Regulatory Compliance and Quality Management

• Design Review/Qualifications
• Validation Master Planning
• 21 CFR Part 11, Electronic Records/Electronic Signature Compliance
• Validation Implementation Planning
• Validation Policies and Procedures
• GxP Compliance Training
• cGMP/Quality Systems Auditing
• Quality Systems Design, Management, Remediation
• Stability Program Design/Implementation.
• Software Supplier Audits.
• Vendor Certification Process Design and Implementation