What a QMS costs a small pharma company
Four costs, with published figures. The license is the one vendors quote and the smallest of the four.
A quality management system has four costs. Vendors quote the first one.
- Licenses
- Implementation
- Validation
- Staff time to run it
This page gives published figures for all four. Hemeralis QMS comes out of twelve years of implementing quality systems for pharmaceutical and biotechnology companies.
1. Licenses
Enterprise systems start at about $200 per user per month. Mid-market systems cost about $2,000 per user per year. For twenty people that is $40,000 to $48,000 a year.
Two things to check in a quote:
- Most vendors charge per named user, not per concurrent user. A supervisor who signs four deviations a year then costs the same as a QA manager.
- Document control, training and supplier management are often priced separately.
2. Implementation
This covers configuration, data migration, integration and training.
Published figures put year-one implementation and validation together at $50,000 to $150,000, excluding the subscription. The cost depends on how much you change. A system left close to its defaults is cheaper to set up.
3. Validation
Validation requires specific documents:
- a User Requirements Specification, stating what the system must do;
- IQ, OQ and PQ protocols, testing the system against those requirements;
- a traceability matrix, linking each requirement to the test that verifies it.
The protocols are then executed and signed, and an independent reviewer approves the result.
Published figures: 150 to 400 hours of internal QA time at $80 to $120 per hour. An external validation consultant costs $175 to $250 per hour, for 100 to 250 hours. Keeping the system validated afterwards costs $20,000 to $75,000 per year, because every vendor upgrade must be assessed.
What validation involves, in detail, and who is responsible for it.
Two points are often missed:
- Executing a workflow protocol needs at least two people who can sign. The system separates the person who performs an action from the person who approves it.
- Validation is a recurring cost, not a one-time cost.
4. Staff time
Someone must administer the system: users, roles, workflow changes and the periodic access review. In a company of twenty this is part of the QA manager's job. It does not appear in any quote.
Year one, for twenty people
| Item | Range |
|---|---|
| Licenses, 20 users | $40,000 – $48,000 |
| Implementation and validation | $50,000 – $150,000 |
| Year one | $90,000 – $198,000 |
| Each year after | $60,000 – $123,000 |
These are published market figures, not a quote. Your figure will differ. The proportion will not: the license is about a quarter of the first year.
Why the enterprise systems cost this
They are built for companies with several manufacturing sites, a validation department and a full-time system owner. Every capability has to be configured, validated and maintained.
If you have those departments, the price is reasonable. If you have twenty staff, you are paying for a structure you do not have.
Questions to ask a vendor
- Is the price per named user or per concurrent user?
- Which modules are included in that price?
- Which validation documents do you supply, and which must the customer write?
- At your next upgrade, who re-tests the system and who pays?
- How many people do your customers of this size assign to administer it?
- What does it cost to leave, and in what format do you return the records, the files and the audit trail?
What Hemeralis does differently
Hemeralis QMS is built for companies with no validation department and no IT department.
Light User seats
Hemeralis has four license tiers. A Light User can be assigned records, sign transitions and approve in parallel. A Light User cannot create records, and costs less than a full seat. Occasional approvers go on this tier.
The validation package is supplied
Hemeralis provides the requirement specifications, the IQ, OQ and PQ protocols, and the traceability matrix. Writing these documents is most of the validation cost. You execute them instead of writing them.
Hosted in the European Union
The application, the database and all stored files run in Frankfurt. GÜNES CONSULTING OÜ is an Estonian company. Data does not leave the EU.
The same controls as the enterprise systems
- electronic signatures with two authentication factors;
- a tamper-evident audit trail;
- segregation of duties enforced by the workflow;
- fields locked by workflow status;
- a compliance export written for an inspector.
What Hemeralis does not do
Hemeralis does not make validation free. If you run a regulated process on our software, you validate it, as you would with any vendor. We supply the documents. You execute them, and you still need two people who can sign.