The proactive, risk-based eQMS for life sciences
Your quality system, always one step ahead.
Built from the regulations up. Enforced as code. Closed-loop by design. Every issue finds its owner early, and every fix can be proven.
Command Center
Executive oversight
Quality Health Index
Across every module
Audit readiness
On track
Next audit in 3 days
Risk posture
Needs your attention
By module
CAPA open
Training compliance
Document in review
Qualified suppliers
Risk opened automatically
Supplier certificate expired
Owner assigned from the supplier record
CAPA-001 raised
From the signed CAPA decision on DEV-001
Change control and training follow on plan approval
- 10 modules
- in every tier, never sold as add-ons
- 12 profiles
- configure the system from your regulations
- SHA-256
- hash-chained audit trail, verified daily
- 25 years
- of GxP quality practice behind the build
Proactive, risk-based quality
A week with QMSdesk
In QMSdesk, proactive quality isn't a dashboard you remember to check. The work starts itself the moment something changes, and it lands with the right person.
Monday morning
A supplier's certificate expired over the weekend. The risk is already open in the register.
Tuesday
An operator on the second shift logs a deviation. Everyone is in the system, so it's recorded the moment it happens.
Wednesday
The investigation reaches its CAPA decision, and the signed decision raises the CAPA. When the action plan is approved, the change control and training it needs are raised with it.
Thursday
A risk is re-assessed as critical. QMSdesk raises its CAPA automatically, and only once.
Friday
Management review works from a frozen snapshot of your quality system, so the minutes and the evidence always agree.
That's proactive, risk-based quality: risk opens the right work, and your team spends its time closing it.
Rule-based and traceable. QMSdesk puts no AI model in any regulated decision path.
See how the risk engine worksClosed-loop by design
From first signal to proven fix, on one record.
Follow one deviation through QMSdesk. Every step is a typed, attributed link, so anyone can trace the chain from the signal to the proof.
- DEV-001Critical
Temperature excursion during storage, batch BT-4201
- 1Reported
- 2Containment
- 3Investigation
- 4CAPA decision
- 5QA approval
- 6Closed
01
The deviation is recorded
An operator logs a temperature excursion the moment it happens. A critical severity routes it through containment first.
- Risk assessmentRequiredSeverity5Probability2Detectability2
Risk level High, set by severity dominance
02
Risk is assessed
Critical severity makes a risk assessment required, made by a person. A maximum-severity hazard never scores below High.
- CAPA-001Implementation
- SourceDEV-001, signed CAPA decision
- ChangeCC-003, storage monitoring SOP-022
- TrainingAssigned to affected roles
03
The fix is committed
The signed CAPA decision raises CAPA-001 in the same transaction. Its approved plan raises the change control and training it needs.
- Effectiveness checkScheduled
After closure, over the interval you set
The signed record stays exactly as it was
04
The fix is proven
After closure, an effectiveness check follows, over the interval you set. If it doesn't hold, a new linked CAPA is raised.
The platform
Every quality process. One connected system.
Ten modules and the platform services that hold them together, included in every tier.
Document control
The current version, always, with the right signatures behind it.
Quality events
Deviations, complaints and OOS results, each on its own path.
CAPA
Commitments that get done, and proven.
Change control
Change with the right eyes on it.
Training and competency
Everyone trained on what changed.
Risk management
The layer that connects everything.
Audit management
Audits that run to plan, with findings that go somewhere.
Supplier quality
Suppliers qualified by risk, answering without an account.
Management review
Minutes and evidence that always agree.
Reporting and analytics
The state of your quality system, any day.
Platform services
Audit trail and e-signaturesRegulatory profilesWorkflow engine, implementation and go-liveAccess and governanceRecords and retentionSAML single sign-on and a REST APIBuilt from the regulations up
Tell us what you do. See the rules your QMSdesk will run on.
Twelve regulatory profiles set the event types you record, the roles that sign, the deadlines you keep, how long you retain records and how you score risk. Hold more than one, and the strictest rule wins.
What does your organization do?
Profiles you'd hold
BASE (quality baseline), GMP
Workflows you record
Incident, Deviation, Nonconformance, Complaint, OOS / OOT investigation, CAPA, Supplier issue (SCAR), Batch deviation, Environmental excursion, Product recall
Enforced as code
Your SOPs, followed every time.
Every workflow in QMSdesk is a versioned definition. Its steps, signatures, required fields and deadlines are built in, and a daily check keeps each one current.
