Viroclinics has adopted a high quality standard in all operations, testing procedures and reporting. The quality management system is based on NEN-EN-ISO 15189, GLP and expanded with elements of GCP, to comply with regulatory requirements and facilitate regulatory submissions. It is accredited by the Dutch Accreditation Council (Raad van Accreditatie) which audits and visits the facilities on an annual basis. Moreover, the quality standards are monitored using an internal auditing scheme and the facilities are regularly audited by customers and contract organizations. The standard operating procedures and validation reports will be made available to contracted sponsors upon request.
In more detail:
- Training of sufficient employees to ensure redundancy in case of illness or other absence. Functions are substitutable as defined in a formal substitution matrix.
- Protocols are validated prior to release, and subsequently monitored and maintained on a regular defined basis. Moreover, the quality is monitored based on trending positive controls, conducting proficiency tests and performance of internal in-process audits.
- Equipment is validated prior to release, and subsequently monitored and maintained on a regular defined basis. Additionally there are multiple instruments for all the needed equipment. In the unlikely event of a breakdown, or unforeseen delays in maintenance, alternative equipment is available for continuation of the protocol.
- Temperature-regulating equipment (fridges, freezers, incubators) are monitored with a 24/7 alarm system, which in turn is monitored by a chain of personnel, such that there is always redundancy.
Key reagents must satisfy predefined criteria to be formally released prior to use.
- The quality management system is based on a feedback system, ensuring continuous improvement.