Assistance with all stages of control system validation from design requirements through to validated system.
o Control system validation assistance
o GAMP®5 documentation
o Independent documentation / code review
o Test protocols
o 21 CFR part 11 review / remediation
o Data Integrity risk assessment
o Periodic Review
Courses tailored to your products and your audience – whether it is day-to-day users, sales force, project managers or site service engineers.
o Process control systems for GxP envirinment.
o Data integrity.
Management of control systems projects to ensure compliance with GAMP®5 and / or with clients’ internal validation procedures.
Software design, implementation, integration and testing to GAMP®5 or to clients’ internal standards.
o Object oriented analysis
o Clear design documentation
o Structured programming
o Tight change control
o Fully documented testing
o Traceability throughout project