Modules

Every quality process, in one system

You license the modules you need. Each one has its own form, its own workflow and its own approvals, and the records link to one another.

Complaints

What a customer, a patient or a distributor tells you about a product, from the first contact through to the decision about what it was.

Complaint Intake

The first record: who got in touch, how, about which product, and what they said. It is triaged, and Quality then decides whether it is a complaint at all or whether it becomes one.

Complaint

What an intake becomes once Quality escalates it — handled under the same audit trail, electronic signatures and workflow control as every other record.

Deviations & Investigations

From the moment something goes wrong to the moment quality signs it closed.

Deviation

Intake, QA review, root cause and CAPA, final approval. An 18-category taxonomy, a 6M root-cause analysis and a regulatory-reporting assessment.

Investigation

Raised from a deviation that needs one. Eleven investigation methods, concluded and approved separately from its parent.

CAPA & Effectiveness

The corrective action, and the proof afterwards that it actually worked.

CAPA

Root-cause analysis, planned actions, implementation, verification and closure. Raised from a finding, from a deviation, or on its own.

Effectiveness Check

Raised from a CAPA and planned, executed and closed on its own. The CAPA cannot close until the check says the actions worked.

Change Control

A planned change, assessed by the functions it affects, carried out as tracked actions.

Change Control

Plan, assessment, approval, implementation, final approval and closure. The plan can name any number of approvers, who sign in parallel.

Change Assessment

One assessment per affected function or department, raised from the parent change and answered by the people who own that area.

Change Action

The work the change requires. An action cannot be assigned before the change plan has been approved, and the change cannot close until every action has.

Change Effectiveness

The check that the change did what it was meant to do. A plan is written and approved, the check is carried out against stated criteria, and Quality closes it as effective or not.

Audits

The annual program, the audits inside it, and the findings they raise.

Audit Plan

The annual program. Audits are added while the plan is in draft, and the plan cannot close until its audits do.

Internal Audit

Plan review, preparation, execution, responses, verification, closure — with the auditor and the auditee as separate actors throughout.

External Audit

Regulatory inspections, customer audits and certification audits, with their own preparation checklist and response cycle.

Audit Finding

Severity-graded, issued to a named responder, answered by them and verified by the auditor. A finding can lead straight into a CAPA.

Document Management

Controlled documents — procedures, work instructions, specifications and forms — written, reviewed, approved and kept in force under the same controls as every other record.

Document

Each version is its own record, numbered in your own format and routed through as many review and approval rounds as your process needs. A document stays in force while it is being reviewed, and the version that replaces it supersedes it the moment it takes effect.

Document types and routing

You set up your own document types — numbering, retention, review period, versioning — and the review and approval routes they follow. A route is fixed to a document the moment it is raised, so changing the route later never alters a document already in progress.

Read in the browser

A document opens on screen. No download, no plugin, no viewer to install. Word, Excel, PowerPoint, OpenDocument, PDF, plain text, CSV, XML and the common image formats are all rendered for reading, so nobody keeps an uncontrolled copy on a laptop to read a procedure.

Controlled printing

A paper copy is issued with its own number and entered in a register: which version, who holds it, and when it was issued. When a new version takes effect, every copy still outstanding is marked superseded, so you can see at any moment what paper is on the floor.

Across every module

Supporting records

Available with every module you license.

Due Date Extension

The only route by which a locked due date may move: requested, justified, approved and signed. Nobody edits a due date directly.

Products

Finished products and APIs, with product family, therapeutic area and disposition — referenced from quality records so a deviation or a change names a real product.

Materials

Raw materials, excipients and packaging, with the manufacturer, the supplier, the part number, the unit of measure and the specification they are accepted against.

Devices

Medical devices, with the identifiers a device file needs: UDI-DI, GMDN code, regulatory classification and intended use, and whether the device is serialized or lot controlled.

Administration

Users and licenses, functional roles, controlled vocabularies, company profile, record reassignment, and a readable view of every business process you run.

Records lead to one another

A finding leads to a CAPA. A CAPA leads to an effectiveness check. Nothing is retyped, and every link is visible from either end.

The deviation process

Deviation Investigation CAPA Effectiveness Check

A dashed step is raised only when the review says it is needed.

The audit process

Audit Plan Audit Audit Finding CAPA

The change process

Change Control Change Assessment Change Action Change Effectiveness

The complaint process

Complaint Intake Complaint Investigation CAPA Effectiveness Check

Which linked records are allowed is decided by the workflow and by the answers recorded on the record itself. Say an investigation is not needed and Hemeralis asks you to justify that in writing, and never offers the button to create one.

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