TTM100 00 Manufacturing Line Serial Number Management System as - PowerPoint PPT Presentation

TTM100 00 Manufacturing Line Serial Number Management System as used in EU BRIDGE WP6 Pilot Project and Irish Blood Derivative Trials m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Introdu oduction ction TTM100 is: • A simple to use serial number management system – for production/manufacturing line use. Interfaces with a variety of coding devices – (which can be readily expanded) Able to work with numerous vision systems and code readers – (Cognex and Pepperl Fuchs used during BRIDGE ) Able to communicate, – in two directions, with higher level hosts (such as Navision, SAP, Oracle Enterprise etc) m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Descr crip iptio ion TTM100: • Has web-based user interface or it... – Has a ‘forms’ based user interface. – Is readily adapted to work with touch screen industrial PC equipment. • Uses components that have already been used in live manufacturing situations • (and continues to be today) Uses easily adopted and adapted • XML interfaces for inter-system integration. m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Technolo nology gy TTM 100:  Uses Microsoft Windows TM Technologies  Is designed and built by a Microsoft Certified Partner organisation.  Uses .Net and makes extensive use of XML to ease interoperability  Is highly modular and easily adapted to specific requirements  Makes extensive use of proven code modules for reliability  Works with many existing customer owned systems  m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Why TTM100 0 ? Used successfully during the BRIDGE pilot • Capable of flexible adaptation for • specific customer requirements Uses a simple modular design to ease • testing and validation Able to work with numerous • Database standards (e.g. MS SQL Server, Oracle etc) TTM100 is able to apply serialised codes • only or, as was undertaken during BRIDGE , aggregation to over ten levels m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Archit itec ectu ture re TTM100 assumes that Enterprise level control will be assumed • by an existing enterprise suite (e.g. SAP, Oracle etc) TTM100 is a client server architecture designed • for production facility integration. TTM100 is architected to ensure that each • production line is autonomous and thus any individual system failure will remain isolated to a single failure instance (i.e. Not take down the entire manufacturing operation) m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Coding ng Technology ology TTM100 is able to work with both:  Printed code data carriers such as DataMatrix,  Linear, PDF417 etc … and RFID either GEN2 or HF.  TTM100 was designed to be data carrier agnostic  – the only limitations placed on the system will be the capability of the carrier. m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Data Managem emen ent Able to combine the elements of: • GTIN/Product Code (NDC etc) – Serial Number – Expiry Date – Batch Code – In a user define construct to suit the – coding application being undertaken e.g. BRIDGE, EFPIA etc Retains all data constructed and • used to allow easy reconciliation. m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Data Managem emen ent TTM100 is able to produce reports for: • Individual items – Container items (e.g. cases, pallets etc) and contents – System users – auditing actions – TTM100 can serialise using sequential numbers or random numbers. • TTM100 is able to adopt customer own randomisation algorithms either • directly within the system or via compatible dll (dynamic link library) m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

TTM205 05 Mobile Phone based  code scanning m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s 10 e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e

Contact Details: Tony Walsh, Mentor Pharmaceutical Consulting, 53 Welland Place, Ely, Cambridgeshire CB6 2XA UK Tel: +44(0) 1353 669218 Mobile: +44 (0) 7717156683 e-mail: info@mentorconsulting.eu Web site: www.mentorconsulting.eu Some of the material shown herewith was created while working for: Domino Printing Sciences, Control Pharma or on behalf of Markem, EU Bridge and other organisations. Reference to Mentor Pharmaceutical Consulting in no way infers or implies that this presentations was given on behalf of Mentor or that any of the organisations shown are customers of Mentor at this point. These are organisations that members of Mentor have worked with and for over recent years. m e n t o r p h a r m a c e u t i c a l c o n s u l t a n t s 11 e x p e r t a d v i c e i n t r a c k & t r a c e , a u t h e n t i c a t i o n , r e g u l a t i o n , c o m p l i a n c e