Quality Assurance

Efor provides its Life Sciences industry clients with concrete support for the implementation, optimization, and compliance of their organizations and quality systems with regulatory and normative requirements in Europe and internationally.

Contact our experts

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.

Contact our auditors

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. 

 

Contact our auditors

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.)

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

Our trainings

Our on-site trainers skillfully and pragmatically enhance our clients’ expertise in accordance with technical, regulatory, and quality challenges, while making the learning process enjoyable.

Discover our trainings

Our business fields

Our specialists offer tailored solutions in the field of Life Sciences and Global Industries.

Discover our industry sectors

Join the adventure

More than just a resume, we are looking for personalities. Reveal your talent at Efor.

Welcome home