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Validation & Quality Assurance

Improving Safety and Efficiency

From design to decommissioning, ÅF uses a life cycle perspective to improve safety and efficiency.

Any organization involved in industrial production needs to comply with regulatory requirements and ÅF has many years of experience working with validation and quality assurance.

ÅF assists with improving safety and efficiency using a life cycle perspective, from design, development and commissioning to system maintenance and decommissioning.

Examples of core competences:

  • Gap analyses and system evaluations
  • Requirements specifications
  • Validation and quality assurance management
  • Test management
  • Quality and business development
  • Supplier evaluation
  • Cleaning validation

Gap analysis and system evaluation

To confirm cGMP compliance we perform gap analyses on the complete life cycle of production systems and laboratories, from initiation to decommissioning. Our assessments are translated into action plans aimed to ensure improvements are implemented efficiently. We also audit quality systems to confirm GxP compliance.

Requirement specification

Correct and precise requirements specifications are critical for quality improvement and system commissioning. It is also a prerequisite to ensuring requirements are met through every part of the quality assurance process. We are experts in developing requirement specifications, for both technical (instrumentation, equipment, and control systems) and regulatory demands. Our experience has shown that correctly formulated and structured requirements specifications are the foundations of a successful project.

Validation and quality assurance management

Our validation and quality assurance expertise covers all aspects of the life cycle of a production facility from initiation, procurement, and requirements specification to commissioning (DQ, IQ, OQ, and PQ), maintenance, and decommissioning. When validating a system, decommissioning planning is often included in the validation and quality assurance plan. 

Test management

We can offer you management and execution of entire test projects. Our quality management system guarantees a test concept with traceability from requirements specification to system design and test reporting. We are experienced in testing process engineering equipment, cleaning system validation and IT solutions. We can also deploy ValueTrace, an in-house system managing all aspects of documentation for requirement specification, design and testing.

Quality management and business development 

An easy to use, efficient, and correct quality management system lowers the cost of complying with regulatory frameworks. We audit, develop, and implement quality management systems in accordance with industry standards and regulations. 

Supplier evaluation 

Auditing suppliers and their quality management systems is often necessary to minimize quality shortages in an organization. Drawing on broad industry experience, we help you to assess your suppliers and to ensure regulatory compliance.

Contacts

Amy Svalstedt

Amy Svalstedt

Section Manager, Södertälje
+46 10 505 91 94 amy.svalstedt@afconsult.com
Jacob Bergdahl

Jacob Bergdahl

Market Area Manager, Food & Pharma, Stockholm
+46 10 505 27 33 jacob.bergdahl@afconsult.com
Johanna Severin

Johanna Severin

Section Manager, Life Science, Södertälje
+46 10 505 92 35 johanna.severin@afconsult.com
Riham Rafael

Riham Rafael

Section Manager, Quality Assurance & Validation
+46 10 505 73 96 riham.rafael@afconsult.com