GxP Compliance

Vyana Healthcare Limited delivers digital transformation consulting for regulated pharmaceutical, biotech and healthcare environments. Every engagement is designed to uphold GxP (GMP, GLP, GCP, GDP, GVP) standards and the data integrity expectations of global health authorities.

Our consultants design and implement systems aligned with the following frameworks across MES, serialisation, ERP integrations, LIMS, QMS, and data analytics platforms:

• EU GMP Annex 11 - Computerised Systems
• US FDA 21 CFR Part 11 - Electronic Records & Signatures
• ICH Q7, Q9, Q10 - Quality Risk Management & Pharmaceutical Quality Systems
• ISPE GAMP 5 (2nd Edition) - Risk-based approach to GxP computerized systems
• ALCOA+ Data Integrity Principles
• EU FMD & US DSCSA - Serialisation and Track & Trace
• ISO 13485, ISO 27001, ISO 9001

We support the full Computer System Validation and Computer Software Assurance lifecycle: User Requirements, Functional and Design Specifications, Risk Assessment, IQ/OQ/PQ, Traceability Matrices, and ongoing Periodic Review.

Our approach is risk-based, leveraging GAMP 5 (2nd Edition) and FDA's CSA guidance to focus validation effort on patient safety, product quality and data integrity.

All MES, serialisation, ERP, LIMS and analytics solutions we deliver are designed so records remain Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available.

We embed audit trails, role-based access, electronic signatures, and review workflows into system configurations from day one.

Project deliverables are produced under documented quality procedures covering version control, change management, deviation handling, and supplier qualification.

We collaborate closely with client Quality Assurance teams to align our delivery artefacts with the receiving Pharmaceutical Quality System.

When platform vendors or sub-processors are involved (e.g. MES, ERP, cloud, analytics), we support supplier audits, qualification questionnaires, and quality agreements as required by GxP regulations.

Engagement data is handled under strict confidentiality and information security controls aligned with ISO 27001 principles, with role-based access, encryption in transit, and secure collaboration workspaces.

Vyana Healthcare maintains active engagement with industry bodies (ISPE, PDA, GAMP CoP) and continually updates our methodology to reflect evolving regulatory expectations, including FDA's CSA, EMA guidance, and Industry 4.0 quality models.

For GxP, validation or compliance questions related to an engagement or proposal, contact: Vyana Healthcare Limited, Galway, Ireland. Email: msidhapurker@gmail.com. Phone: +353 871 098 721.