Seal vs Ideagen Quality Management (Q-Pulse)

1Ideagen Quality Management and Seal, side by side.

Ideagen Quality Management, the system long known as Q-Pulse, and Seal both keep audits, findings and corrective actions connected, and both are used in regulated work. Ideagen Quality Management is a quality management system used across healthcare, pharmaceuticals, medical devices and manufacturing, from a vendor that also sells EHS, risk and compliance software.¹² In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so an audit can open the records of the work themselves, at the version it selected.

2What Ideagen Quality Management is built for.

Ideagen Quality Management is built for organisations in many regulated industries that want document control, CAPA, audits, training and supplier quality in one system, beside EHS and risk software from the same vendor. Q-Pulse was the name of one of Ideagen’s quality management products. Ideagen now calls it Ideagen Quality Management, part of a broader quality solution under that name, and says the product itself is unchanged.¹³ On the UK government’s G-Cloud marketplace, the edition is listed as Ideagen Quality Management Professional (formerly Q-Pulse).⁴ In June 2022, Ideagen plc’s shareholders approved its acquisition by a company wholly owned by funds managed by Hg, the software investor,⁵ and that October Hg said it would remain the majority investor when Ideagen combined with ProcessMAP, an EHS software provider.⁶

The quality management system covers document control, CAPA, audits, inspection, training and competency, supplier quality and regulatory intelligence, with ISO 9001 including the 2026 edition, ISO 13485, 21 CFR Part 11, AS9100, IATF 16949 and ISO 17025 built into its workflows.² The Professional edition also covers incident reporting, asset and equipment maintenance, customer complaints, and risk with bowtie analysis, and runs as a Windows client, an HTML5 web client and mobile apps.⁴ Ideagen describes mobile-first smart forms with offline data capture for distributed teams.⁷

Ideagen’s customer examples include Torbay Pharmaceuticals, which centralised CAPA, calibration, training and EU GMP compliance across three sites, and NHS and Nuffield Health pathology services working to ISO 9001 and ISO 15189. Ideagen Hub connects quality with EHS, compliance and risk on the same data and audit trail.²

Its AI, Ideagen Mazlan, is embedded in audit, incident, risk and quality workflows. It drafts root cause analyses, prepares audit evidence and audit responses, and assigns and tracks corrective actions. Ideagen says every Mazlan output, from a root cause suggestion to a drafted report, requires human review and approval.⁸²

3How an audit finding reaches the work.

Both products link an audit finding to the action it needs. The difference is what the audit evidence is, and what closes the finding.

In Ideagen Quality Management, auditors work through structured digital checklists, on mobile where needed, with scheduling and workload management across concurrent audits. Workflows trigger an integrated CAPA as soon as a finding is documented, against standards and regulators such as ISO 9001, UKAS and the MHRA.⁹ The CAPA application guides investigations, tracks implementation on dashboards with alerts for overdue actions, verifies effectiveness through statistical process control and correlates incidents by root cause, product line, supplier or process step.¹⁰

In Seal, the evidence is the record itself. In the example in Seal’s audit blueprint, internal audit AUD-014 samples batch reviews B-041, B-044 and B-047 into evidence package PKG-014. The package keeps B-041 and B-044 at the version selected, v1, although B-041 has since been revised to v3; replacing it would be a separate, reviewed decision. B-047’s review evidence has not been supplied, so the gap becomes REQ-015, an open request owned by the batch record owner.

The follow-up then runs as four records, each with an owner, due date and state: obtain the source, assess the gap, prepare a workflow change and verify retrieval. A request is not evidence, and a completed task does not answer the finding. The verification tests retrieval after the approved change against a defined population of later batch reviews, keeping each source, its version, the retrieval time and any exception, and the corrective action can change the workflow that produced the gap instead of adding a note to a procedure.

To compare the two in practice, ask each to package evidence for a sample in which one record has been revised since it was selected and one is missing, and see what the package shows.

4How each keeps the system validated.

Both vendors take a risk-based approach. They differ in where the evidence for a change is kept.

