Assignment Description

On behalf of Region Skåne, we are looking for a consultant to implement, maintain, and support the ATMP Center’s acquired LIMS and eQMS system, QLIMS. The call-off concerns a fixed-price engagement. The role can be carried out remotely, with approximately 1–2 meetings per year in Lund/Malmö, Sweden.

Goal of the Assignment

The goal of the assignment is to configure and implement the ATMP Center’s acquired QLIMS from Simploud so that it supports the daily operations and is compliant with GxP and other applicable regulations. The assignment also includes maintaining the IT system technically and functionally from a life cycle perspective during the contract period of three years. This should be detailed in the quotation sent to Region Skåne.

Project Model and Delivery Approach

Region Skåne believes that the assignment should be carried out as a team delivery. The contractor needs to have documented experience from approved ATMP-adapted implementation of both LIMS and eQMS modules in Simploud’s QLIMS. In addition, experience in continuous technical operation and maintenance of this system is required, preferably over several years.

The contractor should carry out the assignment according to a project-driven implementation methodology, such as a project model. It should preferably be compatible with Region Skåne’s waterfall method.

Before implementation, Region Skåne will conduct an architectural review of the planned design. The contractor is expected to contribute to this process by supplying information about the technical environment, setup, configuration, etc.

Implementation Plan and Timeline

The plan is to first implement the QMS. A module-based deployment shall be applied so that the client ATMP Center can start using the most important modules as soon as they are made available. The full delivery is expected to be in production and fully approved by the client before the end of 2026.

The LIMS implementation is then expected to immediately follow and be operational and fully approved during 2026–2027. Region Skåne expects a module-based deployment for the LIMS as well.

In total, the full implementation is estimated to include 15–20 different modules. The estimation is that each module takes between 40–100 working hours to implement.

High-Level Deliverables

The contractor shall, on a high level, deliver:

• Fully deployed and GMP-validated selected QLIMS modules
• GxP-compliant documentation (both from a validation and technical perspective)
• Assist in validation exercises
• Provide complete, traceable documentation of executed test scripts, ensuring alignment with GMP data integrity principles
• Provide training in deployed QLIMS modules
• Plan for maintaining QLIMS from a life cycle management perspective during the contract

The exact and detailed deliverables and timeline, including module roll-out, will be developed together with the client ATMP Center as soon as possible after the contract takes effect.

Required Skills and Experience

The skills and experience that Region Skåne is looking for from the contractor are:

• Documented GMP experience, especially in computerized system validation (including but not limited to validation planning, URS, change management) according to GxP
• Project management
• Technical configuration in conjunction with excellent documentation skills
• Technical knowledge of ATMP-related hardware and how to connect such devices
• Technical support and maintenance, both during planned downtime and troubleshooting and remedial actions during incidents, preferably of Simploud’s QLIMS
• Domain/best practice knowledge from implementation in the public or health care sector
• Proven experience of life cycle management of equivalent GxP-regulated computerized systems

Particularly appreciated qualities are:

• Excellent communication skills (in English)
• Structure
• Proactivity

Operational Responsibilities and Commercial Terms

As the different modules become operational, the contractor is expected to start maintaining them both technically and functionally. Continuous development of the application will be decided on a “need-to” basis.

Region Skåne would like the contractor to make an offer for implementing, maintaining, and supporting QLIMS at a fixed price. However, further development of the application during the contractual period should be offered at an hourly rate, which should also be included in the offer.

If you have any questions, please contact:

Love Jenninger: love.jenninger@upgraded.se | +46 (0)706 05 36 05

Upgraded People, together with Region Skåne, acts in accordance with and supports the EU’s and Sweden’s sanctions against Russia and the individuals and entities covered by these sanctions. This means that suppliers responding to tenders to provide expertise via Upgraded People to Region Skåne give their own guarantee that they are not subject to these sanctions, and that they subsequently support and comply with them in the same manner.