Validation and computer software assurance
Validation is the documented evidence that a system, a piece of equipment or a process does what it is intended to do, consistently. QLogixCMC plans and runs validation that is scaled to risk: computer software assurance for computerized systems, qualification of equipment and utilities, and process validation across its three stages, with the evidence written so an inspector can follow it.
What we validate
- Computerized systems: QMS, LIMS, MES, ERP, CMMS, document management and laboratory instruments
- AI-enabled and agentic systems: intended use, risk assessment, test evidence and monitoring in use
- Equipment and utilities: design, installation, operational and performance qualification
- Processes: process design, process performance qualification and continued process verification
- Cleaning validation and analytical method validation support
- Data integrity controls and audit trail review procedures
How the work runs
A validation master plan sets the approach, the risk model and the deliverables for the site or the program. Each system or process then gets a risk assessment that decides how much testing it needs: a high-risk function that affects product quality or patient safety is scripted and witnessed; a low-risk one is covered by unscripted or ad hoc testing with the result recorded, as FDA's computer software assurance guidance allows.
Protocols are written from the user requirements and the risk assessment, executed with the people who will run the system, and reported with every deviation resolved. Supplier assessments and vendor documentation are used where they are adequate, so testing is not repeated for its own sake.
Validating AI-enabled systems
AI functions in a GxP system are validated by defining the intended use, assessing the risk of a wrong output, testing against acceptance criteria on a representative set of records, keeping the model and the prompts under change control and monitoring performance in use. Human review of the output is a control in the risk assessment, not a reason to skip validation.
- Intended use and the boundary of what the AI may and may not do
- Risk assessment of wrong, missing or misleading output
- Test sets with known answers, acceptance criteria and the evidence of the run
- Change control for model, prompt and configuration updates
- Periodic review against the baseline performance
Questions about validation and computer software assurance
What is computer software assurance?
Computer software assurance (CSA) is FDA's risk-based approach to establishing confidence in software used in production and the quality system. Testing effort follows the risk of the function: high-risk functions get scripted, documented testing; lower-risk functions get unscripted or ad hoc testing with the result recorded. It replaces the uniform, document-heavy approach of traditional CSV.
Do you accept vendor validation packages?
Where they are adequate, yes. QLogixCMC assesses the supplier and the package against your intended use and risk assessment, uses what covers your use, and tests only what the package does not cover or what is configured for your site.
Can AI functions be validated at all?
Yes. QLogixCMC validates AI functions by defining the intended use, assessing the risk of wrong output, testing against acceptance criteria on records with known answers, placing the model and prompts under change control and monitoring performance in use. The draft EU GMP Annex 22 sets out the same expectations.
How is validation documented for an inspection?
With a validation master plan, a risk assessment per system or process, user requirements, protocols with executed evidence, deviation records and a summary report that states whether the system is fit for its intended use. Every document is approved by your quality unit before the system is released.
Related services
- CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.
- Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.
- Investigations, CAPA and backlog remediationDeviation, OOS and complaint investigations that reach a defensible root cause, CAPAs that are checked for effectiveness, and aged backlogs cleared without lowering the standard.
- Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.
- GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.
- AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.