Control strategies get overcomplicated fast. Teams drown in jargon, giant trace matrices, and “one more spreadsheet.” But auditors (and operators) care about something much simpler:

Can you show quickly and consistently what you control, who owns it, and where the evidence lives?

This post lays out a practical approach that scales from development into commercial manufacturing.

The core idea (in one line)

CQA → CPP/CMA → control layers → owner/approvals → evidence

If you can’t trace your strategy end-to-end, it won’t scale—and it won’t hold up under scrutiny.

Step 1: Start with CQAs (what must be true for the patient)

CQAs are the outcomes you’re protecting: identity, strength, purity, sterility assurance, content uniformity, etc.

Practical rule: write each CQA in plain language:

  • What does “good” look like?
  • What would “bad” mean for patient impact?

If you can’t explain a CQA without acronyms, the map will turn into paperwork instead of control.

CPPs and CMAs are the levers that meaningfully move CQAs.

Keep it honest:

  • If it doesn’t move a CQA, it’s not a CPP/CMA—it’s noise.
  • If it moves a CQA, it needs a control layer you can defend.

Step 3: Define control layers (controls exist in layers, not one test)

Most failures come from “single-point control thinking”:

“We test it at the end, so we’re fine.”

That doesn’t scale. Robust control strategies use layers, for example:

  • Material controls (supplier qualification, incoming acceptance)
  • Process controls (setpoints, alarms, in-process checks)
  • Procedural controls (SOPs, training, line clearance)
  • Analytical controls (IPC testing, release testing)
  • System controls (access, audit trails, data integrity)

Goal: multiple independent ways to prevent/detect a bad outcome.

Step 4: Assign owners + approvals (RACI that isn’t theater)

A control strategy fails when ownership is ambiguous.

At minimum, capture:

  • Owner: accountable for control performance & upkeep
  • Approvers: who approves changes (QA, MSAT, Validation, etc.)
  • Escalation path: who gets called when limits are breached

If an auditor asks “who owns this control?” your answer should be immediate.

Controls don’t exist unless you can produce evidence.

For each control layer, link:

  • The record type (batch record section, log, system report)
  • The system of record (eQMS, MES, LIMS, historian, DCS, etc.)
  • The retention expectation (as applicable)
  • The retrieval path (who pulls it, how long it takes)

Fast test: can your team retrieve a representative record in under 10 minutes?

Step 6: Review cadence + triggers (change control is your friend)

A control strategy should be reviewed on purpose, not “when someone remembers.”

Use:

  • Periodic review (quarterly/ annually depending on risk)
  • Triggered review at change control events:
    • material/supplier change
    • parameter range change
    • equipment/software change
    • deviation trend/complaint trend
    • method change

This is how you keep the strategy aligned to the validated state.

Common failure modes (what breaks first)

In practice, traceability usually breaks at: 1) Handoffs (development → tech transfer → commercial) 2) Ownership gaps (everyone is involved, nobody is accountable) 3) Evidence sprawl (records scattered across systems) 4) “One test” thinking (weak layering) 5) Unmanaged change (strategy doesn’t update when reality changes)

A simple audit question to pre-answer

“Show me how this CQA is controlled, and prove the controls are working.”

If you can answer that with:

  • the map
  • named owners
  • linked evidence
  • review history

…you’re in a strong position.

Question for you

Where does your traceability usually break first, process controls, test strategy, or documentation handoffs?