Doc: ps2001-5-1101-001 Rev: R02. 00
Download 1.5 Mb. View original pdf
|
1486357009-URS, URS
| Training and support (1) Users of the library will be trained in its deployment and use. (2) The User Guide (UP, [Ref. 006] , see § 4.6.7, will form the basis of all training. (3) The test rig (see § 3.1) will provide the necessary training platform, allowing various scenarios and applications to be demonstrated and developed. 5.5 Restrictions and limits of use (1) Only the validated version of the software library must be used (see § 4.11.2). (2) The software must not be deployed on high-speed applications (e.g. bottling machines, paper mill c. The software must not be used on system that require a response time of less than 100 ms. Doc PS Rev R 69-71 6. References and glossary 6 References and glossary 6.1 References The following documents are referenced in this manual REF DOCUMENT NO. AUTHOR TITLE/DESCRIPTION 001 PS PSP Quality Plan (QP) 002 PS PSP Validation Plan (VP) 003 PS PSP User Requirements Specification (URS) – This Document 004 PS PSP Style Guide (SG) 005 PS PSP Operation & Maintenance Manual (OM) 006 PS PSP User Guide (UG) 007 GAMP 5 ISPE Good Automated Manufacturing Practice 008 IEC6113-3 IEC Programmable controllers - Part 3: Programming languages 009 CFR 21, Part 11 US CFR US Code of Federal Regulations, Title 21, Food and Drugs, Part 11 – Electronic Records, Electronic Signatures 010 EudraLex Vol 4 Annex 11 EU Regulations Vol 4: Pharmaceutical legislation – Medicinal Products for Human and Veterinary use – Good Manufacturing Table 6.1 Table of references |