The process of establishing documented evidence which provides a high degree of assurance that a computer system will consistently meet its predetermined specifications and quality attributes”
- FDA Definition of Validation (adapted for computer systems)

Any system that deals with regulated data is considered to be regulated and must be validated. Examples of regulated data include:

• Any information that is submitted to the FDA
• Any information that can be inspected by the FDA
• Records that demonstrate compliance with Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs) or Good Manufacturing Practices (GMPs)

Because SAP is a highly integrated system, its validation becomes a cross-functional activity that is only successful with the participation of all relevant disciplines including Business, IS, Validation and QA

Specific validation tasks and activities require the knowledge of SAP transactions and system configuration (e.g. Security Profiles and Matrix, Transaction and End-to-End testing, Master Data management and set-up for test scenarios)

• SAP professionals with extensive validation experience
• Validation and QA professionals with extensive SAP experience
• SAP Tester
• Test Automation Experts
• HP Quality Center Experts
• QTP Experts

According to your needs, our experienced consultants will either assist you with or assume complete responsibility for:

• Project planning and management
• Budgeting
• Resourcing (Qualified personnel)
• Project Plan / Validation Plan (Approach, methodology, controls)
  

Preparing SAP specific validation documentation according to Good Documentation Practices including:

• User Requirement Specifications
• Functional Requirement Specifications
• Test scripts
• SOPs
• Security Matrix

We provide training, customized to the needs of the individual stakeholders (QA, SAP Users, IS, Management) including:

• SAP specific Computer System Validation
• 21 CFR Part 11
• GMP
• GDP
• FDA regulation