Pilot, connect and optimize your industrial systems with expertise.
Pilot, connect and optimize your industrial systems with expertise.
Audit - EVERDYN
Do you want to improve your AVEVA / Wonderware application but don’t know where to start? Have the speed and stability of your application audited by a team of experts!
In an industrial environment, the reliability and performance of supervision and data management systems are essential to ensure production continuity. Our AVEVA solutions audit service allows you to assess the state of your installations, identify technical risks and optimize the overall operation of your industrial systems. They are there to establish the actions and priorities of a site. It is essential to know where you stand in order to plan for the future.
Find out all about our audit
If you find yourself in these situations:
- You have tried several approaches to improve your application, but you are stuck, or worse, you don’t know where to start.
- You need someone to tell you what needs to be improved.
- You need help to quickly achieve better performance.
Why order an audit of your application?
Our application audit reviews all the dysfunctions of your current system. It opens your eyes to new strategies you haven’t yet considered — strategies that will make your application more efficient. Our team of experts will thoroughly analyze your application’s performance, its design and structure, your core development practices, and much more.
If there’s a problem, we’ll find it. And we’ll explain exactly how to fix it.
We work on existing architectures to provide a clear, objective and operational view of their performance, security and maintainability ?
- Assess performance and reliability
- Analyze architecture and technical performance
- Verify cybersecurity and system compliance
- Optimize the maintainability and sustainability of installations
- Concrete, results-oriented support
At the end of the audit, we provide a clear and actionable report for technical teams and industrial managers.
This report includes:
- A detailed diagnostic of the existing system
- Identification of risks and critical points
- Prioritized technical recommendations
- An improvement action plan
- Optimization or modernization proposals
- An estimate of operational impacts
Our goal is to provide a pragmatic and directly applicable vision in the field.
Our audits enable an in-depth inspection and provide expert opinion on:
- Infrastructure
- Configuration
- Security
- Disaster recovery plan
- System performance
- Documentation
- Compliance with Wonderware and development best practices
- Operational risks
21 CFR Part 11 Compliance and Data Integrity
We carry out technical and regulatory audits adapted to the requirements of pharmaceutical and biotechnological environments subject to good manufacturing practices, in particular the Good Manufacturing Practice frameworks.
In the pharmaceutical industry, the control of computerized systems and data integrity are essential requirements to guarantee product quality, operational traceability and regulatory compliance. Our regulatory audit service supports industrialists in the evaluation and compliance of their automation and supervision systems with the requirements of 21 CFR Part 11 regulation and the Data Integrity principles defined by health authorities, in particular the U.S. Food and Drug Administration and the European Medicines Agency.
We work on critical industrial systems to ensure the reliability, security and compliance of data used in pharmaceutical production processes. Assessing the compliance of industrial computerized systems — our audits aim to verify that industrial systems meet regulatory requirements in terms of electronic data management, traceability and security.
Assess the compliance of industrial computerized systems
Our audits aim to verify that industrial systems meet regulatory requirements in terms of electronic data management, traceability and security. We analyze in particular the following systems:
- Supervision systems (SCADA / HMI)
- MES and production management systems
- Industrial data historian systems
- Programmable logic controllers and data acquisition systems
- Industrial IT infrastructures (servers, networks, backups)
- Interfaces with quality and ERP systems
The objective is to identify regulatory gaps and potential risks that could compromise compliance or data integrity.
Data Integrity Audit according to regulatory best practices
Data integrity is a fundamental pillar of regulatory requirements in the pharmaceutical industry. Our audits are based on internationally recognized principles, in particular the ALCOA+ Principles framework.
Verification of 21 CFR Part 11 requirements
Our audits cover the specific requirements related to the management of electronic records and electronic signatures in industrial systems. We verify in particular:
- User account and role management
- Implementation of electronic signatures
- Traceability of user actions (audit trail)
- System access security
- Validation of computerized systems
- Backup and restoration management
- Protection against unauthorized access
- Change management (change control)
These verifications ensure the regulatory compliance of systems used in GMP environments.
A structured and compliance-oriented audit
Our audit methodology is based on a rigorous and documented approach, compatible with regulatory requirements and authority inspections.
Our approach:
- Analysis of the scope and systems concerned
- Documentary and regulatory review
- Technical and functional audit on-site or remotely
- Identification of compliance gaps (gap analysis)
- Assessment of regulatory and operational risks
- Development of a corrective action plan
When should a Data Integrity regulatory audit be carried out?
An audit is particularly recommended in the following situations:
- Before a regulatory inspection (FDA, ANSM, EMA)
- When implementing a new industrial system
- After a software migration or upgrade
- As part of a Data Integrity compliance program
- Following a quality audit or a major deviation
- During a digitalization or automation project
Our technology experts are capable of programming equipment from leading suppliers such as Schneider-Electric, Aveva, Siemens and many more.
Our experts are not only technology specialists, they also possess in-depth knowledge and extensive experience across many industrial sectors, including Food & Beverage, Consumer Packaged Goods (CPG), Automotive, Metallurgy and Energy Production.
Turnkey projects or consulting
We can carry out audits, studies, design detailed specifications or provide maintenance for any type of automated system, whether in the context of consulting activities or fixed-price projects.
