Michael Schwarz EMEA Product Marketing

The target: Regulated industries There are industries which are specifically regulated to ensure end- customers safety (protection of human health and life): Food Pharma

The Business opportunity Regulations require efforts which do not add value to the product. Wonderware offers functionality which lower the cost in fulfilling regulation requirements

Regulations do traditionally exist For both, Food and Pharma, so called Good Manufacturing Practices (GMP) exist GMP define what should be done and what to take care of, when producing Food- and Pharmaceutical goods GMP is a continuous updated state of the art definition

Pharma industries needs validation Producers of Pharmaceutical products have to be certified that they follow GMP in production (valid for Europe) Certification require Validation process (Audit) Requires: Plant specification under GMP Build plant following spec Testing to ensure production procedures follow spec and GMP Document and ensure quality of production continuous

Food manufacturing Food manufacturing has to follow the GMP by law Food manufacturing does not require any “validation” process Food manufacturers are often requested by retailers (mostly supermarket chains) e.g. to ensure quality by ISO 9000 ff which requires a audit and certification

Critical issues showed weaknesses Critical situations in Europe like the Mad Cow disease showed that it is very difficult to track products and materials along the supply Chain to identify risk to end users Result: Identification of effected products and non effected products not possible Call back of all products Scrap total production (goods)

The Consequence To be able to ensure safety and identify effected products, - retailer organizations - and the European Community started Food safety initiatives:

European Food safety initiatives Public: REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT ESFA (European Food safty authority) Private: GFSI (Global Food Safty Initiative) IFS (International Food Standard) BRC (British Retailer Consortium) ( released GLOBAL STANDARD - FOOD …… The food and even the fed market is facing requirements in certification from private organizations and law enforcement. Reason for these initiatives are the critical situations in the last years where mad cow disease or Mouth and foot disease which showed up that the existing procedures for product traceability and the possibility to identify sources of material or ingriedience. Motivation behind these initiatives are to be able to control such a critical situation or make sure that quality of delivered or sold products is ensured or contaminated or hazardous products can be identified and called back without affecting the brand or reputation. (c) 2002 Invensys Systems, Inc. 9-Jan-18

EU Regulation No 178/2002 Some key elements … feed manufacturers, farmers and food operators have the primary responsibility for food safety; A successful food policy demands the traceability of feed and food and their ingredients. (c) 2002 Invensys Systems, Inc. 9-Jan-18

Article 18 Traceability 1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution.

Article 18 Traceability 2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand.

Article 18 Traceability 3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.

Traceability Document noteworthy events or action- Document material consumption including material identification- Documents critical quality values along the production process- ….for products and material. (single product or defined lot of products)

EU Regulation No 178/2002 REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety Existing food law principles and procedures shall be adapted as soon as possible and by 1 January 2007 at the latest in order to comply with Articles 5 to 10. (c) 2002 Invensys Systems, Inc. 9-Jan-18

The business opportunity Traceability required! (product focused production process-, material consumption and quality measures documentation) Cost effective solutions preferred: high automation level possible, allowing cost savings by avoided call backs, and reduced documentation efforts…

The Wonderware offering Wonderware’s FactorySuite offers cost effective solutions to automate product tracking and paperless documentation for regulated food environments. FactorySuite covers functionality in continuous, Batch, Discrete and hybrid manufacturing processes.

Information Integration for traceability SV Industrial Portal ERP/SCM/CRM data Order Number/Serial Number in Question Bill-of-Materials, Routing for product Product Structure A2 Application Server InSQL QI Analyst InBatch InTrack InTouch Wonderware Order Execution Production Model used to control production Genealogy Consumption Records of part or lot Production History Complete as-built history and actual routing of part or lot Event Data Alarms, Failures, and Maintenance during production of part Product Quality Sample inspection and conformance data of part Process Quality SPC Alarms, shifts and trends during production of part Process History Trends/data of process conditions during production of part (c) 2002 Invensys Systems, Inc. 9-Jan-18

Value using Wonderware Software Secured Productivity and Profit by automation based traceability. Lower costs and shorter implementation by leveraging standard software capabilities Low cost device integration for data collection

Benefits of a Software solution No manual operator procedure necessary No paper based system Reports on demand

Regulated Industries Wonderware is committed to meeting the needs of regulated industries Successful implemented functionality to lower the implementation and maintenance costs of applications in regulated environments (Food and Pharma) Rügenfisch success story IFS (International Food Standard) certified

Dedicated Traceability offering Wonderware will release a set of Objects and a database model for Traceability requirements New offering Industrial Application Server based Targeted for the food market

Marketing activity example Taken from “wired” a weekly newsletter send by Pantek UK

Powering intelligent plant decisions in real time. (c) 2002 Invensys Systems, Inc. 9-Jan-18