance

1Dot Compliance and Seal, side by side.

Dot Compliance and Seal both serve regulated life sciences teams, and both now put AI agents to work on quality records. They begin in different places. Dot Compliance supplies an eQMS whose processes arrive pre-configured with industry practice and pre-validated, on the Salesforce platform, so a team can adopt them quickly.¹ In Seal, teams configure laboratory, manufacturing and quality workflows on one platform around a shared ontology, so the result, the sample and the batch behind a quality decision are records in the same system.

2What Dot Compliance is built for.

Dot Compliance is built for life sciences companies that want a complete eQMS running quickly, without designing each process from the beginning. Dot Compliance Ltd. says it has supported life sciences companies since 2015 and has more than 500 customers in 30 countries; its founder, Doron Sitbon, is chief executive.² It serves pharmaceutical, biotechnology, medical device and cosmetics companies.¹

The eQMS comes with dozens of pre-built modules and pre-validated packages, configured with industry best practice.³ Its processes cover document, training, change, complaint, quality event, CAPA, supplier quality, audit, equipment and risk management, with an electronic batch record solution,¹ and its Salesforce page adds regulatory management.⁴ Dot Compliance runs natively on Salesforce, and customers do not need a separate Salesforce licence.¹ Its validation documentation package is made available to every customer as part of the subscription, and its electronic signatures capture the signature’s meaning and link it to the record through a time-stamped audit trail.⁴

Two further areas reach beyond the quality department. Dot’s clinical management combines a clinical trial management system with the eQMS, including a trial master file kept to the DIA TMF reference model, submissions to institutional review boards and clinical quality events.⁵ Its EBR solution is described as integrating the eQMS with MES and connecting with LIMS and ERP.⁶

AI is central to how Dot presents the product. Its AI layer, Dottie, includes a Research Agent that works across internal records and trusted external sources, a Review Agent that looks for gaps and compliance issues, and Document to Protocol, which turns approved documentation into structured protocol content.⁷ Dottie AI 5.0, released in April 2026, introduced agent personas.⁸

3How an out-of-specification result reaches its investigation.

Both products can record a laboratory failure as an event, investigate it and escalate it to a CAPA. The difference is whether the result is a record in the same system or evidence brought to it.

In Dot Compliance, quality event management covers nonconformances, deviations and incidents that could affect the quality or reliability of records or tests, with guided investigation and root cause analysis. Users attach supporting evidence such as photographs, lab results or data logs to the event; classify it as minor, major or critical, which sets its approval path and response times; link it to supplier or equipment records; and promote it to a CAPA when it needs a systemic fix.⁹

In Seal, the investigation opens from the result itself, with the sample, raw data, method, instrument and batch history already linked. In the example in Seal’s OOS and OOT investigation blueprint, an assay result of 92.1% for batch TX-410 remains the original, permanent result through an inconclusive Phase I. The full investigation tests a solution-stability hypothesis and runs a retest plan, both approved before any result is known, and scopes eight batches before concluding that there is no assignable cause. TX-410 is rejected, and a CAPA opens with a monitoring cohort.

Three things follow from keeping that on one record. A reviewer can see which result came first, who authorised each further test and why, because retests and hypothesis tests are planned steps on the investigation rather than entries in an analyst’s notes. No later passing result replaces the original failure. And closing a laboratory task cannot release material: batch disposition is a separate decision with its own evidence and signature. Where an investigation points to a weakness in a method, the corrected method version governs the next analysis, instead of a revised document waiting to be implemented.

In an evaluation, take one failing result through an inconclusive Phase I and a retest, then ask where the original value, the retest plan and its approval are recorded.

4How each puts AI to work.

Both vendors keep people in the approval path. Dottie’s agents act as defined roles across the quality record; Neil’s output is configuration and prepared work that your team verifies and releases.

