Validation for BMS
Why BMS validation?
1-The objective to conduct validation is to produce documents evident which ensure high level of confidence.
2- ensuring system compliance.
3-reduce risk of failures.
4-assurance that will improve operational efficiency to process. Validation.
5-Validation is conducted to prove system functionality and consistently measure as per design specification.
6-Building Monitoring System (BMS) covers computerize system, network architecture, software as source code programming and instrumentations/ devices as controller (Input/output) whereas it is monitoring for GMP elements and Non-GMP elements. As parts of Code of Federal regulation, GMP elements/ critical areas are mandatory to VALIDATE.
7- There has to be segregation physically and logically between GMP and Non-GMP elements to avoid conflict of I/O. Regulatory Frame Slide .
Validation for machine
Target of validation is to make testing,IQ,OQ,PQ and commissioning for
System to sure of requirements & design achievement and comply
With CFR21 part 11 and GAMP5 .