Ideagen offers software validation and assurance services built on FDA’s computer software assurance guidance and GAMP 5, for QMS, LIMS, ERP, MES and other GxP systems, and connects validated systems to its document control, CAPA and training.¹¹ For hosted customers of the Professional edition, Ideagen’s implementation team performs upgrades on an agreed schedule, normally outside working hours, and customers roll out a new client during an upgrade.⁴

In Seal, your team reviews Seal’s verification and release evidence for the platform version in scope, then identifies the process, configuration and integration checks its own use needs. The URS, FS, DS and configuration specification are kept in the platform, linked to the released version. When a changeset is prepared for review, its selected user acceptance tests run, and publication requires current passing results for the required tests. Earlier runs keep the version they used. An automated check supports your team’s release decision; it is not an independent declaration of compliance. The regulatory guide sets out the approach.

5Where Ideagen Quality Management is the better fit.

Ideagen Quality Management is the better fit for organisations that run quality across several standards and sectors, often beside EHS and risk, and want one vendor for all of it.

• You run quality in healthcare, pathology or accredited laboratories, working to standards such as ISO 15189 and ISO 17025, as well as or instead of GMP manufacturing.²
• You want quality, EHS, risk and compliance from one vendor on one platform.²
• Your organisation works to several standards at once, such as ISO 9001, AS9100 and IATF 16949.²
• You already run Q-Pulse and want continuity with the same product under its new name.³
• Your auditors and inspectors work in the field and need mobile forms with offline capture.⁷
• You buy through the UK government’s G-Cloud framework.⁴

6Where Seal is the better fit.

Seal is the better fit when the audit evidence and the corrective action should both live in the work, across laboratory, manufacturing and quality in biopharma.

• You want audit evidence to be the record of the work at the version selected, with later revisions flagged and gaps held as owned requests.
• You want laboratory, manufacturing and quality work on one set of records. In Seal they use a shared ontology: a sample belongs to a batch, a result comes from a test, and an investigation links to the affected work.
• You want a corrective action released as a verified change to the workflow, with its effectiveness tested on the records that follow.
• You expect to keep changing the process. Each improvement becomes a new process version with its specifications, test evidence and approvals, and earlier runs keep the version they used.
• You want an AI agent that prepares configured work. Neil assembles candidate evidence, compares selected versions with later revisions, prepares requests for what is missing and configures the request workflow from your procedure. It never releases a change on its own, and AI can be switched off for the whole organisation. 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.

7Running Seal alongside Ideagen Quality Management.

You do not need to replace Ideagen to start. Seal’s Q-Pulse connection connects selected Q-Pulse (Ideagen Quality Management) data through your approved JSON API or gateway. It reads JSON from exact GET paths beneath an approved API prefix, and the captured responses are shared with chosen Seal groups, so people can use @ references to ask Neil about findings, actions and missing evidence. The available fields depend on your installation’s API contract.

The connection is read-only. Seal does not supply a Q-Pulse gateway or perform SOAP, Windows login or session-token exchange, so SOAP, Windows authentication and private installations need an approved compatible gateway from your IT team. It does not discover modules, page through results, download linked attachments or write to Q-Pulse, and a metadata response does not give Neil a document’s text. Where operational source entity sync is enabled, Seal Scripts can map the selected data into Seal fields.

On its side, Ideagen provides an API toolkit and developer guide supporting SOAP, REST and JSON. Data is pulled from the server, only a limited set of records can be edited through the API once committed, the user’s security settings apply to API calls, and Ideagen’s technical services team can advise, although Ideagen does not build integrations for customers.⁴

8Moving from Ideagen Quality Management to Seal.

Move one process first, and keep Ideagen for the rest until you decide otherwise.

1. Choose one audit or one recurring finding, such as batch review evidence that is hard to retrieve or a gap that keeps coming back.
2. Bring the audit request, a small defined evidence population, the relevant procedures and the records you can already access. Start with sample material, or arrange an NDA before sharing confidential records.
3. Neil configures the request workflow from your procedure and prepares the candidate evidence and requests, and your quality team checks them against how the audit should run. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
4. Share the Q-Pulse responses the process needs through the connection, and prove selected versions, a missing source and a reviewed replacement before extending the workflow.
5. Agree which records move and which stay retrievable in Ideagen. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled and retrieval verified before you rely on the new workflow.

Retention obligations continue for the records that stay in Ideagen. The audit and CAPA blueprints show those workflows in detail.