CONSULTANCY

Assistance with all stages of control system validation from design requirements through to validated system.

o Control system validation assistance

o GAMP documentation

o Independent documentation / code review

o Test protocols

o 21 CFR part 11 review / remediation


TRAINING

Courses tailored to your products and your audience – whether it is day-to-day users, sales force, project managers or site service engineers.

o GAMP familiarisation

o 21 CFR part 11 awareness


PROJECT MANAGEMENT

Management of control systems projects to ensure compliance with GAMP and / or with clients’ internal validation procedures.

SYSTEMS INTEGRATION

Software design, implementation, integration and testing to GAMP 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