ISA - 88 BATCH STANDARDS CD
ISA-88 Batch Systems Standards CD
inactive, Most Current
| Organization: | ISA |
| Publication Date: | 1 January 2006 |
| Status: | inactive |
scope:
About This updated CD compiles the essential ISA batch systems standards:
- ANSI/ISA-88.01-1995,
Batch Control Part 1: Models and Terminology (Formerly ANSI/ISA-S88.01-1995 ) - ANSI/ISA-88.00.02-20
01, Batch Control Part 2: Data Structures and Guidelines for Languages - ANSI/ISA-88.00.03-20
03, Batch Control Part 3: General and Site Recipe Models and Representation - ANSI/ISA-88.00.04-20
06, Batch Control Part 4: Batch Production Records - ISA-TR88.0.03-1996, Possible Recipe Procedure Presentation Formats
along with a compilation of over 20 ISA Technical Papers on batch systems control and excerpts from Applying S88: Batch Control from a User's Perspective, an excellent tool for better understanding the above standards.
Additionally, the CD contains other important items on batch systems control including:
- Batch XML schemas from World Batch Forum
- 21 CFR 11 on criteria for the FDA acceptance of Electronic Records and Signatures
- 21 CFR 210 on the good manufacturing practices in manufacturing, processing, packing or holding of drugs
- 21 CFR 211 on good manufacturing practices in pharmaceuticals
Document History
88 BATCH STANDARDS CD
January 1, 2006
ISA-88 Batch Systems Standards CD
About This updated CD compiles the essential ISA batch systems standards:
ANSI/ISA-88.01-1995, Batch Control Part 1: Models and Terminology (Formerly ANSI/ISA-S88.01-1995)
ANSI/ISA-88.00.02-2001,...