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ISA approves merger with OMAC

ISA—The Instrumentation, Systems, and Automation Society's Executive Board today approved its merger with OMAC—The Open Modular Architecture Controls Users' Group. OMAC will now act as a subsidiary of ISA. "OMAC has been blessed with the active participation of a dedicated group of volunteers from numerous end user companies, automation suppliers, and OEM's over its past eight years or so of informal existence," said OMAC Board Chair Andy McDonald of Unilever. "We are delighted that we are now affiliating with such a respected and established organization as ISA. It should help OMAC achieve even more success in establishing guidelines in areas such as packaging, computerized numerical control, and manufacturing architecture."

"ISA is excited about the opportunity to work more closely with the members of OMAC to establish consensus industry standards for the manufacturing community," said ISA President Donald Zee. "The guidelines that OMAC has established have greatly facilitated more efficient and effective manufacturing. They serve as an excellent complement to ISA's legacy of useful industry standards, and we look forward to working together in the future."

"ARC has been working with both groups for many years," said Dick Hill, vice president at Dedham, Mass.-based industry research firm, ARC Advisory Group. "Both OMAC and ISA are respected for helping achieve consensus and direction in the automation community. They have respective strengths in the discrete and process industries. By joining forces, they are positioned to leverage those strengths to become even more effective in serving the needs of automation professionals and manufacturing industries."

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New versions of BML and B2MML available

BatchML is an XML implementation of the ANSI/ISA 88 family of standards (ISA-88), known internationally as IEC 61512. BatchML consists of a set of XML schemas written using the World Wide Web Consortium's XML Schema language (XSD) that implements the models and terminology in the ISA-88 standard. B2MML is an XML implementation of the ANSI/ISA 95 family of standards (ISA-95), known internationally as IEC/ISO 62264. New versions of BML and B2MML can now be downloaded.

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Download for free: the PFC symbols (ISA-88.02 Master Recipes) in Visio template

Part 2 of S88 provides standard symbols for the depiction of S88 Master Recipes. For the development of these recipes you can get a Visio template at TWP Training. The template is free of charge. You will need the program Visio to be able to use it.

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ISA-88 part 3 about General Recipes accepted by IEC

Recently ISA has published part 3 of the ISA-88 standard. This part provides the detailed definition of the content of a general recipe. What format should this information take? How do we draw it or write it down so everyone understands it? How should the information be structured? It also provides a methodology of a conversion of a general or site recipe to a master recipe. “This presents the possibility of having a single corporate wide recipe for a product that can be rolled out to a large number of local manufacturing plants with assurance the product will be the same in each location”, according to Lynn Craig, the committees chairman (Intech). Up till now there was no accepted method for depicting a general recipe in a consistent manner and no generally accepted method of going from general and site to a master recipe. ISA-88 part 3 provides the solution to this problem. The standard has recently been accepted by the IEC and has thus become an international standard. The standard can be downloaded.

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Download for free: example of Risk Assessment based on GAMP4

The AllMons consultants have developed and example of a Risk Assessment based on GAMP 4. This example makes clear at which phases in automation projects you can apply a Risk Assessment. Risks of the defined functions are estimated and validation effort and pay back time of the investment are decreased. The investment of a Risk Assessment will be paid back in a short time.

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English-spoken training courses about ISA-88 and ISA-95

TWP Training, an ISA certified company, provides English spoken training courses and seminars about the ANSI/ISA S88 standard and the ANSI/ISA S95 standard. These courses are not scheduled on a regular basis, but they can be provided as on site training courses in several countries. For more information about the possibilities, contact TWP Training.

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Training course GAMP, Validation and 21CFR11

In addition to the ISA-88 and ISA-95 training courses and seminars, TWP training also offers a training course and workshop about Gamp, Validation and 21 CFR 11. These English spoken training courses are not scheduled on a regular basis, but can be provided as on site training courses in several countries. The class presents the definition of validation in USA FDA regulated manufacturing, and the methods that must be used to have a validated system. GAMP is described and is presented as a guideline for development of validation processes for a wide range of control systems.

The class also presents an overview of the requirements placed on manufacturing in pharmaceutical and biotech for the USA FDA regulated markets. It describes the requirements for electronic records and electronic signatures as specified in the USA FDA 21 Code of Federal Regulations, Part 11. This regulation describes the controls and procedures that must be placed on information maintained in electronic form and on electronic documents used in place of officially signed documents.

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New training possibility: ISA-88 and ISA-95 FlexTraining

Suddenly your company needs to know more about the ISA-88- or the ISA-95 standard, about 21 CFR 11 or about GAMP and validation. You’re in a hurry, so you don’t want to wait for the next course date of the ISA training courses. But you do not have enough employees to organize an official In company training course. TWP training can help you solve this problem with its new kind of education: FlexTraining.

FlexTraining is a combination of training and consultancy (a workshop). Just call TWP training and they will provide you the needed information as soon as possible. The contents, duration and level of the FlexTraining will be fine tuned with your companies needs. If necessary, the trainer-consultant will pay attention to specific problems that you are dealing with in your projects. The training can take place at your company’s site, or somewhere else.

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New part of ISA-88 about Production Records

The ISA-88 committee has started the development of a new part: ISA-88 part 4. After part 1 about models and terminology for batch control, part 2 about data structures and guidelines for languages and part 3 about General Recipes, part 4 is about production records. Draft 6 was finished recently. Once finished, the document will define a reference model for production records, which contain information about batches and production segments.

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Interesting discount: subscription to ISA standards

At ISA it is possible to get a subscription on the more than 100 ISA standards, like ANSI - ISA S88 and ANSI- ISA S95. This subscription will give you the possibility to access all the ISA standards on line, and you have permission to download up to 10 standards a year. The costs for non-members is 900,00 a year. ISA members get a significant discount, they only have to pay 95 dollars a year. For more information: : www.ISA.org.

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