Computer System Validation – 21 CFR Part 11
The progressive substitution of paper by electronic registers in dTC services in CSV:
regulated environments as the pharmaceutical one makes it
necessary to assess computer system compliance with The activities supplied by dTC in the field of validation and
regulations. qualification of the IT services that manage regulated activities try
to cover two basic objectives:
Infraestructure qualification provides documented evidence of the • Compliance with GMP´s, GLP´s and 21CFR Part 11.
reliability, security and integrity of the LAN/WLAN or WAN • To assure the control of the IT environment during
environment. routine use.
Implementing simple, effective and risk based mechanisms
associated to the infrastructure and computer systems and the
most recent recommendations of professional organisations
(GAMP, ISPE, DIA, etc.)
• Validation Master Plans of Computer Systems and
• Recommendations on the selection of system suppliers
for regulated activities.
• Compliance with 21 CFR Part 11 - GAP analysis.
Execution of the qualification - validation:
• Elaboration of the necessary documentation for the
The goal of Computer System Validation activities is “The project dossier and/or evaluation of existing
demonstration that a computerised system is suitable for its documentation.
intended purpose”. (The Application of the Principles of GLP to
Computerised Systems. OECD, 1995). • Audit of IT solutions suppliers.
The validation effort has to be commensurate to the criticity and • Use of customized risk analysis tools to determine the
complexity of the computerised system itself. extent of the validation and/or qualification effort.
• Performance of the validation activities according to the
client's needs (from solution "key in hand", to support
for individual activities).
On going or recent projects
- Computer System Validation for the control system of
lyophilisation equipment (GMP - 21 CFR Part 11).
- Computer System Validation for the control system of a
vial labelling equipment (GMP - 21 CFR Part 11).
- Validation of a management system for analytical
instrumentation in a LAN environment (cGMP - GLP - 21
CFR Part 11).
- Computer System Validation for an environmental
monitoring system (GMP - 21 CFR Part 11).
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