Quality Assurance

In a world where quality and compliance are major challenges, quality assurance consulting stands out as a strategic lever to ensure sustainable and high-performing results. Whether you are an engineer, pharmacist, or involved in another technical profession, Efor supports you in your projects with tailored solutions adapted to your specific needs. Discover how our expertise can enhance your competitiveness.

Our expertise Quality Assurance

System Quality Assurance

Efor experts assist our clients in implementing their Quality Management System and ensure its compliance with regulatory requirements such as GMP/cGMP, GCP, ISO 22716, ISO 15378, ISO 13485/21CFR Part 820, or ISO 9001. Our interventions focus on setting up processes, procedures, or specific quality models in compliance with regulatory environment.

We provide pragmatic and concrete advice on risk analysis, post-marketing surveillance, deviation and CAPA management, and regulatory monitoring, helping our clients achieve the appropriate level of compliance expected by competent authorities.

Finally, our teams of certified auditors provide their expertise in the preparation of audits by notified bodies (GMED, TUV,…), inspections (FDA, ANSM, PMDA, MHRA), or during critical subcontractor audits.

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Operational Quality Assurance

By combining methodological expertise with in-depth knowledge of our clients’ analytical techniques and manufacturing processes, our team of Efor quality assurance experts provide their insights of competent authorities’ expectations in the following areas:
  • Deviation and CAPA management
  • Complaint management
  • Change control management
  • Data integrity analysis and remediation plan
  • Project management for digitalization (implementation and validation of quality software, digitization of batch records, etc.)
  • QHSE expertise (Ergonomics, Certifications, etc.)

Supplier Quality Assurance

Our Efor experts assist supplier quality assurance departments in creating or maintaining dedicated quality procedures, as well as on the following operational topics:

 

  • Management, analysis, and approval of supplier integration or change requests.
  • Implementation and maintenance of Quality Agreements
  • Management of investigations and participation in the analysis of causes of non-conformities
  • Support in the improvement or management of CAPA systems implemented to resolve supplier non-conformities.
  • Participation in periodic supplier evaluation committees
  • Management of continuous improvement activities focused on supplier quality

 

 Our Audit Center also offers partial or complete outsourcing solutions for supplier quality assurance activities. 

 

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Quality Control

At the core of quality control laboratories, our Efor expert teams offer both operational support and strategic guidance. Our experts support the phases of ramp-up and operational management of laboratories. They also bring their expertise in managing transformation and digitalization projects, including:
  • Transition management
  • Organization and life of the laboratory in accordance with GMP and HSE rules
  • QC release, maintaining and monitoring deadlines, implementation and monitoring of KPIs
  • Management and monitoring of OOS, OOT, Deviations and CAPA
  • Backlog analysis processing
  • Analytical assistance to production
  • Development, validation and transfer of analytical methods
  • Support for transformation projects (implementation and validation of LIMS, strategy for standardization of analytical methods for digitalization, etc.)

Which sectors benefit from our expertise?

Efor Group operates across numerous industries, implementing tailored solutions to meet the specific requirements of each field. Here are the main sectors where our expertise applies:

  • Pharmaceuticals: Ensuring product compliance with current standards and regulations.
  • Biotech: Supporting innovations throughout their lifecycle, from research to commercialization.
  • Medtech: Optimizing processes and ensuring the safety of medical devices.
  • Cosmetics: Guaranteeing product quality within a strict regulatory framework.
  • Consumer Health: Supporting the production of consumer health products while adhering to quality standards.
  • Global Industries: Enhancing industrial system performance through tailored tools and rigorous indicator management.

With a team of passionate and skilled experts, Efor is committed to implementing innovative and effective solutions to address the challenges of each sector.

The Challenges of Quality Assurance Consulting

  • Development: Efor supports businesses in their growth by securing the launch of new products or services through tailored solutions that meet the specific requirements of each market.
  • Operations: Our experts are dedicated to ensuring control over internal and external processes by identifying weaknesses, anticipating risks, and implementing appropriate measures for optimal management.
  • Continuous Improvement: We foster a culture of continuous improvement by analyzing key performance indicators, optimizing processes, and enhancing customer satisfaction to maximize competitiveness and results, aligned with your company’s strategy.
  • Compliance: Efor ensures adherence to constantly evolving standards and regulations, while integrating digital tools to simplify and strengthen compliance process management.
  • Transformation: We support businesses in adapting to complex environments by accelerating innovations, securing transitions, and effectively managing organizational changes.

Our interventions

  • System

    The implementation and certification of a Quality Management System (QMS) according to ISO 13485 are key steps in accessing the European market. Drawing on various experiences gained, our experts support our clients in structuring and maintaining their QMS in accordance with the expectations of competent authorities.
  • Non-compliance

    In the pharmaceutical industry, the management of non-compliances (NC) is essential in order to comply with GMP requirements. Our experts have been able to provide their skills to ensure the optimal management of NCs and associated CAPAs before and after regulatory authorities inspections.
  • Transition

    In case of events impacting our clients’ Quality Control laboratories, our experts intervene as transition managers to ensure operational management, release of finished products, or to lead transformation or digitization projects.
  • Suppliers

    Supplier management is a key element in meeting regulatory requirements for traceability. Our experts have been able to provide their skills in qualifying and auditing our clients’ critical suppliers, as well as in the establishment and management of Quality Agreements.
  • Laboratory

    For a cosmetics industry client, our experts were able to perform a diagnostic of the ex-vivo testing facility and propose an action plan to ensure the acquisition of GLP certification.

« We aim to consolidate our position as specialists in securing healthcare products ».

– Dienabou BAH – Quality Department Manager

Why Rely on Qualified Experts?

In a constantly evolving environment, businesses must adapt quickly to new market demands. Turning to quality assurance experts offers numerous advantages:
    1. Mastery of Standards and Regulations:: Industry experts have in-depth knowledge of applicable standards and best practices to adopt, ensuring compliance and reducing risks.
    2. Optimization of Internal and External Processes: They identify weaknesses and propose tailored solutions for improvement, enhancing efficiency and productivity.
    3. Performance Indicator Monitoring: Using modern tools, experts analyze results and work towards ensuring continuous improvement in operations and outcomes.
    4. Strengthening Professional Skills:Every team member, whether an engineer, technician, or pharmacist, benefits from personalized support to develop their skills and expertise.
    5. Enhanced Customer Satisfaction:Delivering optimal quality in products and services helps retain customers, build loyalty, and strengthen the company’s brand image.

A Comprehensive Approach at Every Stage

Quality assurance is involved in every stage of a project’s lifecycle, from design to disposal, including maintenance. It relies on structured methodologies, regular audits, and rigorous management of non-conformities. Efor’s experts work collaboratively with internal and external teams to ensure sustainable results that meet expectations.

Tailored Solutions to Meet Your Needs: Why Choose Efor?

Efor offers a wide range of services, from technical assistance to Full Service solutions. Our experts monitor key performance indicators and take action to ensure optimal results.
Whether you are a small business, a medium-sized enterprise, or a large corporation, our customized support is designed to align with your ambitions and requirements. By choosing Efor, you are opting for a committed partner capable of addressing your specific needs while adhering to regulatory and operational constraints.
So, why not leverage our expertise to turn your challenges into opportunities?

Want to learn more?

Contact us today to discover how our solutions can meet your quality and compliance needs.
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