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In the IT system validation field, EXCO boasts specialists with up-to-date quality assurance and technological know-how for safeguarding your IT systems. Our project teams are always put together on an individual basis and process projects relating to SAP, Clarify, ProClarity, Documentum, BPCS, MFGPro, etc. both retrospectively and prospectively.
Benefit from the experience that our employees have accumulated from hundreds of IT projects.
Reduce validation expenditure through a universal risk-based approach (typification of requirements and modularisation of your IT system).
Details of our consulting approach:
- Validation management and project management assistment on the topic of project method and quality assurance
- Risk-based modification of project method in line with the specific requirements of the project (tailoring)
- Content-based definition of project tasks and requirements for documentation in accordance with the customer's IT project method (tasks and deliverables)
- Modification, delivery and coaching of templates used
Execution of project in accordance with customer's IT project method:
- Moderation and evaluation of GxP and security assessment
- Creation of documentation in accordance with deliverable inventory document
- Typification of requirements in accordance with risk classes
- Splitting of system into modules in accordance with risk classes
- Creation of documents, starting and tracking of document workflows
- Test coordination (unit, system, integration, and user acceptance) and reviews
- Documentation for tests
- Creation of status reports
- Creation of phase-related reports (DQ-PQ)
- Creation of validation reports
- Creation of validation registrys
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