Life Science Approach

NEAR supports its clients in all of their Quality Management System activities
that are related to GxP:

 

Implementation

Our life science engineers receive GxP trainings from our internal training center. Best practice and community of prcatices allow NEAR to offer a state-of-the-art approach to the implementation of quality topics from QMS to CSV, working fast, structured and in compliance.

 


 

Supplier Audits

the choice of the right supplier is deteminant for the project success. Life Science suppliers need to have a thourough assessment in the initial phase of a project study. NEAR enables the best choice with the most advanced AUDIT techniques and tools.

 


 

Management

As well as implementation engineers NEAR offer a level of management specialists able to deal with complex systems and topics as well as with teams either on a project basis and on an interim solution.

 


What about Suppliers?

NEAR has a unique approach to evaluate the potential enhancement for Suppliers and Vendors that are faceing the Life Science industriy both for the first time and as a seasoned and consolidated business supplier. Ask our representatives for more information.

 


 

Internal Audits

Auditing is the greater part of compliance. Either in internal AUDITS and supporting the regulatory AUDITS, NEAR is the partner that will gain trust and reliability for your Quality compliance.

 


 

GxP and QMS

Regulatory bodies and authorities mandate that a quality system based on SOPs enables to maintain control, monitor and compliance with regulations as well as protecting your data. NEAR can collaborate with the preparation of SOPs covering all IT processes and procedures both with a standard approach or a customized set of documents tailored for the specific system.

 


Quality Management

An existing Quality Management System can be supported by NEAR in terms of:

 

Development

A quality management system needs to ensure Document Control at every stage of the product, process and service lifecycle. The development of the appropriate strategy can rely on the NEAR's experienced resources. We can recommend the strategy as well as manage your implementation projects on a on-site, near-shore and outsourced models

 


 

Gap Analysis and Optimization

Our capabilities and expertise span from Audit Management to Corrective Action evaluating your strategies for Non-Conformances, Risk Management (ex. FMEA), Change Management, Calibration and Maintenance, Backup & Restore, Disaster Recovery, Business Continuity Plan, Project Control, Employee Training and Supplier Management

 


 

Computerized System Validation (CSV)

Our expert can assist your Quality Assurance in the creation of a CSV strategy or analysing the gaps in your existent QA CSV or providing resources for temporary exceptional or standard CSV tasks (on-site, near-shore and outsourced)

 


 

QMS Validation Packages

 NEAR provides a highly skilled execution team, the best practices, and trusted methodologies to guarantee it's clients a rapid and cost-effective approach to implementing, configuring, validating and integrating their QMS

 


 

Enterprise Quality Management

NEAR supports the main Enterprise Quality Management applications

 


 

System Qualification

Together with the CSV services, NEAR's experts can provide best practices for embedded softwares and equipment/medical devices qualification (FAT, SAT)

 


 

Quality Systems Inspection Techniques

FDA's QSIT model that emphasizes the critical importance of a QMS will be taken by NEAR as a framework to get a holistic view on client's QMS

 


Manufacturing System Support

NEAR provides Planning, Compliance and Validation Execution for Manufacturing Systems:

 

Design of products

 Our engineers are able to provide expertise spanning from product design to prototyping and designing the compliance testing requested by the GxP processes


 

Manufacturing Project Management

 We have the necessary resources to ensure high level standards of PM following the modern frameworks (ex. PMI, AGILE etc.) to achieve the best balance between cost and validation efforts as well as adding value to your production chain

 


 

Storage and Distribution Analysis

Our experts are trained on the most actual regulation for distribution of Pharmaceutical and Medical Devices and can analyse the gaps that may cause actions after AUDITs. This is purely a preventive action that can save a lot of money that could be invested in other projects

 


Design of Processes

 Study of processes for your production that match the actual regulations and standards finding the innovative way to achieve your expectations, ROI, cost reduction and continuous improvement

 


 

Labelling & Packaging

According to FDA regulations as well as other regions' regulations medical devices, drugs and nutrition products must be labelled and require specific guidance. NEAR is providing the resources to evaluate gaps, identify corrections as well as helping the customer to manage their projects on-site, near-shore and outsourcing.

 


 

Supplier Audits

Supplier management is growing importance proportionally with evolution of technology. To protect your brands and your reputation you need to ensure that your supply chain's partners consistently comply with your high standards of safety, quality, and security to actively support your values. NEAR is offering customized Audits on your behalf as well as acting actively with your processes and procedures. We are caring for the periodical Auditing and the supplier supply chain relationship.

 


 

Compliance Services

Compliance means also competitiveness. The more compliant a Life Science company is the more competitive. This is translating to competitive advantage and market value increase. Our consultants are trained to analyse the company compliance and resiliently work with our customer to optimize, enhance and exploit the best compliance's solutions