GxP quality, validation and Veeva Vault services for biotech
Fixed price and fractional GxP services for small biotech, from the Bay Area.
Fractional Veeva Vault administration
Configuration, user and security management, lifecycle and workflow design, release impact assessment and system maintenance across QMS, QualityDocs, RIM, eTMF, CTMS and PromoMats.
Details and pricesCSV and CSA validation consulting for biotech
Risk based validation strategy, validation plans, URS/FRS, IQ/OQ/PQ, traceability, summary reports, periodic review and change control, aligned with 21 CFR Part 11 and GAMP 5.
Details and pricesGxP project management for Veeva Vault and quality system rollouts
Hands on implementation project lead, from requirements to go live: stakeholder alignment, vendor coordination, cutover and hypercare.
Details and pricesVeeva Vault configuration and enhancements
Configured, tested and change controlled changes to your Vault, from a single workflow to a new module.
Details and pricesIndependent CDMO, CRO and GxP vendor audits
Supplier qualification and GxP system vendor audits, with findings, CAPA follow up and risk based oversight.
Details and pricesInternal GxP audits and FDA inspection readiness
Internal QMS audits and mock inspections across Change Control, Deviation, CAPA, Audit Management, Document Control and Training.
Details and pricesVeeva Vault validation for biotech
Fixed price Veeva Vault validation for small biotech: initial validation and release impact assessments.
DetailsVeeva Vault implementation for biotech
QMS, QualityDocs, eTMF, CTMS, RIM and PromoMats rollouts for lean biotech teams.
DetailsPaper and legacy quality system migration
Paper or legacy quality processes moved into validated Veeva Vault QMS, QualityDocs or eTMF.
DetailseTMF inspection readiness and sponsor oversight
TMF audits, QC and CRO oversight evidence aligned to ICH E6(R3).
DetailsCommercialization and pre approval inspection readiness
Commercial systems and processes, data integrity and supplier readiness for BLA and NDA filings.
Details