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Introduction
In a constantly changing environment, respect for regulatory standards And requirements of prime contractors (OEM) is a major challenge for manufacturers. Regulatory frameworks are becoming more and more complex, requiring greater rigor at each stage of the product life cycle. To meet these challenges, manufacturers must rely on solutions capable of integrating compliance in a fluid, sustainable and scalable way.
This article highlights the strategic role of product lifecycle management (PLM) software as a key tool to effectively manage compliance, while guaranteeing the traceability, operational efficiency and by simplifying the audit preparation.
Compliance challenges in modern industry
The complexity and extent of regulatory requirements continue to grow. Manufacturers must deal with a variety of standards such as ISO certifications, the EN, AS and EASA standards for aeronautics, The IATF for the automobile, or even the directives MDR and FDA for medical devices. In this context, compliance is no longer an option, but a strategic necessity.
In addition, there are specific OEM requirements : detailed documentation package, rigorous quality control and complete traceability of product life cycle data. Even the smallest breach can have serious repercussions: financial penalties, product recalls, reputational damage, or business interruptions.
In addition, the complexity of industrial products, the longevity of their life cycles and the depth of supply chains are further increasing the pressure borne by manufacturers.
Faced with this growing complexity, manufacturers must equip themselves withmodern tools capable of guaranteeing a strict traceability and to insure compliance with the various applicable standards.
How PLM software ensures the conformity regulatory
One PLM software Constitutes a single source of truth for all data and processes techniques. By connecting design, industrialization, manufacturing, quality and support teams within the same environment, it promotes consistency of information, insure the traceability and improves collaboration between departments.
A modern PLM solution allows manufacturers to:
- Centralize technical data — specifications, CAD files, schedules, instructions, procedures, quality documents — in order to eliminate silos and ensure access to up-to-date information.
- Guarantee complete traceability by ensuring accurate monitoring of data, processes and their evolutions. Each change is approved and trackable.
- Automate change management thanks to workflows that make it possible to digitize requests, impact analyses, change processing, validation circuits, electronic signatures and intelligent data distribution.
- Optimize configuration management by giving operational teams the ability to manage product versions and their evolutions, with a clear vision and the history of each stage.
- Simplifying audit preparation thanks to structured data that can be consulted and exported at any time.
In summary, the PLM integrates compliance in daily operations, making it more fluid, proactive and less restrictive. It allows manufacturers to reconcile compliance with standards, operational efficiency and capacity for innovation.
The benefits of a PLM strategy focused on compliance
Adopt a compliance-oriented PLM strategymeans choosing a company that is more resilient, more agile and better equipped to seize opportunities in highly regulated markets. The benefits are both tangible and strategic:
- Reducing the risks and costs of non-compliance: the complete traceability of data and the early identification of non-compliance risks make it possible to avoid penalties, product rejections or recalls and regulatory disputes or complications.
- Accelerating time-to-market: PLM streamlines product development processes, prevents information loss, reduces rework and accelerates validation cycles, thus allowing faster and controlled launches to market.
- Strengthening competitive advantage: by relying on structured processes and documentation, manufacturers gain legitimacy in regulated markets, inspire trust and open the way to new business opportunities.
Key criteria for choosing a PLM
The choice of PLM software is crucial for ensuring compliance effectively without burdening internal processes. An efficient PLM must offer great configuration flexibility to adapt to regulatory requirements and the specific requirements of contractors.
It should allow the creation of customized workflows in order to manage complex processes in an intuitive, structured and auditable way. Digital change management - integrating change requests, impact assessments, impact assessments, validations, electronic signatures and data dissemination - considerably increases the responsiveness of teams. This improves transparency, traceability, and processing times.
The smooth integration of PLM with existing tools such as CAD or ERP is also essential to ensure real-time synchronization and digital continuity of data.
The solution Aletiq Next Generation PLM was designed to meet all of these challenges. Thanks to his intuitive interface, to his interoperability with business tools, at its digitalization of workflows configurable and at the full traceability, Aletiq allows manufacturers to effectively comply with regulatory standards such as ISO, EN, AS, IATF, MDR and FDA, as well as strict OEM requirements.
Conclusion
Integrate a PLM in compliance management is no longer an option, but a a real driver of performance and competitiveness for industrialists. By adopting modern solutions like Aletiq, businesses not only ensure compliance with regulatory requirements, but also strengthen their operational efficiency, make collaboration more fluid between teams and secure their position in demanding markets.
Do you want to find out how the Aletiq Next Generation PLM can transform your compliance approach? Click here to schedule a demo with one of our experts now.
To go further: join our webinar!
Rendezvous May 20 at 9 am for a live exchange.
Anne-Delphine Beaulieu, Chief Digital Officer of Lisi Group, and Geoffrey Ricard, Co-founder and CEO of Aletiq, will share their vision of the role of PLM in regulatory compliance, through concrete feedback.
During this session, you will also have the opportunity to ask all your questions to the speakers.
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