DD IEC PAS 61512-4 : DRAFT 2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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BATCH CONTROL - PART 4: BATCH PRODUCTION RECORDS
31-12-2010
23-11-2012
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Batch production record description
4.1 Introduction
4.2 Batch production record
4.3 Batch production record purpose
4.4 Batch production record data management
4.5 Batch production record structure
4.6 Production information
4.7 Batch production record elements
5 Batch production record object model
5.1 Introduction
5.2 Modelling information
5.3 Batch production record object model overview
5.4 Batch production record
5.5 Batch production record entry
5.6 Event
5.7 Data set
5.8 Comment
5.9 Sample
5.10 Change
5.11 Personnel identification manifest
5.12 Resource qualification manifest
5.13 Product definition
5.14 Production response
5.15 Production request
5.16 Control recipe
5.17 Recipe element
5.18 Master recipe
6 Completeness, compliance and conformance
6.1 Completeness
6.2 Compliance
6.3 Conformance
6.4 Extending the object model
Annex A (informative) - Data modelling technique
Annex B (informative) - Questions and answers
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