Compare the editions
Your company chooses one of two editions. Each person then gets a license type, by what they do. Both editions include every module.
| CoreReady to use, self-serviceFor companies moving from paper to eQMS | TailoredBuilt around your processesFor companies that change their workflows and processes | |
|---|---|---|
| Users | Up to 15 · Read Only users not counted | No limit |
| Environments | Production, Sandbox | Development, Validation, Production |
| Configuration | Standard, out of the box | Workflow and process changes, as a consulting service quoted separately |
| Support | Product defects and feature requests, through the customer portal | Standard Support: onboarding, how-to questions, bug reports, feature requests |
| Storage | 50 GB | 150 GB |
| Extra storage, per block | 20 GB | 40 GB |
| Modules | ||
| Deviations | Included | Included |
| CAPA | Included | Included |
| Change Control | Included | Included |
| Audits | Included | Included |
| Complaints | Included | Included |
| Document Management | Included | Included |
| Master Data | Included | Included |
| In every edition | ||
| Electronic signatures and audit trail (21 CFR Part 11, EU GMP Annex 11) | Included | Included |
| Interface in five languages | Included | Included |
| Product updates and fixes | Included | Included |
| Backup of your data | Included | Included |
License types
Every license type works in every module. Choose a type for each person, by what they do.
System Administrator
The person who runs Hemeralis for your company.
- Everything a Full Edit user can do, plus
- Users
- Invite users and set their license type and language
- Assign functional roles
- Deactivate and reactivate users, reset passwords, change email addresses
- Configuration
- Manage picklist values, such as sites and departments, in five languages
- Maintain master data: products, materials, devices, harms and hazardous situations
- Set company time zone, language, currency and date format
- Administer Document Management: document types and routing templates
- View every business process and its workflow
- Security and records
- Set session timeouts, an IP allow list and multi-factor authentication
- See the sign-in history of every user
- Record Reassignment: move open records to another person when someone leaves
- Release a record locked by another user
- Compliance Export: a complete record with its signatures and audit trail
- Verify that a record’s audit trail is intact
- Read every module, every document version included
Full Edit
Members of your quality team.
- Create records, with the matching functional role, for example Deviation Owner
- Edit the records they are involved in
- Move records through their workflow
- Sign electronically
- Approve, when named as QA Approver
- Raise child records: investigations, CAPAs, effectiveness checks
- Request due date extensions
- Attach files
- Print records and export them with their audit trail
- Read every quality module; Document Management with its functional role
- Administer users and settings
Light User
People who take part without raising records, such as approvers or the person a CAPA is assigned to.
- Be assigned records
- Edit the records assigned to them
- Move records through their workflow
- Sign electronically
- Approve, when named as QA Approver or in a list of approvers
- Attach files
- Print records and export them with their audit trail
- Read every quality module; Document Management with its functional role
- Create records
Read Only
People who need to read, such as SOP readers and managers.
- Read the modules their functional roles open
- Read effective SOPs and other documents in force
- See the audit trail of what they can read
- Print and export what they can read
- Complete assigned training and sign it (when Training Management is released)
- Edit records, or sign records other than training
Optional add-ons
Premium Support
More support than your edition includes. Ask us for the details.
Your own Hemeralis subdomain and sign-in page
Your users sign in at yourcompany.hemeralis.com, on a page with your logo and your colors. For your Production environment.
A copy of your data in a second European data center
Your data is also kept in another European data center.
A yearly subscription for the edition, plus a license for each user. Choose a one-year or a three-year subscription. The three-year subscription has lower prices in years 2 and 3. Prices are exclusive of VAT and quoted for each company.
Request a quotationGood to know
Core is self-service.
Your team learns from the user and administrator manuals and the training videos. You can raise a ticket when the product does not work as described, or to request a new feature.
No implementation fee for Core.
We set up your Production and Sandbox environments and your first System Administrator account. The standard quality workflows are ready to use.
Data migration is not available yet.
Moving your existing SOPs, records and other data into Hemeralis is not offered today.
Backup is included.
Every edition includes a backup of your data. A copy of your data in a second European data center costs extra. It is available for Tailored.
Your records are kept.
Hemeralis never deletes a file. Removed files and earlier document versions are kept and count toward your storage. In Production, files are locked against deletion for 10 years.
Stored in the European Union.
Your data is hosted in Frankfurt, Germany.
No module is sold separately.
Every edition includes every module, Document Management included.