Commissioning and validation overlap: Many projects still suffer from repetitive testing. Once facilities are turned over and clients begin qualification testing and validation, they’re actually duplicating many of the tests previously handled during commissioning. But under the more recently rolled out ASTM E2500 standards, QA can be brought into the process during commissioning (mitigating the need for repeat tests later on).

Rigid testing timelines: Traditionally, installation qualification is followed by operational qualification and, finally, performance qualification. This sequential approach creates unnecessary bottlenecks—given the nature of IQ tests, there is no need to have them block OQ from starting sooner. Instead, most IQs (e.g., drawing and field checks) can begin before mechanical completion. Including less specificity in your test plans also creates valuable flexibility for commissioning teams to get IQ/OQ done quicker.

Data acquisition delays: A full roster of stakeholders are involved in the startup of any capital project such as general contractors, design-build teams, commissioning groups, and client maintenance teams—and everyone needs data from someone else to get their work done. The quicker you can get data into the CMMS, the better. For commissioning teams, this means collecting accurate asset data from the builder as early as possible, including unique IDs, manufacturer model and serial numbers, recommended maintenance information, and spare part numbers.

Lack of industry-specific builder knowledge: Builders know how to start up a new facility, but that doesn’t mean they are familiar with the nuanced documentation requirements that go into completing a life science facility. Commissioning teams should be brought in early to train and communicate with stakeholders before construction. so that everyone knows documentation requirements to satisfy FDA regulations. When possible, provide prior examples to demonstrate exactly what you’re looking for.

Resource constraints: Both on the client and vendor sides, bandwidth stands in the way of efficient IQ/OQ. General contractors may struggle to bring vendors on site to complete scope, delaying commissioning teams and forcing more work to happen in parallel. Client teams are already taxed for time, making it difficult to get timely approvals throughout a project’s life cycle. This underscores how crucial it is to communicate effectively and reduce the volume of testing (and approvals) happening simultaneously.

FDA approvals: Whether you are building out a new facility or expanding an existing one, there are steps you can take to expedite the FDA’s on-site audit. Start by studying similar manufacturing processes or devices that have already been approved and replicate their approach. Do not shy away from IQ/OQ templates either, which can speed up approvals compared to using documents that try to reinvent the wheel. You might also prioritize partial facility approvals, rather than waiting for an entire space to be delivered. The Q&A section of the Streamlining IQ/OQ for Efficient Delivery webinar, goes into a bit more detail about this.