Working notes on operations, change, and system decisions in regulated Life Sciences — written from the client's side of the table by the people who do the work.
Hiring an advisor is itself an unadvised decision. Competitive bids and reference checks do not separate the firms — every serious one clears them. These nine questions do.
Design an advisory firm today — no legacy, no bench, no partner comp plan to protect — and you would not build what currently exists. Six structural choices, and the refusals that go with them.
The consulting pyramid was an answer to the price of two inputs — retrieval and production. Both just got cheap. What that changes for anyone buying advice.
A validation pack is not a methodology. These five artifacts carry an inspection — and each one fails in a predictable place.
After fourteen years, the EU's rulebook for computerised systems is being rewritten — and it grew from five pages to nineteen. If you are buying or validating an ERP, the draft already tells you where to build.
CSA didn't lower the bar. It moved the effort to where the risk is. A year on, the most common misreading is still costing regulated companies time and defensibility.