If you work with Quality Management and Quality Assurance in life sciences, you are probably all too aware of the fact that managing peak loads is not for the faint hearted.

Even the most talented managers can find it a balancing act to ensure that highly skilled resources are available when and where needed. And when resource bottlenecks occur, they have to be managed quickly and efficiently without losing focus on the overall goal of QM and QA processes that meet regulatory requirements and live up to best practice.

At NNIT we have worked in this field for many years and understand the specific challenges it presents to QA managers. That is why we have designed a range of modular management services to address specific processes in two main areas: QMS governance, and QA and validation support for IT projects and operations. Our specialist teams are always up to date with best practice and current regulatory requirements and provide services tailored to support your compliance efforts within your QMS framework.

In short, we ensure the quality you need when it is most needed.



QMS GOVERNANCE
Audit, assessment and inspection preparation
Planning and execution of audits with focus on compliance with standards and regulatory requirements as well as QMS efficiency.

Management advisory and reporting services
Planning and preparation of management reports detailing the compliance status with respect to audit result, non-conformities, complaint handling, quality improvement and compliance status of projects, IT systems and platforms.

QMS Maintenance
Continuous QMS updating and improvement, including managing process improvement activities, advice on new and current regulatory requirements, updating QMS SOPs, planning and training in QMS and validation activities.

QA PROJECT SERVICES
Vendor selection & management
Evaluation and selection of vendors according to compliance capabilities. Quality assurance for managing vendor deliverables.

Validation consultancy
Full responsibility for all validation activities during development, operation and maintenance, including management and execution of the necessary validation activities in close liaison with the project team and relevant QA stakeholders.

Test management
Management and execution of test activities using HP Quality Center© Evaluation and optimisation of test procedures with relevant employee training. HP Quality Center© can also be provided individually as an ASP or SLA based solution.