Aims
To ensure that all compliance audits by customers are successful and any orders depending on those audits are retained with no cancelllations.
Role
Lead auditee and subject matter expert
Key Points
- Act as the first point of contact for all customers requesting to audit the business.
- Act as subject matter expert for all audits.
- Develop white paper for 21 CFR Part 11 compliance of software products.
- Develop a knowledge base for the completion of all pre-audit questionnaires.
Successes
- No cancelled orders
- Extra orders gained
- No major nonconformances
Skills
- Compliance knowledge
- Understanding customer requirements (mainly pharma industry)
- Presentation skills
- Extensive internal process knowledge
- Ability to tailor answers to respective clients in their terminology.
- Open and honest approach
Tools used
- Teleconferencing tools