Developing high-quality MBRs for you
“Our ‘Design as a Service’ offering allows us to provide our customers with much more than the mass conversion of paper-based recipes into digital copies which is usually referred to as MBR factory.”
Lars Söding, Head of Consulting & Training, Werum IT Solutions
"Design as a Service" - more than MBR Factory
With “Design as a Service” we offer a complete solution for the cost-effective creation of lean, high-quality and streamlined MBRs. The package comprises pre-configured PAS-X Content Packages with industry-specific content based on best practices, ready-to-use concepts and guidelines for the efficient creation and optimization of MBRs and profound, first-hand PAS-X knowledge.
Our services comprise:
- Design, creation and verification of MBR templates with certified quality
- Large-scale production of final MBRs - also known as "MBR Factory"
- Creation of global harmonization concepts and global MBR templates
- MBR optimization
Our MBR development methodology includes the design, creation and verification of MBR templates.
Our approach comprises three steps:
- MBR Design
Together with you, we develop and document general design rules on site including a data and design concept as well as acceptance criteria for the verification process.
- MBR Creation
MBR templates covering the entire process on a detailed level are created off site based on the data and design rules.
- MBR Verification
The MBR templates are verified based on criteria defined in the design phase.
In a continuous review process, the resulting MBRs are matched with your business processes in every step to ensure high-quality and efficient MBR creation. This approach also offers you the opportunity to revise and to redesign and optimize your business processes.
We will certify the quality of your final MBRs by checking them against the MBR design specification created in the MBR design phase.
- High-quality and efficient MBR design
- Accelerated MBR development at reduced cost
- Standardized design rules for all MBRs
- Best practice industry design
- Verified MBRs based on design specifications
Large-scale MBR production
We offer to create and verify your final MBRs based on MBR templates on a large scale. This service, also known in the industry as “MBR Factory”, will be based on the corresponding guidelines created during the MBR design phase. The MBR creation itself can be done off-site and is therefore very cost-efficient.
- Accelerated creation of final MBRs
- MBR creation based on high-quality and efficient MBR design
- Cost reduction due to minimized training efforts and onsite activities
Content packages to accelerate MBR creation
The creation of MBRs can be accelerated considerably by using the “PAS-X Process Libraries” and “PAS-X Equipment Libraries” Content Packages.
- Significant time saving in MBR creation (up to 80%)
- Standardization of production processes
- Cross-referencing / tracking capabilities
- Migration capable
- GMP compliance based on the best practices of the pharmaceutical and biotech industries and reflection of the requirements put forth by the PAS-X user community
- Supporting process harmonization across sites
- Lean MBR design
Global MBR templates and libraries
In the context of “Design as a Service” we provide dedicated services for the creation of global MBR templates and Process Libraries based on our MBR development approach to accelerate global MES deployment projects. We offer to create or support you in creating strategies and concepts for the global harmonization of your recipes. This will allow you to establish high-quality standards on a global level following best practices.
Here, our specific services comprise:
- Development of MBR concepts and guidelines
- Global MBR design concepts
- Global MBR lifecycle guidelines
- Global MBR development guideline
- Global MBR review guideline
- Global MBR verification guideline
- MBR change control guideline
- Localization guideline
- Development of global MBR design elements (MDEs) for each process incl. traceability matrix
- Development of global generic MBR templates incl. technical testing