||Nalco SAP System Validation Details:
• Extension of Plant/Warehouse through standard configuration.
• No custom changes required.
• No data implications. Only the extension of material to the new plant/warehouse.
• User to access (standard SAP transactions) the system through remote accesses.
• No Hardware/software installation.
SDLC Deliverables and Control:
• User Requirement: to be documented. This should elaborate the need and also the identification of regulatory implications.
• Configuration Document : Update/create the configuration document with the details of plant/warehouse extension.
• Test Plan : Test Plan to detail out the testing strategy. We don’t need extensive Test Plan document but only to cover the scope of testing, security, migration path, Identification of test scripts and how the testing will be
recorded. It will be important to establish some testing protocols to ensure the controls on the testing processes.
• Testing : Testing in control environment and recording of test results with objective evidences. We can use HP ALM (which is a validated system) to record the testing and related. This will also help streamline the testing
for any such developments.
• Test Report : A test Report to summarize the testing activities. A traceability of user requirement to the testing can also be documented here. This document can also serve as the consent from all stake holders for fitment
of use of the process.
• SOP/Work Instruction: Identification, creation of SOP for each process.
• Role based training.
Role : Computer System validation/IT Compliance Specialist.
Validation experience: in SAP environment 6-10 years.
SAP Experience: 4-6 years.
• Extensive experience in Computer System Validations (CSV) ensuring legislative compliance in GxP environment for many critical modules/systems.
• Develop, implement and manage a comprehensive ITQ deliverables (URS, FS, DS, Test Plan, Test Report, Traceability Matrix, SOPs. Experience in writing SOPs, validation protocols.
• Work with internal/external teams.
• Coordinate validation efforts within the Quality System Regulation (21 CFR Part 820), Electronic Records; Electronic Signatures (21 CFR Part 11)
• Extensive experience on 21CFRPart 11, 820 compliance on critical projects.
• Experience in preparing, enacting, enforcing across different teams and ensuring deliverables completion conforming to various FDA regulations.
• Oversee experience to ensure adherence to IT policies, procedures and industry standards and best practices, IT Guiding Principles.
• Good communication skills (verbal and writing), Team Management skills.