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How flexible and effective is your QMS?

Quality Management Systems (QMS) today are being stressed by various industry trends:

• Expanded use of third party providers for raw materials, parts, services, etc.
• Increased mergers and acquisitions
• Regulatory directives focused on increased quality awareness and culture
• Focus on data integrity
• Rapidly changing technology

Because of these trends, Quality Management Systems today need to be flexible, adaptable, and scalable in order to keep up with the ever increasing demands.​

NNIT can help assess and improve the 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. This can include technology trend areas, such as cloud computing, mobile devices, and analytics.

Assess the QMS (people, process, technology) current level of maturity and identify the risks and areas of improvement. This involves performing a systematic diagnosis to identify the gaps and/or non-conformances with the relevant regulations, along with identifying areas of improvement across the people, process, and technology spectrum.

Quality Strategy & Road maps
Develop strategy and road maps for mitigating risks, improving processes, and optimizing operations, based upon business and compliance needs for their QMS. A strategy is developed to address prioritized risks and opportunities, a model is designed that fits the organization, and a business case and road map are developed to allow transition.

QMS Remediation & Implementation
Facilitate the implementation of developed road maps to improve the QMS and help to remediate the risk areas. This may include the development and implementation of the people, process, and technology capabilities needed for the new model. Governance structure and metrics are developed to allow a smooth transition.

Data Integrity
Assess gaps with the accuracy and consistency of GxP data over its entire life cycle. Data integrity is critical for ensuring the safety, efficacy, and quality of drugs and medical devices. People, processes, technology, and policies are examined to understand their impact on data integrity.​








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