QMS – Quality Management

Change management is one of the basic requirements of a Quality Management System in the pharmaceutical industry. It enables evaluation and recording whether or not a proposed change has an impact on the marketing authorization of a medicinal product and the ability to manage actions to ensure that the implementation of the change does not disrupt the terms of the marketing authorization. Change management includes changes in equipment, processes, materials, specifications, methods, documentation, computer systems, suppliers, labelling, and packaging, EHS changes, and validation changes.

CAPA management allows users to address and respond to adverse events, complaints, audit observations and deviations. CAPA management ensures the process of implementing actions and monitors their effectiveness over time. The timely implementation and closure of CAPAs is typically monitored via company’s key performance indicators (KPIs).

OOS follows up on the management of Samples and Results, in case the test result reported by the first analyst is outside the limit prescribed by the specification. An investigation process is then initiated to determine if the root cause of the Out-of-Specification result is assignable (instrument error, analyst error, etc.) or non-assignable. Depending on this, the testing is either repeated by the first analyst, or a 2nd or 3rd analyst are involved, or the sample is re-sampled and a re-test plan is approved and implemented. All this can be recorded in the system and linked to the other related records (Samples, Deviations, CAPA, etc.).

Complaints handling is an element of the Quality System in both the pharmaceutical industry, and ISO 17025 accredited laboratories. The aim is to retain customers, comply with regulations and avoid potential disputes over product quality or service. The customer complaint management system enables users to record, investigate, and respond to complaints. In addition, it is also suitable to track trends in complaints, enabling the management reporting and follow-up on the implementation of the CAPA actions.

Audits by government bodies, regulatory authorities, customers, or in-house, examine critical processes identify gaps and help laboratories and companies to improve quality. The Audit management module enables efficient recording of audits, observations and the management and implementation of the appropriate corrective and preventive actions (CAPAs) to ensure proper resolution and communication of remediation to the auditor.

The Vendor approval system was designed to ensure that suppliers of materials and services selected by the company, are reliable, have adequate quality, and that they deliver on time, and accurately according to the specifications and purchase orders. The Vendor qualification module allows standardization of the supplier approval process according to defined criteria, related to the type and criticality of the deliveries. The module offers effective reporting, based on the supplier group, type of approval, etc., and enables tracking the deviations in deliveries or the resolution of CAPA actions. This extends the company’s Quality System towards its supply chain partners.

Risk management is a systematic approach to the analysis, evaluation, mitigation, and re-evaluation of risks, particularly required in the pharmaceutical and medical device industry and ISO 17025 accredited laboratories. The risk management module enables the integration of risk management processes with other quality management processes – deviations, changes, complaints and audit observations – to facilitate the implementation and maintenance of a risk management program in accordance with ICH Q9 and ISO 14971.