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
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•
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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
•
•
•
•
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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?
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
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
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
SPC Vision Integration
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 nonconformance.
Business Integration
NC Vision is fully integrated with our data
collections and SPC Software.
NC Vision can be integrated with other
business systems such as SAP ERP.
NC is automatically detected and created by
SPC Vision.
 Links with other business systems
 All product & traceability information flows
from SPC Vision into NC Vision
 No duplication of data input or other tasks
Contact
Infodream Limited
Cardiff Business Technology Centre, Cardiff, CF24 4AY
Tel: 02902 647000 Fax: 02920 647009
email: contact@infodream.co.uk web: www.infodream.co.uk
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