GLP Principles During Project Implementation Phase of Logilab SDMS
Validation
Logilab SDMS has been designed and demonstrated to be fit for purpose in a GLP environment and introduced in a pre-planned manner. The system’s operational validation process during its original product development as well as any project implementation stage includes requirement specification, design documentation, industry coding standards, unit and system testing processes with test documents and reports. Typically, Installation Qualification (IQ) and Operational Qualification (OQ) documents are prepared by Implementation Project Team. While carrying out validation process the complexity and intended use of a system with adequate risk management are considered.
Change Control
GLP principles require laboratories to follow change control process during Computerized system implementation. Change control is the formal approval and documentation of any change to the computerized system during the operational life of the system. It is needed when a change may affect the computerized system’s validation status. Change control procedures must be effective during the project implementation phase as well as after
system go-live. The requirement of proper Support mechanism to be in place is being carefully considered
to ensure that the Logilab SDMS has been used correctly by the end users. The implementation team as well as Agaram’ s Quality Assurance (QA) team work in collaboration with Product Development to resolve any issues encountered during implementation stage. The implemented changes are system tested by QA team and
testing procedure as well as results are documented in test cases.
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