Serialization & Implementation Strategy Plans, Audit Existing Assets, GAP Analysis, Risk Assessment, Resource Planning, Quality Plan, Recommendations Related to Compliance with Evolving Regulations in terms of a target response per regulation and country.
IT Integration and Development
Master data and serialization systems have to be set up in close relation to existing client ERP systems. Middleware systems have to be identified and set up to relate to Manufacturing Site Systems but also to other relevant Supply Chain Partners, like Distributors but also Authorities. At the manufacturing site, line equipment has to be updated with serialization and aggregation capabilities. Information provisioning over the end-to-end business process is a key requirement which implications for data management but also technical connectivity. Validation of the final solution from Enterprise to Site Level – Serialization Validation Strategy & Plan, Serialization Master Validation Plan, Process Validation, Equipment Qualification (IQ/OQ/PQ), Packaging System Validation.
Serialization Awareness & Technology Training Program, Serialization End User Technical Training.
Serialization Technology Evaluations, Development of User Requirement Specification (URS) and Functional Requirements Specification (FRS), System Design Specification, Design Review, e-Pedigree Program Master Planning
Implementation of Project Management, Retrofit Analysis and Implementation, Validation and Qualification Reports, Master Validation Report, Batch Record Review, Implementation of Strategy Plan, Change Control, SOP