Doc: ps2001-5-1101-001 Rev: R02. 00
Messages (alarms, warnings and prompts)
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1486357009-URS, URS
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- Modes of operation
- 4.10 Regulatory requirements and standards 4.10.1 Regulation and legislative requirements
| 4.9.3 Messages (alarms, warnings and prompts) (1) Each module will produce its own messages and these may be contained within a structure that is associated with that module. The supervisory system may require that these messages are coordinated into a common interface area, this approach will be permitted, and application modules will be designated for such coordination. (2) The management of messages is largely dependent on the supervisory system being used, and need not be considered here other than to say that modules will produce alarms, warnings and other messages and this maybe a consideration when selecting a supervisory system. 64-71 Doc PS Rev Rb Modes of operation (1) Consideration shall be given to the mechanisms and approaches needed to allow the operator to issue commands to instruments, devices and other aspects of the control system, this may include things such as • Face plates • Command screens • Button bars (2) The issuing of commands shall be consistent in appearance and approach for all standard modules. 4.10 Regulatory requirements and standards 4.10.1 Regulation and legislative requirements (1) There are two specific sets of regulations that apply to control systems in pharmaceutical environments • CFR 21 Part 11 US Code of Federal Regulations, Title 21, Food and Drugs, Part 11 – Electronic Records, Electronic Signatures Ref. 009] • EudraLex Vol 4 Annex 11 EU Regulations Volume 4: Pharmaceutical legislation – Medicinal Products for Human and Veterinary use – Good Manufacturing Ref. 010] (2) Generally, if a system is compliant with GAMP 5 it will satisfy the EU Regulations Volume 4, Annex 11 23 There are some additional documentation requirements and these are specifically addressed in the Project Validation Plan (VP, Ref. 002]. Doc PS Rev R 65-71 (3) CFR 21 Part 11 is concerned with the accuracy, reliability and storage of electronic signatures this is more relevant to supervisory systems rather than the Controller software of this Project however, were applicable the PAL software will comply with these regulations. (4) The legislative and regulatory requirements for the software are set out in this section and the software shall comply with these requirements (5) In addition to the legislative and regulatory requirements, the software will also conform to the standards specified below Download 1.5 Mb. Share with your friends:
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