The CRO Group is a consulting service provider to a number of software application manufacturers marketing to regulated industries including those in: EDMS, ERP/MRP, PLM, Maintenance, Environmental Monitoring, Risk Management, and Training.
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The CRO Group performs 3rd party GAMP5 and 21 CFR 11 (Part 11) Audits of software applications and their developers and manufacturers. Many of our software manufacturer clients then offer the audit and or Part 11 validation protocols to prospective customers, as well as the complete validation reports.
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The CRO Group can train your development and product management in FDA as well as international requirements and customer expectations for software systems used to supportquality management systems. This includes training in GAMP4 requirements (imposed by most pharmaceutical and biologic/biotech manufacturers, as well as Part 11 requirements.
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