Quality and Regulatory in Life Sciences
Products & Services
Quality Assurance and Quality Control
"Quality from R & D to the market-place: Your partner in defining strategies on Quality System implementation and maintenance"

Signifix has expertise and can provide consultancy services in
the following areas:
  • Development of quality system strategies to meet regulatory and quality system requirements, customized to meet specific company needs
  • Development and implementation of ISO/GLP/GMP quality management systems for compliance to required regulatory and quality standards including:

    • Quality System Regulation
      [FDA 21 CFR 820]
    • ISO 13485
    • Good Tissue Practices
      [21 CFR 1271]
    • EU Tissue and Cells Directive
      [DG Sanco: 2004/23/EC, 2006/17/EC and 2006/86/EC]
    • ISO 17025
    • Good Laboratory Practice [GLP]
    • ISO 9001
  • Management of quality system certification and inspection processes, including coordination of audits & inspections by regulatory authorities
  • Coordination of risk management processes using standards such as ISO14971
  • Interim management of QA/QC departments
  • Providing QA advice and support during product design & development activities (design control)
  • Performance of gap analyses, to identify improvement measures for compliance or to improve the efficiency of business processes
  • Performance of internal and vendor audits (domestic and international)
  • Providing QA advice and support in defining and implementing corrective & preventive actions (CAPA) in the case of deviations and quality improvement initiatives
  • Trouble shooting: Effective & efficient problem solving using a hand-on approach
  • Implementation of electronic document management systems
  • Training and coaching: customized training programmes for individuals and groups