The right person signs, in the right order. An author never sees the option to approve their own document. The Administrator configures the system but holds no quality approvals, and emergency or vendor-support access can never sign. After go-live, a setting that affects your validated state changes only through approved change control.
- Locked steps and transitions
- Segregation of duties at every signature
- Change control on validation-affecting settings
Document approval, version 4
Controlled documents
Steps
An author never sees the option to approve their own document.
Data integrity
Every record, provably intact.
Every audit-trail entry is SHA-256 hash-chained to the one before it, and the database keeps the log insert-only. Each day, QMSdesk re-verifies every chain and checks that every signature still points to its record.
Open the Command Center to see your quality system as it is today, across Executive Pulse, Inspection Readiness, Risk Command, Training Intelligence and Notification Activity. Every figure opens the records behind it. When an inspector arrives, give them a time-boxed, read-only account: they can see and export what they need, and change nothing.
Visit the Trust Center9f3a…c21e4b7d…08fae21c…9b4071aa…d3e5Pricing
Everyone in. No one locked out.
Priced by organization tier, never per seat. Every tier includes every module, and growing past your tier never locks anyone out.
Early-Stage & Startup
1–25users
Every module included
Growth & Mid-Market
26–250users
Every module included
Enterprise & Multi-Site
251+users
Every module included
Approx. 60%
lower 5-year TCO vs. legacy per-seat suites
Positioning estimate, not a measured result
Validation and people
Start from a validated core platform.
QMSdesk's core platform is validated under a QA-approved Validation Summary Report, and we'll walk you through the full record under a mutual NDA. Every engagement comes with a written validation scope, so you know exactly what's done and what remains yours.
Excellence isn't an event you prepare for. It's a habit your system makes easy: every step clear, every record connected, every risk seen early enough to act on.
Abdul AzamFounder & CEO, Akatalyst Technologies. 25 years in regulated life-sciences quality.Built for your part of life sciences
Find your starting point
Questions buyers ask
What is QMSdesk?
QMSdesk is a cloud eQMS for life sciences. It connects document control, quality events, CAPA, change control, training, risk, audits, supplier quality and management review in one system, configured from the regulations you work under. QMSdesk is an Akatalyst platform.
What makes QMSdesk proactive?
Risk drives what happens next. Risks open on their own when a supplier certificate expires, a document review runs more than 30 days late, or training for a GxP-critical role lapses. A critical risk raises its CAPA. Scrutiny scales with risk, from approvals to effectiveness checks. It's all rule-based and traceable, and no AI model sits in any regulated decision path.
Does QMSdesk support 21 CFR Part 11 and EU GMP Annex 11?
QMSdesk is designed to support electronic-record and electronic-signature controls relevant to regulated use. That covers a hash-chained audit trail, audit-log immutability enforced by the database, re-authentication at every signature with multi-factor where you require it, recorded signature meaning, and segregation of duties. The certification under Part 11 §11.100(c), that your electronic signatures are the legally binding equivalent of handwritten ones, is yours to file with the FDA.
Who validates QMSdesk?
QMSdesk's core platform is validated under a QA-approved Validation Summary Report, and your system is validated by you. We'll walk you through the full record under a mutual NDA. Every engagement includes a written validation scope, and Akatalyst's practitioners can carry out your share of the work.
How long does implementation take?
The target for a first working workflow is 8–12 weeks, depending on scope, data readiness and your team's availability. You configure and test in your real tenant through the Configuration Runway, and go-live takes two separately signed readiness attestations.
How is QMSdesk priced?
By organization tier (1–25, 26–250 or 251+ users), never per seat. Every tier includes every module, and growing past your tier never locks anyone out. Early-stage and growth teams can apply for the 2026 Early Adopter Program, at a rate 60% below the standard subscription.
Can we bring our existing documents?
Yes. Legacy documents come in under a signed migration attestation for each batch and carry a permanent "Migrated" badge. QMSdesk never presents a migrated document as one approved inside the system.
How is our data protected?
Each organization's data is isolated by row-level security in the database. The audit trail is hash-chained and insert-only, and QMSdesk is hosted with a cloud infrastructure provider that holds a SOC 2 Type II attestation; that attestation is the provider's, not ours. The Trust Center has the detail.
Bring one workflow. We'll show you QMSdesk running it.
A CAPA backlog, an audit finding, a document bottleneck: bring a real one, and we'll walk it through QMSdesk with you.
2026 Early Adopter Program. An early adopter rate 60% below the standard subscription, for a limited cohort of 15 organizations. Apply