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Your first consultationis free.
Whether it is one instrument, a site-wide program or a workflow that needs better software, start with a conversation. Tell us the pressure point and we will give you a practical next step.
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Let's scope it together.
Tell us what system keeps you up before an audit. First consultation is free, and scoped like everything else we do: you leave with a concrete assessment, not a sales pitch.
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pharmaedgge@gmail.comAttributable, legible, contemporaneous, original, accurate — we practice what we validate. Your details are used to reply to you and for nothing else.
Before you ask
Questions we hear in every kickoff
A few things clients almost always want to know before the first call. If yours isn't here, just ask in the form.
A single standalone instrument typically runs 2–4 weeks end-to-end; an enterprise system like LIMS or ERP runs 2–4 months depending on configuration depth. The assessment phase gives you a firm timeline before you commit to anything.
Yes — legacy remediation is a large share of our work. GxP-critical spreadsheets can be validated (or replaced with something better), and legacy systems can usually be brought to a defensible state without ripping them out.
Yes. Document authoring, reviews, risk assessments and most software validation run remotely. Activities that need hands on equipment — IQ walks, instrument OQ — we do on-site or guide your team through live.
It is built to be: audit trails, unique user credentials, e-signature manifestation and record protection are core architecture, and every product ships with its own validation package so your part of the compliance burden is already documented.
Both, appropriately. Our method is GAMP 5 risk-based at its core, which is exactly the direction FDA's Computer Software Assurance guidance points: critical thinking and testing where risk lives, less ceremony where it doesn't.