Consulting Services

You can substantially improve your productivity and utilisation and reach an optimal level of efficiency by working with the flow of material, products and information through your facility. We help you optimize the flow.

What manufacturers need today is a more efficient handling of products and utilization of assets with Compliance maintained. At the same time, the requirements from FDA as well as other authorities are increasing, in particular regarding automated lines and the handling of electronic production data. Optimizing your manufacturing processes and shortening your lead-times is our mission. Our focus spans incoming to outgoing goods, from simple to highly automated lines, always with GMP regulations compliance at heart. Most important, we work in partnership with our customers in pursuit of efficiency and cost-effectiveness.

Methodology

Our quality management system follows ISO9001 and the GAMP guideline. Together with our project model this ensures a controlled and efficient project execution.

S-PROPS Pharma Fast Track^TM is a well used project model developed in response to the ever-growing demand for reduced cost and time needed for projects and validation activities.

Projects cover three main phases:

1. Conceptual study

• CL Clearview VSA™
• Value Stream Analysis
• GMP Impact Assessment
• Risk assessment
• Production Logistics Efficiency

2. Design & Engineering

• Basic design
• Detailed design
• Pre-Qualification
• FAT (Factory Acceptance Test) & Commissioning

3. Implementation & Verification

• Installation
• SAT (Site Acceptance Test)
• Qualification, IQ, OQ (Installation and Operation Qualification

Consulting Services

• CL Clearview VSA^TM
• GMP in-house seminars and training
• Production plans and layouts
• Investment analysis
• Lean Manufacturing
• Value Stream Analysis
• GAP Analysis of GMP compliance, e.g. for part 11 compliance
• Optimization and scale-up
• Risk assessment
• Project management
• Engineering, design and programming
• Implementation and installation
• Lean Validation^TM
• Maintenance and support of delivered solutions.

CL Clearview VSA^TM

CL Clearview VSA ™ is a conceptual study of the flow of products and information at your facility, done with the aim of achieving production efficiency - a quick and inexpensive way to initiate an increase in productivity and cut costs, while maintaining In Compliance.

The main functions

We start the process by mapping out the current state of your production. We look for the answers to the following questions:

• What waste can be eliminated to make the process more lean and efficient?
• How can the production logistics process be improved?
• Where should we start to achieve the greatest efficiency?
• How will this impact the current validation and what will the cost and effort be to revalidate?

We define the impact a move to production efficiency will have on your validated status and what the scope in terms of effort and cost of revalidation will be. 

The differences that make the difference

At Compliant Logistics we use our unique tools, the Value Stream Analysis combined with GMP Impact Assessment, to provide a useful and pragmatic analysis.

The Value Stream Analysis maps the material and the information flow in the production chain, covering indoor logistics dock to dock, and in some instances including customers and suppliers. Basically, we follow the production cycle of certain selected products and map them completely from start to finish.

The resulting Current State Map shows productivity, bottlenecks, availability, throughput time and first-time yield. Waste is discovered and becomes the starting point for improvement decisions. Based upon the current state map, measurable KPI’s are defined and the effectiveness of the changes traced.

The GMP Impact Assessment covers the aspects of meeting GMP requirements, and ensures all changes in your production activity will meet qualification and validation criteria and remain in compliant.

Download CL Clearview VSA^TM, PDF Document, 118 kB

Lean Validation^TM

We have developed the concept Lean Validation^TM. Lean Validation^TM is a methodology developed to ensure cost-effective validation based on impact and risk classification, tracing of requirements, modular approach and parallel activities.

Lean Validation^TM saves money and time to market and ensures that you focus your efforts where they are most needed for risk elimination, maintained quality and manufacturing in compliance with regulations.

Download Lean Validation^TM Service Description, PDF Document, 118 kB