Quality assurance department

Novolog is a leading company in quality of service. We are committed to complying with high standards and with the international regulatory requirements pertaining to quality assurance.

We operate a strict and stringent quality assurance system that complies with the quality agreements signed with each distribution partner and reflects the regulatory changes that are taking place in this field.

Novolog’s quality assurance department is responsible for the following:

• drafting protocols to validate all quality assurance processes. For example: load testing on refrigerated vehicles under a variety of loads and environmental conditions; testing infrastructures and computerized systems, etc.;
• managing the calibrations of all measuring equipment;
• the organizational training system, focusing on work procedures, professional training, quality, safety and security training;
• customizing control processes to the needs and requirements of our various partners;
• managing anomalous incidents – investigations, containing the incident, actions to resolve the incident, sharing the investigation reports through the relevant channels and preventing recurrence of the malfunction;
• risk management in relation to every new process that Novolog initiates and for any anomalous incident that occurs;
• the quality management system that manages all quality systems in use, including documentation of all incidents that occurred and how they were handled. The system produces reports to promote learning, and includes a full audit trail for the quality assurance department’s records.

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We carry out an annual internal audit program for the purpose of quality assurance during sensitive work processes at Novolog. Our quality assurance department performs audits in the organization’s various departments and among suppliers that provide service to Novolog.

Additionally, the Israeli Ministry of Health conducts regulatory audits at Novolog, and our distribution partners conduct dozens of inspections during the year in order to verify compliance with the quality requirements and standards.

Our advanced quality assurance system enables Novolog to maintain the following Israeli and international standards:

GDP – Good Distribution Practices for medicinal products

GMP – Good Manufacturing Practices for localization processes we perform

Israeli Ministry of Health Procedure 130 – which includes all of the GDP requirements

Pharmaceutical companies’ stringent Key Performance Indicators (KPIs)

ISO 9001:2015 – Quality Management Systems

ISO 13485:2016 – Quality Management Systems for Medical Devices 

ISO 27001:2013 – Information Security Management Systems.

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