At Affinity, we fully understand how regulatory requirements can appear difficult to decipher and interpret.

One of our fortes at Affinity is taking complex regulatory requirements, and transforming them into easy to use operating systems.

Along with our service delivery, we enjoy working with people, naturally mentoring and guiding, such that we are adding knowledge to your organization and enabling your people for the future.

We deliver a professional, thorough service, striving always to exceed your expectations.

Allow us at Affinity to add value to your organisation and enable you and your team for the future.

We provide formal training courses and mentoring programs, which can be tailored to suit your needs, in several topics including:


  • Risk based Validation of Equipment and Computerized Systems
  • Use & Practical controls of E-records and E-signatures (21 CFR Pt11 & Annex 11)
  • Auditing your QMS
  • Successful External Audit management