Regulated Systems
Validated, compliant, and audit‑ready software for life sciences, medical devices, and GxP environments.
Ensure ComplianceValidated Systems
Computer System Validation (CSV), GxP compliance, and FDA Part 11 ready platforms.
Computer System Validation (CSV)
IQ/OQ/PQ protocols, risk‑based validation, and documentation packages for regulatory submission.
21 CFR Part 11 Compliance
Electronic signatures, audit trails, and data integrity controls for FDA‑regulated systems.
GxP Environment Management
GMP, GLP, GCP – validated infrastructure, change control, and periodic review.
LIMS & Laboratory Systems
Validated lab information management systems with chain‑of‑custody and electronic records.
Change Control & Deviation Management
Track system changes, deviations, and CAPA within regulated quality management systems.
Data Integrity (ALCOA+)
Design systems that ensure attributable, legible, contemporaneous, original, and accurate records.
Regulatory Frameworks
We build and validate systems to meet global regulatory standards.
FDA 21 CFR Part 11
Electronic Records / Signatures
EU Annex 11
Computerised Systems (EU GMP)
GAMP 5
Risk‑Based Validation Approach
ISO 13485
Medical Device Quality Management
ISO 9001
Quality Management Systems
ICH Q7 / Q9 / Q10
GMP for Active Ingredients / Risk / Quality
Our Validation Lifecycle
A documented, risk‑based approach aligned with GAMP 5.
User Requirements
URS definition and functional specs
Risk Assessment
Identify critical functions and impact
IQ / OQ / PQ
Installation, operational, performance qualification
Trace Matrix
Link requirements to test cases
Periodic Review
Ongoing compliance and change control
Industries We Serve
Where validated systems are mission‑critical.
Pharmaceutical Manufacturing
Validated MES, ERP, and warehouse systems for batch release and serialization.
Medical Device Development
Design Controls, DHF, and software validation for Class II/III devices.
Biotech & Cell Therapy
Chain‑of‑identity systems, cryo tracking, and GMP lab informatics.
Clinical Research (CROs)
21 CFR Part 11 compliant EDC, CTMS, and eTMF platforms.
Technologies We Validate
Platforms and tools that can be deployed in validated environments.
Need a Validated System?
Let's build a compliant, audit‑ready software platform for your regulated environment.
Talk to a Validation Expert