Dot describes a shift for quality teams from configuring software features to hiring digital personas. Organisations use predefined agents or create new ones with a defined domain, job description, duties, skills, training materials and boundaries; agents can work proactively and pause for expert approval before critical steps move on. Authorised quality managers coach an agent by giving feedback on its responses, and Dot says each insight stays tied to its source documents and verified regulatory records.⁷

Neil, Seal’s AI agent, works across your records and connected systems within the permissions of the person asking. Given a procedure, it proposes a working process in Seal: the record structure, fields, steps, roles and review gates. For an investigation it gathers similar events and their source records and drafts a summary in which a likely cause stays a hypothesis; for an improvement it drafts the changeset with its verification cases. People test and approve every change, Neil does not release one itself, and AI can be switched off for the whole organisation. Under Seal’s agreements, customer data is not used to train AI models. 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.

5Where Dot Compliance is the better fit.

Dot Compliance is the better fit when you want a complete, pre-validated eQMS in place quickly, with AI agents across it.

• You want quality processes pre-configured with industry practice and live fast, with the vendor’s validation package included in the subscription.³⁴
• You run clinical trials and want trial management, a trial master file and clinical quality events beside your eQMS.⁵
• Your IT strategy favours the Salesforce platform, and you want an eQMS that runs natively on it.⁴
• You want AI agents defined like members of the team, with duties, skills and boundaries, working across your quality records.⁷
• You make medical devices or cosmetics as well as drugs and want one eQMS across them.¹

6Where Seal is the better fit.

Seal is the better fit when quality decisions depend on laboratory and manufacturing records and you want those records in the same system.

• Your investigations start from laboratory results. In Seal’s shared ontology a sample belongs to a batch and a result comes from a test, so an investigation links to all three rather than to copies of them.
• You want additional testing planned and approved on the investigation before results are known, with the original value kept.
• You want a corrective action released as a change to the workflow itself, such as a calculation, a limit or a required check, with its effectiveness measured on the work that follows.
• You want each change to carry its own evidence. Requirements and specifications stay linked to the configuration, selected user acceptance tests run when a changeset is prepared for review, and publication requires current passing results. Earlier runs keep the process version they used.

7Running Seal alongside Dot Compliance.

You can keep Dot Compliance for documents, training and quality events while one laboratory or quality process runs in Seal. Seal has no dedicated Dot Compliance connector. Systems that are not on Seal’s integrations list connect through Seal’s REST API and Scripts, and Seal can review their interfaces with you.

The API lets another system, or your own application, read and write Seal records under credentials, transfer direction and failure handling agreed in advance. Scripts, written in versioned Python, can check data, update several records or call an external service when an event occurs or on a schedule; each is changed through a changeset and tested before it is published. Dot Compliance says it integrates with ERP and other systems through the Salesforce platform.¹ If your environment gives API access to its records, Seal’s Salesforce connection can also reference selected Salesforce records, including queryable custom objects; that connection only reads.

Begin by reading, and qualify the connection with the checks in the regulatory guide: source identifiers, field mappings, missing, late and duplicate records, and reconciliation against the source. Any write-back to Dot Compliance is a separate decision with its own actions and review. Dot Compliance can then remain the home of procedures, training and supplier records while OOS investigations run in Seal and reference the records they need.

8Moving from Dot Compliance to Seal.

Move one process first; Dot Compliance stays the record for everything else.

1. Pick a process whose evidence lives in the laboratory, such as a release test with repeated OOS or invalid results.
2. Bring the procedure, one representative investigation and the records it touches: the result, its raw data, the method version and the batch. Start with sample material, or arrange an NDA before sharing your own.
3. Neil proposes the workflow from the procedure, including the Phase I checklist, the retest plan and its approval, and the impact scope. Once the evaluation scope is agreed and the required inputs are received, Seal prepares the first working process and its supporting validation pack within 48 hours. The pack includes source traceability, recorded test results and configuration history; production release follows your intended-use assessment and quality controls.
4. Exercise the hard paths before release: a clear calculation error, a passing retest after an OOS result, and an attempt to close the investigation while the batch decision is open.
5. Agree which records move and which stay retrievable in Dot Compliance. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled before you rely on the new workflow.

Retention obligations continue for the records that remain in Dot Compliance. The LIMS and QMS blueprints describe the laboratory and quality workflows in more detail.