Tech Transfer & Automation Alignment

Every tech transfer programme accounts for equipment, analytical methods, batch records and regulatory filings. Almost none treat the automation layer — the DCS that controls the process and the MES that records it — as its own discipline with its own gap analysis. It gets folded into a checklist, assumed to transfer cleanly, and reviewed by whoever has time. That’s how control gaps make it all the way to validation before anyone catches them.

Rockstone runs DCS and MES alignment as a dedicated workstream within your tech transfer programme — not a checklist item inside someone else’s scope. We pair process engineers, who understand the biology, chemistry and critical quality attributes behind the product, with automation engineers, who understand the control platforms inside and out. Every gap we identify and every alignment we deliver is reviewed through both lenses.

This pairing exists because the two questions that matter in a transfer — does the process behave the same way, and does the control system execute it the same way — are rarely answered by the same person credibly. A control loop, an alarm setpoint, or a recipe step can look equivalent in configuration and still fail to reflect the same process understanding. Catching that takes a process engineer and an automation engineer in the room together, not one person trying to be both.

This is the automation and controls layer of your transfer programme, not the whole of it. If your broader tech transfer covers analytical methods, raw materials, scale-up and regulatory filings, we plug directly into that workstream — bringing a level of rigour to the control system review that’s usually missing from a generalist gap analysis. Many transfers are also New Product Introductions (NPI) for the receiving site — the process may be established elsewhere, but it’s new to that facility’s DCS and MES. Where that’s the case, we extend our support beyond alignment into the system modifications needed to bring the new product onto the platform.

If your transfer needs full programme management — scheduling, stakeholder coordination, commissioning oversight — alongside the automation alignment, our Project Delivery team works the two in parallel. And every system modification we make is closed out through our CQV service, so validation stays joined up end to end.