Securereliablescalableand cost-effective solutions for GxP and non-GxP environmentsand cost-effective solutions for HIPAAGxPand non-GxP environmentsVendor assessment and remediationRegulatory compliance assessments (Annex 1121 CFR 11GDPRHIPAASOX)Cloud computing (AmazonGoogleMicrosoft)Infrastructure qualification (on-premise networksdata centers)Policy and procedure developmentSDLC (AgileScrumGAMP 5)Data analytics and business intelligenceData integritysecurityand business continuityRole-based training (Annex 1121 CFR 11GDPRHIPAASOX)Technology frameworksRegulatory compliance frameworksValidation of computer systemsGxP computer systems (ELNLIMSEDCdocument managementpharmacovigilance)non-GxP computer systems (CRMERPbusiness intelligence)Risk assessment and remediation