Compliant Logistics - Medical and Pharmaceutical Production in Compliance with GMP Regulations

We know and understand the medical device and pharmaceutical industries' requirements. By providing integrated products, solutions and services for the production logistics and optimisation of plant operation, we support our clients' ambitions to achieve lean manufacturing whilst keeping a cost-effective level of in compliance. We optimise manufacturing by managing the flow.

We provide you with the latest technologies within lean and GMP-compliant manufacturing and information handling. At Compliant Logistics we integrate technology and services and use knowledge transfer from other industries, such as the telecommunications and automotive markets, to give you a competitive edge.

CL PHARMASUITE™ PHARMACEUTICAL PRODUCTION SOFTWARE

CL Pharmasuite controls and manages the production flow and provides traceability for everything that occurs on the line. The software manages complete production lines and its processes such as preparation, assembly, inspection, testing, repairing and packaging.

CL Pharmasuite works in real-time, on the factory floor. This closeness to production and its real-time ability gives you effective production control and secures safe implementation with a minimum of validation effort. The ease of validation is further strengthened by the ability to securely link to ERP and other systems. As an option in CL Pharmasuite, CL Electronic Batch Records™ (EBR) creates a paperless production system.

CL ELECTRONIC BATCH RECORDS FLEXIBLE PAPERLESS PRODUCTION

Compliant Logistics’ EBR software replaces today’s paper-based batch documentation with a fully electronic paperless system. This approach allows you to easily adapt to lean production and flexible batch sizes without the burden of creating huge amounts of paper-based documentation. The software is designed to fulfil applicable GMP requirements such as FDA CFR 21 part 210, 211, 820 (QSR), 11 (ER/ES) and European directives 93/42/EEC (MDD), developed according to GAMP guidelines. Each customer application is qualified (IQ/OQ).

MATERIAL, PRODUCTS AND INFORMATION FLOW OPTIMISATION

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, whether greenfield or re-built. We help you optimise the flow.

Our consulting services include:

• CL Clearview VSA™ – conceptual study
• 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
• Optimisation and scale-up
• Risk assessment
• Project management
• Engineering, design and programming
• Implementation and installation
• Lean Validation™
• Maintenance and support of delivered solutions

CL CLEARVIEW VSA™ – PRODUCT AND INFORMATION FLOW CONCEPTUAL STUDY

CL Clearview VSA is a conceptual study of the flow of products and information at your facility, 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.

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

LEAN VALIDATION™

We have developed the concept Lean Validation. Lean Validation 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 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.

CL AUTOMATED SOLUTIONS – INDIVIDUAL UNITS TO ENTIRE ASSEMBLY LINES

Compliant Logistics provides automated solutions, offering our clients a range of products and services from individual units to entire assembly lines. We approach your need from the process and production-flow point of view. By identifying areas for improvement and gaps in the production flow, we provide integrated solutions that enable you to reach maximum productivity and cost efficiency while remaining in compliance.