Risk Management System

Organised quality assurance activities contribute with a good risk management strategy to a tangible improvement in patient and consumer’s care and safety. Interfacing proactive risk management programs and a quality assurance programs provide a dynamic approach beneficial for both Risk Control and Quality enhancement.

We value the following framework and our experts can guide your organisation through the analysis and application of, for example, ISO14971 and any related Risk Management need for specific cases. This is not limited to Life Sciences only but is extending to any other industry requiring an exhaustive and complete Risk Management approach.


Risk Assessment

In a nutshell, Risk Assessment is defined as the systematic process of organising information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

Risk assessment is one of the tools that NEAR’s Consultants master to initiate the analysis of involved Risks from requirements to project completion. According to the FDA Guidance for Industry Q9 Quality Risk Management a typical process should look like the following:


Decision making to reduce and/or accept risks represent Risk Control. We help our customers to maximize the risk control through the knowledge of the application of the industry best practices with the scope to reduce the risk to an acceptable level. We always try to balance the amount of effort used for risk control according to the significance of the risk. The ultimate goal is to help the decision makers to have a customized tool set among their quality processes, as well as benefit-cost analysis to achieve the optimal level of risk control.

NEAR Consultants are able to create a Quality Risk Management Process tailored to your requirements aiming to have a secure Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.

This approach will teach that this Quality Process should be applied systematically and become an ongoing repeatable task.

NEAR supports its clients to succeed this challenge.


Audits and Compliance Analyses

Analysing the huge amount of regulations, guidelines and standards in the IT Environment and clarifying the needs for ones’ company requires experienced, non-committed and independent experts. NEAR supports its clients with this expertise. These include monitoring compliance with company policy and government regulation, detecting and preventing fraud up to the opportunity to test internal controls.

NEAR’s experts use AUDIT best practices and experience to define the following AUDIT tools:

Gap assessments – analyse specifically a policy or process against regulations and standards

Monitoring of Internal Controls – Examination of policies and procedures on a regular basis to minimise the exposure to inconsistent processes and procedures

Operational AUDITS - Operational audits examine the practices of a company and the effective results of the application of policies and processes

Internal AUDITS – aims to improve the processes and controls, and analyse the robustness of their application

NEAR’s auditors are experienced professionals aiming to support the clients in their AUDIT needs and offer support to the internal auditors of the company as well as taking full responsibility for the AUDIT team management.
The aim of NEAR’s service is to accompany the customer’s organisation to achieve full regulatory compliance


Computerized Systems Validation (CSV)

Validation, in general, is a good practice and for certain aspects mandatory task to complete in order to cover all the Quality regulatory requirements requested by the FDA, the EC and the WHO. This Validation action represents the assurance that the regulatory controlled products are manufactured according to the intended use.
NEAR is offering a unique expertise based on cGMP (current Good Manufacturing Practices) to help its customers to achieve the intended use of all requirements.
Documentation is the means to comply with the regulations and standards and the evidence that your regulatory controlled products meet the intended use of their requirements.

We define three categories of documents’ organisation and management:

Paper Based - Documentation is on paper, all reviews, approvals, and signatures are manually executed
Risks: time to completion very long and costly                            Value: only the validated state

Paperless (Electronically Managed) - Documentation is managed electronically all reviews, approvals, and signatures are electronically executed
Risks: resources’ acceptance and train may have constraints                  Value: cost-effective, time and resources saving, easy to manage and very controlled

Mixed - Documentation is on paper, all reviews, approvals, and signatures are electronically executed or some of these actions are partially manual
Risks: Loss of data, potentially process confusion, and very expensive                                 Value: only the validated state

We help our customers to navigate through the best solutions in terms of systems, documentation strategies, and documentation processes.
Our gap analysis techniques help us to recommend and predict the best solutions to defend a potential AUDIT or Investigation


Our Approach

Guidance: GAMP5 - We base our approach on the GAMP5 categories and design the best approach according to the specific requirements of our customers

Standards: ISO 13485:2016 - Our consultants are able to analyse the customer QMS current compliance to the standard as well as implementing it. By the year 2019 the ISO 13485:2016 has been enforced; this means that all Medical Device companies must adequate ISO 13485:2003 to the new revision.

NEAR’s consultants can help Medical Device manufacturers to adequate their quality management systems.

Regulations: 21CFR820 Quality System Regulation - We are expert in analysing the needs of the quality systems regulatory requirements of the various countries where the medical product is offered in the market.

Our consultants are able to help the Medical Device manufacturers to find the tailored solutions that comply with any market or/and with regulatory requirements. This will be optimised to avoid over-compliance and find the right balance between Standard Conformity And Regulatory Compliance.