Enter Project Name Gap Analysis Report Plant – XXXXXXXX
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Revision History 1.0
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Gap Analysis Report – Summary The Gap Analysis is performed from XXX to XXXX for (name site here). The summary is an analysis of a review of documents provided by staff in (name site here). The entire list of documents can be found in XXXX (Name location of a directory). The identified significant gaps have been transferred to a MS Project Plan to be scheduled for completion. This list is not exhaustive and is only remediation activities found to date. Introduction This Gap Analysis is a result of the (name the project here). The (name the project here) is a global project to ensure alignment with global SOPs and current regulatory requirements. Scope The scope of this Gap analysis is limited to (name location here). The entire product range is reviewed for documentation soundness. The scope of the analysis is limited to align documentation from site to site. Objectives The objective of this Gap Analysis is to identify deficiencies within related areas to manufacturing and control of the products XXXXXX division of the XXXX facilities, The deficiencies found to date have been appended to this report in an action plan. The remediation activities will effect re-engineering various areas of work categorised by risk. The diagram in Fig 1.0 indicates the relationship to areas which have been reviewed. Test Method Validation
Test Specifications
Quality Control Plans Test Method
Environmental Monitoring
Validation
Controls Equipment and Processes
Design Inputs and Outputs
Calibration
Design Validation SOP’s and Work Instructions
Gap Analysis Design Review
Design Control Risk Managemement
Procedures
Change Management
Materials
FMEAs
Complaints
CAPA/ NC Material Specifications
Fig 1.0 Brainstorming Mind Map
Shelf Life and Product Stability