Computerised System Validation Part-6

Prospective Validation - Supplier Assessment Phase
Supplier assessments determine the level of assurance in the supplier that activities / deliverables equivalent to those outlined in this guideline have been followed/produced for development of computerised systems. The information is used to determine any corrective/additional activities to be undertaken by the supplier in order to address identified deficiencies. The need for follow-up supplier assessments should be commensurate with the number and severity of the identified deficiencies. The validation plan should document applicability and timing of supplier audits. The system category (Managing Hardware and Software) will assist in deciding when an audit is necessary. Supplier audits are most beneficial if they are conducted as part of the supplier selection and procurement process so that any actions arising can be planned and managed as part of the project implementation.
Key areas of assessment are:
• Existence and authority of quality assurance organisation.
• Availability and use of competent people.
• Availability and application of an effective quality management system (procedures and practices).
• Use of programming standards and good practices.
• Effectiveness of testing.
• Availability of a support service (as required)
• Ongoing viability of supplier's business (e.g. financial stability).