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Quality Management

Optimize compliance measures

Take your compliance set-up to the next level

The NNIT Compliance as a Service

Are you experiencing increasing IT complexity?

IT projects fluctuate – both in calendar time and the resources needed. Therefore, bottleneck issues are common, and it is difficult to maintain a flexible setup with the available resources for both ongoing IT compliance tasks and for developing the business processes and IT services.

Compliance gaps can originate from many different causes. However, the increasing complexity in the IT system landscape and related IT processes has challenged the ability to be in compliance and have a consistent and standardized qualification and validation approach across an organization. It can be equally difficult for pharma companies to keep up with IT best practices and IT related regulatory requirements and legislation.

Due to increasing regulatory demands, computer validation and IT compliance have become more time and resource consuming, and the cost of IT system validation and maintenance has become a significant part of the total IT expenses.

This is why we have developed NNIT Compliance as a Service (CaaS).

What is CaaS (Compliance as a Service)?

CaaS is an off-the-shelf service package that enables you to be compliant at any stage without worrying about resources, skills, upcoming regulations, etc. NNIT’s CaaS services include:

  • Easy access to a flexible and scalable resource pool that is pre-trained in customer procedures (e.g. ITQA/ITQCs, Validation Leads, NC & CAPA process consultants)
  • Cost control via access to on-site and off-shore compliance as well as test and validation consultants
  • Efficient outsourcing of repetitive and time consuming QA/Compliance tasks (e.g. CAPA handling, annual periodic reporting)
  • Staying updated on IT related GxP regulatory requirements, trends, and best practices
  • Access to highly specialized competencies (e.g. Lead auditors for supplier audits).
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What is included in the CaaS package?

The CaaS package will be suited to fit your needs, and could include the following:

  • GxP regulated validation responsibility and track leading
  • Risk management and workshop facilitation
  • ITQC & ITQA Supervision
  • Supplier audits & vendor assessment
  • Periodic reporting
  • QMS/SOP development and maintenance
  • Handling and managing NCs and CAPA
  • Preparation for Inspection Readiness
  • CaaS services are performed by a resource team dedicated to the specific customer
  • Dedicated SPOC is assigned
  • Training Governance
  • KPIs, Quality Goals, and Escalation setup
  • Continuous improvement initiatives
  • Knowledge sharing of practices and trends
  • Cost effective On-site/Off-site set-up
  • Service/Project management
  • Quality Assurance (internally and towards customer) and review processes
  • Communication plan and defined workflows
  • Pricing model and incentives

CaaS is operated using NNIT’s Core Team Model. A core team consists of a team of resources that is dedicated to a specific customer, where NNIT is committed to maintaining customer training requirements not only for the consultants currently engaged at the customer, but also the ‘none-active’ resources dedicated to the customer.

The core team will have the following objectives:

  • Securing fast and easy ramping up and down of the resource pool
  • Taking responsibility for keeping consultants up-to-date with the required customer QMS training
  • Securing that consultants continuously build customer specific knowledge regarding processes, tools, and systems
  • Developing knowledge sharing practices across the team to ensure best practices are developed and shared throughout the team and with customer representatives
  • Securing that senior consultants take responsibility as mentors and advisors for junior consultants
  • Discuss continued improvement of compliance and validation practices within the core team and at customer sites – using this to drive continuous improvement initiatives at the customer, e.g. training on relevant compliance trends, development of processes, tools, templates, or methodologies relevant for the customer.