What the scorecard covers
Sixteen control areas spanning §11.10(a)–(k) (validation, record copies, retention, access control, audit trail, sequencing, authority checks, device checks, training, signature policies, documentation control), §11.50 signature manifestation, §11.70 signature binding, and the §11.100–§11.300 signature and credential controls.
Each row carries four working columns — the RFP question, the artifact to demand, the disqualifying failure mode — plus Pass / Partial / Fail dropdowns for three vendors and a notes column. An Instructions tab explains the scoring discipline, and a worked example row shows what a completed entry looks like.
- §11.10(a)–(k) system controls, from validation to documentation control
- §11.50 signature manifestation and §11.70 signature binding
- §11.100–§11.300 signature and credential controls
- RFP question, artifact to demand, and disqualifying failure mode per row
- Pass / Partial / Fail scoring columns for three vendors
Why score against artifacts, not answers
Every vendor answers “yes” to “are you Part 11 compliant?” — a question that doesn't even make sense, since no software is compliant by itself. The artifact discipline fixes that: an audit-trail sample either shows create / modify / delete events or it doesn't; a signed-record export either displays name, date, and meaning of signature or it doesn't. Scoring what the vendor produces removes the marketing layer from the evaluation.
Using the scorecard in a real evaluation
Send the question column to every shortlisted vendor in the same RFP, demand the artifacts in the same format, and score in one sitting so the comparison stays calibrated. Complere's own answers to every row are demonstrated live in a validation-focused demo and bring the scorecard.
