A Qualified Building Management System (QBMS) (aka Qualified Building Automation System (QBAS) or Validated BMS) is a system that controls conditions in critical areas where critical processes reside e.g. cleanrooms, cold storage or freezers in pharmaceutical plants.
The Qualified BMS controls and monitors critical ambient conditions to ensure product quality.
Some pharmaceutical plants require fully Qualified BMS where others opt for Qualified Rooms or Qualified Sections in the drug storage warehouse, depending on the criticality of the area of the system.
Through the years, Sirus has developed procedures and a robust system for qualification. This means that our clients can leverage Sirus’ testing protocols for internal testing and qualification.
Sirus’ testing procedure has four mandatory testing protocols for Qualified BMS: HFAT, SFAT, Hot Loop Checks & SAT. All tests and changes to the QBMS require a witness signature from the client company.
Our clients tend to reference Sirus documents throughout their own documentation. The upshot of this is a smaller number of documents to maintain on the client’s side and a lot of time saved.
Tried and Tested
Patience is a Virtue
Change control is a much longer process for QBMS. Every change has to be pre-approved, approved and signed by the client to close out. Sirus engineers have the expertise and skills (including patience) required to work in the pharmaceutical environment. All Sirus engineers and technical writers are trained in Qualified BMS from the start so we have a large pool of QBMS engineering resources available.
From the outset of every project, Sirus schedule constructive workshops with the client to develop project expectations. Sirus’ Quality Assurance (QA) Team take the time to understand the clients quality plan, see where our templates fit and further develop templates where required.
Here’s how Sirus can help you with your Qualified BMS
Help to manage RTM based on URS
We find that clients can experience difficulty understanding how to manage a Requirement Traceability Matrix (RTM) based on a User Requirement Specification (URS). For this reason, Sirus offer guidance or to manage these documents on your behalf from the beginning of the project.
Save time developing tests
Sirus has developed a set of robust testing templates over the last 10 years which our clients can use. These templates are constantly being updated to stay in line with Good Automated Manufacturing Practice (GAMP 5) and the European Medicines Agency (EMA) standard.
Save review time
Continuously reviewing testing protocols can be painstaking and time-consuming. Sirus can save you review time on testing protocols by getting you to review and pre-approve our templates from the beginning of the project.
Your QBMS Project Plan
Our QA Team and the client’s QA Team are generally involved of the tender process.
Sirus’ Qualified BMS Case Studies
Let’s talk about your project!