Qualified BMS (QBMS)

It’s our modus operandi … and we’d like to help to make it yours. Our QBMS engineers will guide you through your building automation project and save you time by providing testing templates approved by your industry peers.

A Qualified Building Management System (QBMS) or Qualified Building Automation System (QBAS) 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

Our suite of document templates has been approved by numerous pharmaceutical clients and is constantly being updated. Sirus’ QA team attend regular training and seminars to keep up to date with the regulations and auditing bodies such as EMA and FDA and can guide our clients in line with them. Sirus are members of ISPE, the authority who provide support for FDA and authors of GAMP 5 Guidance Documents.

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.

Constructive Workshops

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

Contact Us

Get in touch by phone or email and we’ll arrange a consultation to discuss your QBMS requirements.
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Tender Process

Our QA Team and the client’s QA Team are generally involved of the tender process.

Project Phase

For us, every project is delivered following the same phases from planning to practical completion.

Maintenance

Sirus have a strong focus on maintenance and full lifecycle support of your facility.

Sirus Ireland
Sirus House

Unit 13, The Westway Centre
Ballymount Avenue
Dublin, D12 FW63
Ireland

+353 1 460 2600
+353 1 450 7968
info@sirus.ie

The Well

Unit 2018, Orchard Avenue
Citywest Business Campus
Dublin, D24 FR88
Ireland

+353 1 450 7968
info@sirus.ie

Sirus Cork

Unit 5, Centrepoint
Marina Commercial Park
Cork, T12 H7DV
Ireland

+353 21 4315552
+353 21 4315556
info@sirus.ie

CMC House

Unit 4, Eastgate Way
Eastgate, Little Island
Cork,
Ireland

+353 21 435 1090
info@sirus.ie

Let’s talk about your project!