We understand the approach required for automated systems and information systems. For new systems we will work with your supplier, making as much use of their internal quality system as the basis for qualification. User requirements and system and functional specifications are developed and incorporated into the necessary test scripts. For legacy systems, we will evaluate risks and develop a remediation plan. We understand the requirements of Part 11 and can validate electronic records and electronic signature functions as part of the qualification effort.
Although not requiring an entirely different approach from equipment systems, automated systems do present some unique requirements in the approach to the validation life cycle. Early in the planning stage, the user requirements must clearly detail everything that the system must accomplish. The supplier must provide a functional specification detailing how this system will satisfy the user requirements. Design reviews must ensure that the system as specified will satisfy the requirements.
The supplier’s internal quality system can be used to support the qualification process. Software module testing through system acceptance testing in the development and integration phases should be thorough enough to work out bugs before entering the qualification activities and include testing of the specifications and functional specification.