ÅF has skilled consultants with quality assurance expertise in a wide range of industrial sectors such as pharmaceuticals, medical device, biotech and food processing. We have experienced QA personnel, regulatory specialists, certified qualified persons (QPs), process development and validation engineers.
We help our clients to meet quality and safety standards, providing solutions that deliver operating and business benefits. We share our knowledge and expertise with clients, giving them access to quality assurance tools that enable them to develop their business, train their staff and use quality assurance as a springboard for business development.
ÅF has high-level expertise and experience in medical technology. We offer services in: Product development (SW, HW and mechanic), Regulatory standards, Risk management (FMEA, CE-standards), GAP analysis, Standards interpretation, etc.
ÅF offers pharmaceutical development, tech transfer and outsourcing know-how to help clients deliver innovative projects in preclinical, clinical, scale up laboratories and in production/process development. Our expertise spans the entire pharmaceutical development process and our consultants have extensive experience in their specialist fields acquired over many years in the pharmaceutical and biotech industry. We can of course provide consultants with GLP/GMP/GAMP5/GDP, etc knowledge.
We help our clients to set up a process or production line, to perform capacity analysis and to integrate quality assurance tools such as LEAN, TPM and 5S.
Quality assurance is a systematic process to guarantee the quality of the items being evaluated. Fundamentally, quality assurance involves a company producing, documenting and following processes in the course of its operations and using various tools to assist in this process.We have experience of working with many excellent quality systems – and we also know what doesn't always work so well. We use our experience to help you build up or improve your existing quality assurance system on a cost-effective basis and in accordance with the applicable standards in your industry.
In regulatory affairs, we assist clients to be in compliance with all rules and regulations relevant to their business. Here we operate in highly regulated sectors such as pharmaceuticals and medical device. We have consultants with experience from supplier audits, inspections from FDA, Läkemedelsverket, etc.
We help our clients to produce a requirements list and/or order for the system they wish to purchase or manufacture.
Validation/test and verification
ÅF has experience in different kind of validations/test and verification of medical device, process equipment, clean room and software-systems. Here we are active in the food processing, pharmaceutical, medical device and automotive industries.Design Qualification (DQ, Installation qualifications (IQ/OQ/PQ), Process validation (PV) Cleaning Validation (CV), Microbiology (MQ), software validation.