Software validation · Regulated industries
Validated software.
Inspection-ready.
We validate the computerized systems, medical device software, and automation that your product quality depends on, with a risk-based approach under CSA and GAMP 5.
| URS-012 | Audit trail records user, date, and reason for change | OQ-034 | Pass |
| URS-018 | Electronic signature with two identification components | OQ-041 | Pass |
| URS-027 | Alarm on differential pressure below 10 Pa | PQ-006 | Pass |
| URS-031 | Backup and restore of electronic records | OQ-052 | In progress |
A validated system isn’t the one with the most paperwork. It’s the one that can prove, with objective evidence, that it does what it should, every time.
How we think about validation
Services
Six areas, one standard of evidence
From quality system software to plant-floor PLCs, every deliverable is built to hold up in front of an auditor.
01
CSA & CSV: Production and Quality System Software
Risk-based assurance and validation of the computerized systems used in production, laboratories, and quality management.
- Computer Software Assurance (CSA): Application of the FDA 2026 guidance, with assurance activities defined by intended use and process risk.
- Computer System Validation (CSV) under GAMP 5 (2nd Ed.): Plans, requirements, specifications, risk assessments, protocols, traceability, and reports.
- ISO 13485 / FDA QMSR: Validation of QMS software (4.1.6), production software (7.5.6), and monitoring and measurement software (7.6).
- Systems: LIMS, CDS, eQMS, MES, and ERP.
- Spreadsheets & EUC: Risk assessment, validation, and version control.
02
Medical Device Software
Lifecycle processes for software that is a medical device or part of one.
- IEC 62304: Planning, requirements, architecture, verification, configuration management, and maintenance.
- ISO 14971: Integration of software risk analysis with device risk management.
- Gap assessments and software documentation for regulatory submissions.
03
Automation & Critical Systems
Qualification of the control and monitoring systems that impact product quality.
- EMS: Qualification of systems that monitor particles, temperature, humidity, and differential pressure, including alarms and records.
- BMS / HVAC: Qualification of air handling units, interlocks, pressure cascades, and alarms.
- PLC, SCADA & DCS: Specification, testing, and qualification.
- C&Q Integration (ASTM E2500 / ISPE): Validation of automation within commissioning and qualification projects.
04
Data Integrity
Controls that ensure reliable electronic records throughout their lifecycle.
- 21 CFR Part 11 & EU Annex 11: Electronic records and signatures, audit trails, and access control.
- Data integrity assessments (ALCOA+).
- Gap assessments of systems and processes against applicable regulatory and quality requirements.
- Remediation of audit and inspection findings.
05
Lifecycle & Supplier Assurance
Maintaining the validated state after go-live.
- Periodic review.
- Change control and impact assessment.
- Data migration, obsolescence, system retirement, and data retention.
- Cloud systems: SaaS, PaaS, and IaaS.
- IT supplier qualification and audits.
06
Advisory & Training
Specialized support for internal teams.
- Validation Leads and staff augmentation.
- CSA implementation in procedures and templates.
- Training in CSA, data integrity, and Part 11.
Industries
Where software reaches the patient
For organizations inspected by the FDA, European authorities, and other regulators worldwide.
PHARMA
Pharmaceutical
GxP systems for production, quality, and laboratories.
MED DEV
Medical devices
Product and QMS software under ISO 13485 and QMSR.
BIOTECH
Biotechnology
Cleanrooms, automation, and data through scale-up.
LAB
Clinical & analytical labs
LIMS, CDS, spreadsheets, and data integrity.
How we work
From assessment to validated state
Every stage produces a controlled document. When the project closes, your team has the complete package and knows how to maintain it.
Assessment
System inventory, intended use, and gaps against applicable regulations.
Gap assessment
Strategy
Risk classification and assurance effort defined per system.
Validation plan (VP / VMP)
Specification
Traceable user requirements, specifications, and risk analysis.
URS · FS · DS · RA
Execution
Scripted and unscripted testing by risk, with objective evidence.
IQ · OQ · PQ · Traceability matrix
Release
Final report, release for use, and a plan to maintain the validated state.
Validation report
Why Validixity
Less paper, more evidence
Risk-based approach
We apply CSA to focus testing where patient and product risk is, without producing documents nobody reads.
Software and plant floor
From eQMS and LIMS to PLCs, BMS, and environmental monitoring, with one consistent method.
Audit-ready
Traceable, signed, well-organized documents your team can defend during an inspection.
Spanish and English
Deliverables and training in both languages, for local sites and global headquarters.
Knowledge transfer
Templates and procedures your staff can maintain after the project ends.
From finding to fix
Structured remediation plans for audit observations and warning letters.
Regulatory basics
Frequently asked questions
Short answers on the regulations and practices behind software validation.
What is computer system validation (CSV)?
Computer system validation is documented evidence that a computerized system does what it is intended to do, consistently and in compliance with regulations. In GxP environments it follows a lifecycle of requirements, risk assessment, specification, testing (IQ, OQ, PQ), and reporting, commonly structured under ISPE GAMP 5.
What is Computer Software Assurance (CSA), and how is it different from CSV?
Computer Software Assurance is the FDA’s risk-based approach to assuring production and quality system software. Instead of scripting every test, it scales assurance activities to the software’s intended use and its risk to patient safety and product quality, using unscripted testing where risk is low and keeping documentation to what adds value.
What does 21 CFR Part 11 require?
21 CFR Part 11 sets FDA requirements for electronic records and electronic signatures to be trustworthy and equivalent to paper. Key controls include system validation, secure computer-generated audit trails, access control, record protection and retention, and electronic signatures linked to their records. EU Annex 11 covers similar ground in Europe.
What is GAMP 5?
GAMP 5 is ISPE’s risk-based framework for compliant GxP computerized systems. It classifies software by category, scales validation effort to risk and complexity, and leverages supplier documentation. The second edition, published in 2022, aligns with Computer Software Assurance and adds guidance on agile development, cloud services, and artificial intelligence.
What does IEC 62304 cover?
IEC 62304 defines lifecycle processes for medical device software, including software that is itself a medical device. It covers development planning, requirements, architecture, verification, configuration and problem management, and maintenance, with rigor scaled by software safety class (A, B, or C) and tied to ISO 14971 risk management.
What is ALCOA+?
ALCOA+ is the set of data integrity principles regulators expect for GxP records: data must be attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available. The principles apply to paper and electronic records throughout their lifecycle.
Which systems does Validixity validate?
Quality and production software such as LIMS, CDS, eQMS, MES, and ERP; spreadsheets and end-user computing tools; medical device software; environmental monitoring (EMS), building management (BMS/HVAC), PLC, SCADA, and DCS systems; and cloud SaaS, PaaS, and IaaS platforms.
Do you work remotely or on-site?
Both. We run remote and on-site engagements in English and Spanish, from gap assessments and validation plans to protocol execution, remediation of audit findings, and training for internal teams.
Contact
Tell us which system you need to validate
We reply within one business day with an initial scope proposal.
Remote and on-site engagements · English and Spanish