CSV/CSA governance
Risk-based validation strategy, CSA principles, GAMP 5 aligned documentation and regulated system lifecycle support.
- Intended use and GxP impact
- Risk model and assurance strategy
- Validation template and SOP review
About Sparko Quality Consulting
Founder-led CSV/CSA, validation, QMS and QA/RA support.
Sparko Quality Consulting is led by Yazan Alnababtah, a CSV/CSA, QA/RA and validation professional supporting regulated MedTech, pharmaceutical, biotech, diagnostic and healthcare environments.
Real specialist expertise, not generic compliance copy.
Sparko is positioned around the areas where Yazan brings the strongest commercial value: CSV/CSA governance, GAMP 5 aligned validation, GxP systems, QMS remediation, audit readiness and QA/RA documentation support.
Yazan Alnababtah is the Director of Sparko Quality Consulting and a CSV/CSA, QA/RA and validation professional with 9+ years of experience across medical device, pharmaceutical, biotechnology, diagnostic and healthcare environments.
His work includes risk-based validation strategy, GAMP 5 aligned computer system validation, QMS implementation and remediation, ISO 13485/ISO 9001 support, audit readiness, CAPA, supplier quality, technical documentation and regulated system lifecycle documentation.
Sparko supports QA, RA, IT, validation and system-owner teams that need practical, proportionate and defendable compliance evidence without unnecessary documentation burden.
Core expertise
Support combines technical validation knowledge, QA/RA understanding and practical quality-system delivery.
Validation lifecycle delivery
Practical support for requirements, risk assessment, protocols, traceability, execution support and closeout evidence.
- URS, RTM, IQ/OQ/PQ
- FAT/SAT and execution support
- Validation summary reports
QMS implementation and remediation
Support for controlled documentation, usable records, CAPA, supplier quality, internal audits and management review.
- ISO 13485 and ISO 9001 support
- CAPA and deviation remediation
- Audit-readiness evidence
QA/RA leadership support
Support for medical device quality and regulatory documentation, readiness activities and cross-functional quality delivery.
- MDR/IVDR readiness support
- FDA-related documentation support
- Technical file review support
Audit and inspection readiness
Gap assessments, evidence packs, finding response support and closure planning for regulated teams under review pressure.
- Evidence index
- Response tracker
- Finding closure plan
Regulated documentation
Clear, controlled and audit-ready documentation built around real process use and defensible compliance evidence.
- SOPs and forms
- Controlled records
- Training and evidence packs
Regulated experience timeline
A concise view of the areas of regulated experience that support Sparko’s consultancy positioning.
01
CSV/CSA governance and GxP systems
Experience with GAMP 5, CSA, GxP system validation, validation strategy, template review, system scoping, risk-based assurance, Part 11 and data integrity considerations.
02
Validation lifecycle delivery
Practical delivery across URS, risk assessment, IQ/OQ/PQ, FAT, SAT, RTM, protocol writing, execution support, deviation handling, validation summary reports and remediation.
03
QMS implementation, remediation and audit readiness
ISO 13485 and ISO 9001 aligned support, CAPA, supplier quality, internal audits, complaint handling, QMS implementation, certification readiness and evidence preparation.
04
QA/RA and technical documentation support
Director-level QA/RA responsibilities including MDR/IVDR, FDA, ISO 13485, 21 CFR Part 820, technical documentation, regulatory liaison and inspection/audit support.
05
Regulated life science environments
Experience spans medical device, pharmaceutical, biotech, diagnostics, laboratory and healthcare environments, with support across QA/RA, IT, validation, system owners, SMEs and quality teams.
Why clients work with me
Sparko is designed for regulated teams that need clear, practical and senior-level support.
Practical delivery
Support is focused on usable outputs, clear actions, controlled records and evidence that teams can actually maintain.
Technical validation knowledge
CSV/CSA, GxP systems, intended use, risk, testing, traceability and validation conclusions are handled with technical depth.
QA/RA understanding
Validation and QMS work is connected to regulated quality expectations, technical documentation and audit readiness.
Audit-ready documentation
Documentation is prepared to be reviewed, challenged and defended during audits, inspections and customer reviews.
Works with QA, IT and system owners
Support is cross-functional and can align quality expectations with system administration, process use and technical evidence.
Risk-based thinking
Documentation effort is proportionate to intended use, product/process risk, GxP impact and data integrity significance.
Standards, methods and regulated topics
Support is shaped by the standards, methods and expectations relevant to regulated systems, QMS and medical device documentation.
GAMP 5 and CSA
Risk-based validation and assurance strategy for regulated software, configured systems and electronic records.
ISO 13485 / ISO 9001
QMS implementation, remediation, controlled procedures, records, internal audits and management review support.
21 CFR Part 11 and data integrity
Electronic records, electronic signatures, audit trails, access controls and data-critical system evidence.
MDR / IVDR readiness support
Technical documentation, controlled records, IFU, UDI-related evidence and supplier documentation support.
FDA / 21 CFR Part 820 awareness
Quality-system documentation, audit-readiness evidence and regulated quality process support.
GDP and audit evidence
Good documentation practice, traceable records, evidence control and defensible closeout documentation.
Sectors supported
Sparko supports regulated organisations where validation, quality systems and documentation must be controlled and reviewable.
Medical devices
QMS, validation, QA/RA documentation and audit-readiness support for medical device organisations.
Pharmaceuticals
Validation lifecycle, GxP systems, documentation and evidence support for regulated pharmaceutical environments.
Biotech
Practical compliance support for biotech teams managing regulated systems, processes and quality documentation.
Diagnostics and laboratories
Support for diagnostic, laboratory and controlled-environment documentation, validation and quality-system needs.
Healthcare technology
Support where healthcare technology, electronic records, quality evidence and regulated system use overlap.
Start-ups and SMEs
Focused support for lean teams preparing for audits, go-lives, system validation, QMS implementation or remediation.
Important credibility note
Employer, partner or client names should only be displayed publicly when permission has been confirmed.
Sparko uses “experience gained across roles/projects” wording to avoid implying current client relationships.
Need founder-led CSV/CSA, validation, QMS or QA/RA support?
Send a confidential enquiry with your system, QMS area, validation file, audit deadline or documentation issue. Sparko will help identify the right support route and next steps.