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How to use QM to improve Compliance


The landscape of new and changing regulations for life sciences companies makes it increasingly challenging to maintain the compliance needed to compete in this industry. However, compliance alone is not enough. Quality should be at the forefront, and improved quality management should drive improved compliance.

NNIT provides various services in order to help companies improve their quality management and compliance level:

IT Quality/Compliance
Assess IT organization’s risks and improvement opportunities related to processes (e.g. SDLC, Change Management, Security), SOPs, training, and compliance with regulations.

Assess the QMS (people, process, technology) current level of maturity and identify the risks and areas for improvement. 

Quality Strategy and Roadmaps
Develop roadmaps for mitigating risks, improving processes, and optimizing operations.

QMS Remediation & Implementation
Facilitate the implementation of developed roadmaps to improve QMS and help to remediate the risk areas.

Data Integrity
Assess gaps with the accuracy and consistency of GxP data over its entire life cycle.

Outsourcing Assessment/ Roadmap 
Help companies assess the value, strategy, and key activities required to outsource (virtualize) their QMS capabilities. 
Outsourcing Operations
Transition identified Quality and Compliance activities to NNIT, which will work as part of the client’s Quality organization.

Automated IT Testing
Transition identified IT testing operations to NNIT, which will leverage their automated IT testing operations to test GxP systems (e.g. functional testing, security testing).

Automated Server IQ Testing 
Develop scripts to automate the IQ process for servers and provide services to manage the process for bringing new servers online to support GxP systems.



NNIT here+45 7024 ​ ​​​​​​​​​​​​ here



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