QMS – Quality Management

The QMS, or Quality Management System is used to keep records and manage the quality processes in a control laboratory or the entire organization. An integral part of the QMS system is a documentation management and training described under DMS and LMS.

Main QMS functionalities and modules

  • Deviation management
  • Change control management
  • Audits and observations
  • CAPA management
  • Out-of-Specifications (OOS)
  • Complaints
  • Risk management

Deviation or non-conforming work management

The Deviation management, or non-conforming work module allows you to record a deviation from a procedure, method, process, specification, or other system; and to evaluate and record as to whether it is significant or not. The system will help investigate and record the root cause of the deviation and ensure through corrective and preventive actions so that the deviation does not occur again. In addition to improving quality, this also has an impact on the costs. The greatest benefit of successful deviation management is that the same deviations will not occur again and will not require resources to investigate and address the impact.

F4 Approval
Approvers, Approval date
F5 Closure
F1 Deviation logging
Deviation identification number is assigned automatically. Basic data entry: Issue description, Date of detection, Initiator, Inform customer, etc.
F2 Enter data
Deviation coordinator, Root cause, Responsible person, Customer response, etc.
F3 Review data
Classification, CAPA plan

Other modules

Change control 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 (Preventive and Corrective Actions)

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).

Out-of-Specification investigations (OOS)

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.).

Complaint management

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 and observations

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.

Vendor qualification

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

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.

Configurable workflows and roles

Configurable workflows and roles

Any workflow or process usually starts with a registration of the event or a case, and includes event description, review, approval, execution of related CAPA actions, event closure and archiving. To strengthen and simplify the workflow management, graphical features can be used to monitor deadlines, e.g. the traffic light system, or email notifications and message center, including automated reminders and escalation models.

Audit trail and History

The system maintains an audit trail and history of records. It also supports audit trail review by means of filters and allows users to sign off on the record history. All records, workflow, workflow phase changes and user activities are 100% traceable and cannot be tampered with or deleted.

Undesired records can be moved into a bin, with a full history and rationale, from where they can be restored or their history can be viewed.

General functionalities

In all modules, users can use general functions like filters, full-text search, exports, and imports, attachments (PDF, docx, xlsx, jpg, png, etc.), links to related records and managerial reporting using configurable reports or MS SQL queries.

QMS and DMS/LIMS connection

The QMS modules can be linked to each other or to DMS and LIMS, all in one single validated environment. The connection and maintenance of all records from one single system speeds up the laboratory operation and the approval processes, eliminates the need for user login to multiple applications and meets the data integrity requirements.

Examples EffiChem 5.0 QMS


Deviations module

The Deviation module helps to register, approve, process and manage deviations. The typical data registered include the deviation name, description, classification, detection date, initiator, coordinator, responsible person, the root cause, the related CAPA actions, conclusions and approvals.


Deviation detail

The deviation record shows the automatically assigned identification number and descriptive data such as the deviation name, detection date, initiator, coordinator, the deviation description, deviation classification, responsible person, root cause, CAPA actions, customer notification details, conclusions and approvals.


Change control module

The Change control module is a tool to registered, approve and process the quality and compliance related changes. The registered descriptive data include the name, change description, category, reason for the change, initiator, coordinator, responsible person, etc. The next step is the impact assessment of the change – impact on documentation, personnel, methods, validations, calibrations, etc., followed by the change approval, implementation of related Actions, change closure and the effectives check.


Change control detail

The change control detail typically shows the automatically assigned identification number, the change name, quality system, category, classification, initiation date, initiator, coordinator, responsible person, closing due date, description and reason for change. This is followed by the impact assessment – impact on documentation, personnel, methods, validations, calibrations, etc., followed by the change approval, implementation of related Actions, change closure and the effectives check.



The desktop is a cross-road from which individual functional modules can be started, including Samples and Results, Controlled documents, Equipment, Reference Materials, Deviations, Changes, CAPA, Statistical data evaluation, etc. The desktop can be individually configured per user for maximum efficiency.