OUR EXPERTISE
We are experts
IT & Digital project management
Supervise your projects by providing our expertise in the regulated processes of the health industries and our ability to dialogue with stakeholders.
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validation
Provide proof that the risk induced by a computerized system is under control.
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integrity of your data
Provide and assess the level of security of your data and support you in strengthening it.
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audit
Check the application of regulations, the implementation of good practices and the compliance with the signed contract.
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IT & DIGITAL PROJECT MANAGEMENT
- Project management / project manager / steering assistance
- Needs analysis and selection assistance
- Establishment of requirements
- Risk assessment and risk management
- Management of project actors
- Lean 6 sigma Management
Our knowledge of pharmaceutical, cosmetic, medical equipment processes and our ability to dialogue with project stakeholders, both technical and trades, allow us to support our customers in managing IT & Digital projects.
We can intervene in project management, management or steering assistance. We can also intervene in the analysis/definition of needs and assistance with choice, the establishment of requirements, management of the call for tenders, risk assessment and risk management. In addition, we can support you in the management of project actors.
Validation
- Definition of the validation strategy (VMP, validation procedure)
- Computerized system validation: DQ, IQ, MQ, OQ, PQ
- Risk assessment and risk management
- Preparation of documentation, management of execution, management of anomalies
- Periodic review
- Change management and maintain it in validated state
- Writing of procedures relating to the management of computerized systems (PCA, DRP, backup, administration, etc.)
A computerized system is part of a business process and should not induce regulatory risks on the process in question .
Information systems managing regulatory records must be validated in order to meet regulatory requirements.
This approach also allows users to get to know their system better , if they are fully involved in the project. We support you in validating your information systems by helping you define the validation strategy. We take care of the different validation phases (DQ, IQ, MQ, OQ, PQ) by preparing the documentation, the execution management, the management of anomalies.
DATA INTEGRITY
- Facilitation of training session
- Risk assessment and risk management
- Analysis of regulatory data
- Securing data and infrastructure
Our knowledge of pharmaceutical, cosmetic and medical equipment processes allows us to identify regulatory data in order to enable their mapping and the implementation of the controls necessary to guarantee their integrity.
We can train your teams and show the importance of data integrity. We can help you identify the data and set up all the activities essential to its proper management.
AUDIT
- Internal audit in delegation
- External audit (hosts, providers, subcontractors)
- Methodological audit (validation, projects, data integrity)
Our knowledge of the regulations and best practices allows us to conduct audits of your suppliers, your service providers in order to verify the terms of the contract or within the framework of a choice, to verify the contributions and risks of each.
We are able to make an inventory of data integrity, the compliance of your systems, help you prepare or respond to an audit, an inspection, a Pre Approval Inspection.
Evalu supports you in your audits, both internal and external.
