Computer Validation

SeerPharma understands the complexities of computer validation. Our goal is to help you to learn about computer validation. Our services include:

• Develop computer validation master plans and identify the most appropriate validation and test strategy to match your application and business needs
• Prepare computer validation policies, procedures and work instructions
• Provide templates for pre-qualification and qualification documentation
• Perform supplier audits
• Develop and execute test protocols
• Perform QA activities overseeing software supplier development
• Conduct IS / IT Gap Analysis studies
• Perform pre-regulatory audit reviews
• Perform 21 CFR Part 11 assessments on systems
• Project manage implementation and upgrades of computerised systems

In addition, SeerPharma provides a range of training courseware that can be tailored for client needs. The trainers are well versed with GAMP guidelines, EU, TGA and FDA regulations with respect to computerized systems validation.