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Managed Validation Service

Managed Validation Service

Increasing regulatory requirements, slower market growth, and digitization are putting manufacturers in the life science industry under increasing cost and efficiency pressure. All resources are required to work on the issues that drive the business forward and keep it competitive. Research, development, efficient production, …

Often, this is at the expense of computer system validation, which is not being focused on and no longer gets the required attention. Neglect would, however, be fatal, as failure to pass audits will of course have negative consequences for the company’s performance as well.

If you are focused on your core business and do not want to waste your time on upcoming audits, we can offer you a good solution:

Managed Validation Service

With this model, you get complete computer system validation from a single source, embedded in your organization. This means that HGP will handle all the work involved in this area together with a team of pharma-experienced CSV specialists.

As a project manager, we are responsible for the planning and implementation, quality assurance, compliance with time and budget requirements, as well as project and resource allocation.

The HGP Service Manager is available as a contact for your project teams and your compliance organization and reports on performance and project status as well as KPIs.

Your added value with the Managed Validation Service model:

Cost savings

  • Services from different providers are complex in terms of coordination. Redundant processes and fluctuating quality incur additional costs that can be avoided. If all consultants work as one team and are managed by a designated service manager, the processes remain lean, clear and subject to a consistent quality standard.

Time savings

  • Time is also reduced if the service comes from a single source. The management of service providers from different companies is completely eliminated. A well-coordinated team delivers the agreed deliverables.
  • No more stress from audits, no time-consuming rework: We guarantee “First Time Right.”
  • No more juggling with resources: Should unforeseen services be required, HGP can provide the right specialist immediately.

Quality & transparency

  • Guarantee on deliverables in invariably consistent quality verified by HGP.
  • The HGP Service Manager is available to you as the point of contact regarding project status, adherence to KPIs, etc., just like a responsible employee of your own organization.
  • Clear cost model: You will receive a specific range of services for your project portfolio in which schedules, costs, and services are defined as binding.

Why HGP?

  • Smooth resource supply through our own recruiting organization
  • Many years of experience with the Managed Validation Service model. HGP has successfully defined, established, and operated service models for IT compliance for various customers.
  • HGP consultants understand the business not just the compliance requirements.
  • HGP consultants are more than validation experts. Each consultant has specific additional knowledge of current technologies and industry trends such as data integrity, privacy, cloud computing, Pharma 4.0, and more.
  • HGP is globally positioned and serves various clients in Europe and Asia. References are available!

To find out how such a Managed Validation Service could work specifically for you, please contact us.  We will provide you with a proposal on how we can specifically support you based on some information about current projects, existing consulting models, and corporate goals.