The objective to conduct validation is to produce documents evident which ensure high level of confidence, ensuring system compliance, reduce risk of failures, and assurance that will improve operational efficiency to process. Validation is conducted to prove system functionality and consistently measure as per design specification.
Building Management 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.
We can provide operational resources and assistance with the generation of User Requirement Specifications (URS), through Commissioning and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Our qualified team can provide BMS Validation consisting of Installation Qualification (P&ID check, instrument check, wiring check, safety check and instruments calibration as well, …), Operational Qualification consists of System Operational test verification comparing with Functional Specification of the system as define in the System Design Specification. in addition to software validation.
Also we can provide customers with full support during inspection, testing, maintenance and compliance.
Our BMS free inspection will show you exactly the deviation in your system (if exist. After we’ve completed the evaluation and inspection, we develop and provide a scope-of-work document. It outlines the work to be performed, timeframe and cost for completing it.
Our regulatory for BMS Validation:
- FDA 21 CFR 11
- GAMP/5 ” Good Automated Manufacturing Practice”.
- ISPE Baseline, Vol.5 “Commissioning & Qualification”