Main Reasons for the Update:
- Lack of structured lifecycle management for equipment and systems.
- Frequent violations of data integrity rules, posing major risks as the generation of large amounts of data becomes increasingly important.
- Better alignment with GDPR, 21 CFR Part 11, and other best international practices.
- Interfaces between systems and cloud solutions have become standard in the pharmaceutical industry.
Een praktische benadering van oorzaakanalyse
Productie- en kwaliteitsteams escaleren het probleem onmiddellijk. Leidinggevenden van de steriele productie komen bijeen om de situatie te beoordelen en er worden dringende beslissingen genomen. Vaak worden de ruimtes waar de APS werd uitgevoerd in quarantaine geplaatst. De commerciële steriele productie mag alleen doorgaan totdat de lopende batches zijn voltooid, maar er worden geen nieuwe batches gestart totdat de oorzaak van het positieve APS-resultaat is vastgesteld.
Meestal wordt er een speciale ‘war room’ ingericht en wordt er een team van materiedeskundigen (SME's) en kwaliteitsvertegenwoordigers samengesteld om het onderzoek te starten.
What are the Changes in Eudralex Volume 4 Annex 11:2026?
- Stricter requirements for Data Integrity and ALCOA+ principles: Data Integrity and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) are described in Annex 11. The importance of audit trails and their validation must be demonstrated, as well as the interfaces between systems. Archiving and backup of data must be proven.
- Access Management: Access control will become a key pillar. Companies must have access controls according to roles. Critical installations may only be accessed via multi-factor authentication. Access management must be periodically reviewed.
- Electronic Signature and Verification: Electronic signatures must be linked to the unique user, with traceability to the time and date of signing. Shared accounts or insufficient verification are not allowed.
- Mandatory Full Lifecycle Management: Companies must demonstrate full lifecycle management of systems. Systems must be validated before use, with periodic validation and maintenance to ensure the system remains in a validated state during use, changes, and maintenance. Decommissioning of systems is described, with emphasis on maintaining data integrity.
- Supplier Oversight: The client remains responsible for outsourced services. For example, with cloud applications, GMP responsibility remains with the client. Supplier audits must be performed and suppliers qualified. Contracts and Service Level Agreements (SLAs) must include requirements for data integrity, availability, and decommissioning.
- Archiving, Backup, and Data Retention: Data lifecycle management will become an important part of organizational policy. This includes demonstrating readability and integrity, ensuring cloud backups are secured and tested, and documenting these requirements in contracts.
- Periodic Evaluations and Change Control: Companies must conduct periodic evaluations, and demonstrate system performance, validation status, and security updates. Change control for software changes and configurations must be assessed and documented.
Impact on Your Organization
Due to the update of Eudralex Volume 4 Annex 11, your organization will need to perform a GAP analysis on current processes and systems. Procedures, contracts, and SLAs must be reviewed. Staff in QA, IT, and operations roles must be trained in the new requirements. QA and compliance teams are responsible for validation, audits, and ensuring quality.
Which Departments Will Be Impacted?
The GMP responsibility (direct) applies to pharmaceutical companies. In addition, manufacturers of medical devices and biotech companies must adapt their processes. Suppliers of cloud solutions and software will face stricter requirements from their clients.
As Nomec Advipro, we can assist you in performing a GAP analysis. Our Senior Consultants and GMP specialists are available to discuss the possibilities. In our GxP Academy, we also offer a CSV/CSA training that provides a good understanding of how computer system validation should be set up and what the requirements are.
Meet Normec Advipro Expert: Alain Deloof
Alain Deloof is the Operations Unit Director of Academy & Consultancy at Normec Advipro, bringing extensive expertise in cleanroom construction, GxP compliance, and quality systems within highly regulated industries.He has a proven track record of leading complex projects from concept to implementation, with strong experience in risk management, budget control, and the coordination of cross-functional teams. Alain is also an experienced auditor and strategic advisor, supporting organizations in achieving and maintaining regulatory compliance, including Good Manufacturing Practice (GMP), ISO 13485, and Computer System Validation (CSV).In his role as Operations Unit Director of the GxP Academy, Alain is responsible for the development and delivery of high-level training programs covering GMP, cleanroom operations, aseptic techniques, quality risk management, and CSV. Through these initiatives, he helps organizations strengthen internal expertise, enhance compliance, and improve inspection readiness.
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable guidance. Thanks to our extensive expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
Related services
Related articles
28 Apr 2026
A Failed APS: Every Sterile Production Department’s Nightmare
A failed aseptic process simulation (APS) is every sterile production department’s nightmare. As soon as the culture medium becomes cloudy, alarm bells go off throughout the entire organization.
05 May 2025
Advipro Becomes Normec Advipro
Lille, May 5, 2025 – Advipro, an expert in consulting and project support within the life sciences sector, is taking a new strategic step. Starting in May 2025, the company will operate under the name Normec Advipro.
13 Sep 2024
Winter Mapping: Protect Your Temperature-Sensitive Products
Discover how mapping works and why it’s essential for addressing the challenges posed by controlled environments. We’ll outline the best practices for effective winter mapping.
31 Aug 2022
Where Can Normec Advipro Make a Difference? | PIC/S Standard
A new Royal Decree was recently published “concerning the preparation and dispensing of medicines and the use and distribution of medical devices within healthcare institutions.” You can read all about it in the blog “The New Regulations for Hospitals and Their Pharmacies.” Specifically, the regulations require work to be carried out in controlled environments (cleanrooms), where the handling of open containers must always take place in ventilated rooms with filtered air. For many hospitals, building and validating a cleanroom is a major undertaking, and they often lack the necessary in-house expertise. Collaborating with an expert like Normec Advipro offers enormous benefits. We work closely with the hospital and apply the “First Time Right” principle, which benefits the project’s quality, budget, and timeline. In the past, we’ve collaborated with various large and small hospitals, as well as university hospitals. Below, we outline a few project phases in which Normec Advipro provided real added value and share our three main lessons learned.
24 Feb 2022
5 Reasons to Choose a Career in Life Sciences
Choosing a career in pharma & life sciences is a forward-looking choice in a rapidly growing industry. But you must also make a conscious decision to enter this highly regulated and state-of-the-art sector.
16 Jun 2025
Summer Storage: Protect Your Temperature-Sensitive Products
Discover how mapping works and why it’s essential for addressing the challenges posed by controlled environments. We’ll outline the best practices for effective summer mapping.
24 Feb 2022
What is GxP?
Sooner or later, everyone comes into contact with medications, but we often don’t stop to think about everything that needs to be done to safely deliver a medication to the patient. When it comes to medications, patient safety is paramount. To ensure safety, various quality systems have been introduced in the pharmaceutical and food industries. These quality systems are divided into different categories. The general term for these quality systems is GxP. What does GxP mean, and why is it so important to implement quality systems in these industries?