IndustriesBiotechnology
Biotech QMS software that grows from trial to manufacture
QMSdesk™ is biotech QMS software that fits the stage you're at and takes on the next regulation when you get there. Run your trials under GCP today. Add GMP and ATMP when you start to manufacture, in the same system, with every record you already have.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; ICH E6; 21 CFR Part 312; ICH Q10; 21 CFR Parts 210/211; EU GMP (EudraLex Vol. 4), including Annex 11; ICH Q7; WHO GMP (Technical Report Series); EudraLex Vol. 4 Part IV
- Retention floor
- 30 years
- Event workflows
- 12, including Product recall and ATMP process nonconformance
- Key deadline
- Batch deviation containment within 1 calendar day
A typical starting set. You choose your own profiles, and can add more at any time.
What a biotech needs from an eQMS
A quality system that's right-sized for a small team now and never has to be rebuilt as the science moves forward.
The year of your first GMP batch. You've logged protocol deviations in QMSdesk for two years. Now you add the GMP profile. Batch deviations and the QP role arrive beside everything you already run, and every existing record keeps the rules it was created under.
What the rules ask of you, and how QMSdesk supports it
A biotech's rules change as the science moves: clinical trial rules first, manufacturing rules when you make your first GMP batch, and advanced-therapy rules if you make cell or gene therapies. QMSdesk adds each set of rules to the same system when you need it, and every record you already have keeps the rules it was created under.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| GCP (ICH E6 and 21 CFR Part 312) | How clinical trials are run and recorded. | Protocol deviations, the Principal Investigator, CRA and Medical Monitor roles, and 15-year minimum retention. |
| GMP (21 CFR Parts 210 and 211, EU GMP, ICH Q7, WHO GMP) | How medicines are made, tested and released. | Batch deviations contained within 1 calendar day, and the Qualified Person role. |
| ATMP (EudraLex Vol. 4 Part IV) | Extra GMP rules for advanced therapies. | Every process nonconformance tied to its cell line, batch and critical quality attribute. Every record kept for at least 30 years. |
| ICH Q10 | A pharmaceutical quality system that keeps improving. | CAPA and change management run as connected systems, in GCP and GMP alike. |
| 21 CFR Part 11 and EU GMP Annex 11 | Electronic records and signatures you can trust as much as paper. | A hash-chained audit trail the database keeps insert-only, and re-authentication at every signature. |
| Computer Software Assurance | A risk-based way to show the software is fit for use. | A validated core platform, and a written scope for the validation that stays yours. |
Every customer also holds BASE, the quality baseline, which carries 21 CFR Part 11, ALCOA+, ISO 9001 and ISO 31000. Running nonclinical safety studies too? Add the GLP profile.
The profiles that carry your regulations
Running trials and manufacturing, you hold BASE, GCP, GMP and ATMP. Where two profiles differ, the stricter rule applies.
Event types
Protocol deviation on the deviation workflow. Batch deviation, environmental excursion and product recall from GMP. ATMP process nonconformance, covering cell line, batch and critical quality attribute.
Deadlines
Batch-deviation containment within 1 calendar day. OOS Phase 1 laboratory investigation within 1 business day.
Roles
Principal Investigator, CRA, Medical Monitor and Biosafety Officer from GCP. Qualified Person, QC Head, Production Head, Responsible Person, Validation Engineer and Batch Release Specialist from GMP.
Retention floor in QMSdesk
30 years. Retention follows the longest minimum you hold, so ATMP sets it for your records.
Making biologics without advanced therapies? You hold BASE and GMP, with 10-year minimum retention.
QMS for clinical-stage biotech
Not manufacturing yet? Start with BASE and GCP, with protocol deviations, the clinical roles and 15-year minimum retention. Add GMP and ATMP later, including after go-live, under e-signature and change control. A profile, once added, stays.
Everyone can work in QMSdesk. It's priced by organization tier, never per seat, and every tier includes every module. Grow past your tier, and nobody is locked out.
Biotech QMS software modules that matter most
Quality events and deviation management
Protocol deviations, batch deviations and ATMP process nonconformances each run on a signed workflow. Anyone can report an event, and control applies from triage onward.
CAPA
A CAPA can start from a deviation, an audit, a trend or a management review. An effectiveness check confirms each fix held, and a failed check raises a new linked CAPA.
Document control
Protocols and SOPs are signed at authoring, review and approval, by different people. Training is assigned when a document is approved.
Training management
Acknowledgment, quiz, practical assessment or external certificate. Overdue training for a GxP-critical (critical to quality) role opens a risk.
Supplier quality
Qualify the partners you depend on by risk tier, with reviews every 6, 12 or 24 months. Suppliers answer corrective-action requests through a single-use link, with no account.
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality, management review and reporting. See the whole platform
Build your regulatory profile
Compare running trials alone with trials and manufacture, and see how your event types, roles and minimum retention period change.
Questions buyers ask
We're clinical-stage. Do we need GMP now?
No. Start with GCP and add GMP and ATMP when you're ready. Adding a profile brings its obligations to new records, and existing records keep the rules they were created under.
Why does ATMP set a 30-year minimum retention period?
EU GMP for advanced therapies requires long-term traceability. QMSdesk keeps one retention clock per organization, set to the longest minimum retention period among your profiles, so holding ATMP sets it at 30 years.
Can we run GCP and GMP in one QMS?
Yes. Hold GCP and GMP together, with ATMP if you make advanced therapies. Protocol deviations and batch deviations sit side by side, and the strictest deadline applies.
How is QMSdesk priced for a small team?
By organization tier: Early-Stage & Startup covers 1–25 users, and every tier includes every module. Early-stage teams can apply for the 2026 Early Adopter Program.
Built for the company you're becoming
Bring the workflow that worries you most. We'll show you QMSdesk running it today, and after your first batch.
Early-stage or growing fast? Join the 2026 Early Adopter Program for early-stage and growth teams.