What the scorecard covers
The workbook has two tabs. An Instructions tab explains how weighting and 0–5 scoring work and walks a worked example. The scorecard tab lays out eight weighted dimensions, a 0–5 dropdown for each of up to three vendors, a check that your weights total 100, and an automatic weighted score out of 100 for each vendor — so the sheet ranks them for you.
The eight dimensions are the ones that actually decide a regulated deployment: electronic records and signatures under 21 CFR Part 11, validation and CSA/CSV support, audit trail and data integrity, core QMS workflows, integrations, implementation and support, security and hosting, and total cost of ownership. Each row tells you the evidence to demand, so you score what a vendor can prove rather than what they claim.
- Electronic records & signatures — a non-editable audit trail and compliant e-signatures, shown not asserted
- Validation & CSA / CSV support — a real validation package or documented approach, not a certification badge
- Audit trail, data integrity, and core QMS workflows connected end to end
- Integrations, implementation & support, and security & hosting (ask for the SOC 2 / ISO 27001 report, not the logo)
- Total cost of ownership over 3–5 years — plus a weighted score out of 100 that ranks each vendor automatically
Why weighting beats a feature checklist
A plain feature checklist treats every requirement as equal — so a vendor can win on a long list of nice-to-haves while quietly failing the two or three things that would sink your next inspection. Weighting fixes that. By deciding up front what matters most and scoring against evidence, you get a comparison that reflects your regulatory reality, not the vendor's demo script.
It also makes the decision defensible. When a steering committee or an auditor asks why you selected a vendor, a weighted scorecard with recorded evidence in the Notes column is a far stronger answer than a gut feel. The score is only as good as the honesty of the inputs — which is why every dimension here points you at the artifact to demand, and why GAMP 5 thinking (risk and evidence, not assertion) runs through the whole sheet.
Already know Part 11 is the priority?
This scorecard is deliberately broad — it compares vendors across the whole eQMS, from workflows to TCO. If your evaluation is driven specifically by 21 CFR Part 11 and you want to interrogate a vendor clause by clause, use the companion 21 CFR Part 11 RFP Scorecard instead — it drills into each Part 11 control with the exact question to ask and the disqualifying failure to watch for. Many teams use both: this one to shortlist, the Part 11 scorecard to pressure-test the finalists.
