Statistical Process Control for the Medical Industry

SPC – Your Quality Portal SPC Vision - Meeting the needs of compliance & Innovation PAT (Process Analytical Technology) is innovative framework which provides an alternative way to be consistent with regulatory requirements such as FDA’s CFR 21 parts 11, 210, 211, 820, 93/42/EEC and ISO 13485:2003 whilst promoting innovation and continuous improvement. SPC Vision is Infodreams data collection and process control software which allows you to meet many of the PAT requirements. Key Benefits Increased Productivity & Efficiency Real Time Quality Assurance and Process Control Product & Process Validation Increased Process Understanding Electronic Data retention and traceability

SPC – Your Quality Portal SPC Vision - Meeting the needs of compliance & Innovation Infodream has a strong history of working with the pharmaceutical and medical industries with many leading companies such as GE and Trixell being part of our ever expanding client list. SPC Vision is Infodreams software application that allows your company to meet the regulatory requirements of regulatory bodies such as the FDA and PAT, whilst simultaneously giving your company the opportunity to increase productivity and profits. Key Benefits of SPC Vision Increased Productivity & Efficiency Real Time Quality Assurance and Process Control Product & Process Validation Increased Process Understanding Electronic Data retention and traceability

SPC Vision – Are you in control? Automatic Data Input Speed up measurement time, eliminate manual recording errors, and remove unnecessary paperwork from the shop floor.  SPC Vision can import data from almost any measurement device Traceability & ERP Integration Measurement traceability is an extremely important requirement for all of our customers and is a very strong feature of our software. It has FDA 21 CFR Part 11 Pharmaceutical accreditation. To further enhance the traceability SPC Vision can be linked directly to your ERP system Innovation and Efficiency PAT (Process Analytical Technology) encourages the development and implementation of innovative medical development, manufacturing, and quality assurance. SPC Vision means: Reduction in production and cycle times At line and In line measurements and controls Resulting in quality and efficiency of end product

SPC Vision – Your Quality Portal User Friendly We understand that introducing SPC is never easy – the last thing that any company needs is complex and cumbersome software.  All elements of SPC Vision are simple to use  Clear, concise information Increase Efficiency of Processes SPC Vision measures and analyzes the overall efficiency of the manufacture and assembly process. This information is reported very clearly so that bottlenecks and non value adding steps can be improved or removed altogether.  Overall process time  Time taken at each step of the process  Identifies bottlenecks Global Reporting SPC Vision has various reporting options to satisfy the needs of many end-users.  Ranges from elementary part trends to global capability analysis  Full report feature which is individually customisable

NC Vision – Your Quality Portal Each time a non-conformance is logged and processed, NC Vision builds up a detailed historical picture of problems and action implemented. This allows ‘Rules’ to be defined and applied under similar conditions which drastically reduces the time to process the non- conformance. Business Integration NC Vision can be integrated with other business systems such as SAP ERP.  Links with other business systems  No duplication of data input or other tasks SPC Vision Integration NC Vision is fully integrated with our data collections and SPC Software.  NC is automatically detected and created by SPC Vision.  All product & traceability information flows from SPC Vision into NC Vision

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