PLATO - Risk Management for Medical Devices and the Pharmaceutical Industry

PLATO’s software offers overall concepts and solutions to ensure that possible sources of errors are identified and eliminated during development. Universal software support during the early stages of development is indispensable.

Software for systematic risk management

You can already identify relevant risks by using risk management during the production design. These early recognized risks can be evaluated, measured and thus prevented by counter measures.

An effective risk management accompanies a pharmaceutical product during its whole life cycle process and therefore provides an optimal potential to apply modifications to the product or manufacturing process, to communicate the modification and to provide a risk-based decision-making for changes.

PLATO AG offers a long standing experience in developing and applying methods and tools for risk management, change management, document management and project management. For 17 years, PLATO has supported enterprises during the product and process development with solutions ranging from engineering to compliance.

Software for systematic engineering, risk-minimization and process optimization

PLATO SCIO™-med ensures a holistic approach of interlaced data and structures in the production design. The special success of these PLATO solutions derives from a central database, which is shared by all modules. This database enables knowledge management and the reuse of knowledge.

With the application of the PLATO’s risk management software PLATO SCIO™-med, a compliant procedure according to the ISO 14971 and ISO 13485 standard is guaranteed. PLATO SCIO™-med – systematic and methodic risk estimation.

PLATO uses a proven and tested method for risk analysis, with a systematic approach to identify risks. This includes the implementation and the monitoring of optimization measures.

PLATO SCIO™-med - integration into the development and production process

The Requirement analysis automatically supplies input for the risk analysis. This is a great advantage, because the risk analysis provides data for the process planning. The database offers optimal reporting possibilities, also across different projects and products.

Optimized risk management for the fulfilment of the standards for the Medical Device and the Pharmaceutical Industry, like ISO, GMP, FDA

Benefits at a glance:

PLATO SCIO™-med provides optimized risk management for the fulfilment of the standards for the medical device and pharmaceutical industry, like ISO, GMP and FDA. These benefits include:

• Economic success by the development of error free and robust products
• Early identification of possible risks in the design and engineering process
• Consistent data concept from the requirement analysis to production
• Fulfilment of legal requirements
• Robust products of highest quality
• Consistent documentation and archiving

With PLATO SCIO™-med, you fulfil demands of standards and laws for medical devices and the pharmaceutical industry.

• Management systems such as ISO 9000ff, ISO 14000ff industrial safety
• Pharmaceutical inspection convention (PIC)
• Drug Law (AMG)
• ICH-Guideline, Q8 Step4 Pharmaceutical Development, Q9 Step4 Quality Risk Management, Q10 Step4 Pharmaceutical Quality System
• GMP Good Manufacturing Practice: GAMP 5
• VDI 5600 guideline for Manufacturing Execution Systems (MES)
• FDA (21 CFR)

Software comsultancy services

The best software solution is only as good as it’s application by the user. Experienced consultants help to enable you as an enterprise to use our solutions in an optimal way. We assist holistically during the implementation and optimization of your:

• Risk management process
• Change management process
• CAPA management processes

Validation of a GMP-relevant environment

Our software solutions are used within the GMP-relevant environment and validated by GAMP 5. Therefore, we supply standard documents to be adapted to the enterprise-specific application environment. Furthermore, we support the validation process for manufacturing processes and the involved machinery in this environment with our methods and solutions.