Validation experts
GxP-trained specialists across QA, IT and operations.
Microsoft Partner
Data-driven, AI-enhanced validation
for regulated operations.
Audit-ready validation, governed end-to-end.
21 CFR Part 11EU Annex 11GAMP 5ISO 27001
Full lifecycle coverage
From URS to release, governed end-to-end.
Audit-ready by design
Traceable evidence, signed and exportable.
VAL-LIFECYCLE / LIVE
ACTIVE
- 01URSRequirements
- 02FSSpecification
- 03TSTest design
- 04EXECExecution
- 05RELRelease
Stage
URS
Progress
0%
Status
IN PROGRESS
Software Customers
From primary industry to government agencies.
Regulated organizations across pharma, biotech, medical devices, hospitals, and public health run validation on our platform.
The problem
Validation today is fragmented.
Across regulated organizations, validation lives in disconnected tools and inconsistent processes. The result: slow approvals, weak traceability, data integrity risk, and constant audit pressure.
Disconnected approvals
Reviews scatter across email, shared drives, and paper signatures.
Spreadsheet chaos
Traceability lives in fragile workbooks. No data integrity anyone fully trusts.
Inconsistent workflows
Each site executes validation differently, with no shared baseline.
Limited lifecycle visibility
Status, dependencies, and bottlenecks stay hidden until audit.
Audit stress
Inspection prep means rebuilding evidence from disconnected sources, with no assurance every validation document and ALCOA+ data-integrity practice is in place.
Slow time to value
Manual handoffs and rework stretch validation cycles, delaying release and tying up expert capacity.
The platform
One connected system for validation operations.
VLMcare unifies validation lifecycle management, workflow orchestration, fail-safe data integrity, and audit readiness in a single platform built for GxP-regulated environments.
01
Lifecycle control
Maintain visibility across every validation stage, dependency, and approval.
- State transitions
- Cross-site governance
- Periodic review
02
Data-driven execution
Validation lives as connected data, not folders of files. Requirements, test cases, approvals, and traceability stay linked and current.
- Connected records
- Live traceability paths
- Linked change control
03
Audit readiness
Always inspection-ready, with complete traceability and tamper-proof audit logs for data integrity.
- Immutable audit trail
- Part 11 e-signatures
- Auto-generated RTM
04
AI-enhanced validation
Coming nextAI assists authoring of URS and test cases, surfaces coverage gaps, drafts impact assessments, and assembles inspection-grade evidence packs.
- AI-assisted authoring
- Coverage intelligence
- Audit-grade evidence assembly
Data, not documents
Why teams choose VLMcare over document-based eVLM tools.
Most eVLM tools manage documents. VLMcare manages validation as data. Requirements, test cases, approvals, traceability, and audit packs live as connected records. AI works on top of structured data, not files, which is why our roadmap moves faster.
Capability
Document-based eVLM
VLMcare
Source of truth
Documents
Connected data
Traceability
Manually maintained
Auto-generated and live
Coverage detection
Reviewer effort
AI-assisted
Audit pack assembly
Compile from folders
One-click from records
AI extensibility
Limited
Native, structured
Time to value
Up and running in 2 to 3 months, not 6 to 8.
VLMcare deploys on a standard configuration designed for GxP-regulated environments. You start validating real systems in the first quarter, not the third. Faster deployment means faster ROI, improved efficiency and product throughput, less defect burden on your shop floor, and less change drag on the QA team.
Approach
Typical deployment time
VLMcare
2 to 3 months
Document-based eVLM tools
6 to 8 months
Workflow orchestration
From documents to connected lifecycle.
VLMcare models validation as connected states, approvals, and dependencies — not folders of files. Every transition is governed, traceable, data-integrity-validated, and inspection-ready.
State transitions
Every status change is governed by configurable rules and workflows.
Linked dependencies
Change controls, deviations, and CAPAs connect to validation records.
Traceability paths
Requirements link to test cases automatically. Coverage stays current and visible.
Technology stack
Built on the Microsoft stack.
Unlike solutions built on unsupported or niche technologies, VLMcare is powered by Microsoft's enterprise platform. As a Microsoft Partner we provide native SQL Server, .NET, and Azure integration, reducing implementation risk, accelerating user adoption, and leveraging the infrastructure and expertise your IT team already has in place.
Microsoft Partner
SQL Server
.NET
Azure
Governance and trust
Built for inspection readiness and validation compliance.
VLMcare aligns with the standards your governing body auditors already expect. Compliance and regulatory support for GxP is structural, not bolted on.
"We replaced six tools and a binder of SOPs with one validation system. Audit prep moved from weeks to hours."
21 CFR Part 11
Electronic records and signatures.
EU Annex 11
Computerised systems compliance.
GAMP 5
Risk-based validation methodology.
ISO 27001
Information security management.
SSO + RBAC
Enterprise identity and role control.
Tamper-evident audit trail
Every action signed and timestamped, supporting ALCOA+.
Data Readout / Outcomes
Operational results, not just features.
VLMcare customers report measurable improvements in how validation and data integrity are done, with more focus on patient safety and less on correcting errors and mistakes.
VLMcare / Outcome MetricsLive
M-01
60%
Reduction in review cycles
M-02
3×
Faster audit preparation
M-03
100%
Traceability coverage
M-04
0
Paper in the validation process
- Improve throughput by reducing bottlenecks across teams and sites.
- Enhance lifecycle visibility for validation leads and quality heads with real-time updates.
- Accelerate validation execution without sacrificing rigor and product quality.
- Standardize validation operations across regulated business units.
- Eliminate fragmented validation workflows, disconnected data integrity, and human errors.
- From Idea to Patient: fast, compliant, and confidently built with CARE.
Part of QbD Group
VLMcare is part of QbD Group
From Idea to Patient: fast, compliant, and confidently built with CARE
VLMcare is proud to be part of the QbD Group, your strategic partner in Life Sciences. Together we accelerate validation, secure compliance, and bring innovation to patients with confidence.
QbD Group is a global life science partner that accelerates product development from idea to patient. With integrated expertise in regulatory, clinical, quality, and operational domains, we help companies bring their innovations to market faster and with confidence.
20+
Years of expertise
700+
Full-time professionals
500+
Enterprise customers
10+
Countries
Global presence
Headquartered in Belgium, with offices across Europe and the United States. Financially strong and stable, serving life science organizations worldwide.Expert team
Over 700 full-time professionals, including a dedicated team of software developers serving 500+ enterprise customers across life sciences.Learn more about QbD GroupRequest a demo
See VLMcare in your validation environment.
A working session with our team. We map your current validation flow against the platform and show where it tightens governance.
- 30-minute working session, mapped to your current validation flow. You walk away with three concrete improvement opportunities.
- Mapped to your current validation flow
- Compliance and audit readiness review
Trusted by quality teams across regulated industries, building on more than a decade of Rescop eVLM deployments.
"Audit prep moved from weeks to hours."
Director, Quality Systems · Top 20 pharma
60%
Fewer review cycles
100%
Audit traceability
24/7
Inspection-ready