The Cardinal Source
Sourcing Brief
Stage 1 · North Star
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CCaaS migration sourcing brief.

Acme Manufacturing · 78 locations · FDA-regulated medical device

Engagement
CS-2026-014
Date issued
June 14, 2026
Client
Acme Manufacturing
Sponsor
VP, Information Technology
Industry
Medical Device Manufacturing (FDA, ISO 13485)
Scope
Contact center + voice infrastructure

Executive summary

Acme Manufacturing is replacing a legacy Cisco on-premises contact center across 78 locations. The current platform is end-of-life in 2027 and fails to satisfy three operational requirements: 21 CFR Part 11 audit trails for clinical-affairs inbound calls, HIPAA-aware call recording with discoverable transcripts, and integration with the company's complaint management system (MasterControl).

This brief reframes the request from "we need a new CCaaS" to "we need an FDA-aware contact center that supports 21 CFR Part 11 audit trails, HIPAA inbound handling, and MasterControl integration — deployable across 78 manufacturing and clinical-affairs sites without disruption to existing complaint-handling SOPs."

Outcome statement: Replace the contact center stack with a HIPAA + 21 CFR Part 11 compliant CCaaS solution that integrates natively with MasterControl, supports 360 concurrent agents across 78 locations, and reduces total cost of ownership by at least 18% over a five-year horizon.

Current state inventory

Incumbent platform

Cisco Unified Contact Center Enterprise (UCCE) 12.5, deployed 2017. On-premises infrastructure across two primary data centers (Indianapolis and Phoenix) with site survivability at 76 of 78 locations. End-of-software-maintenance scheduled for January 2027.

Contract structure

ComponentVendorAnnual costRenewal
UCCE Enterprise Licenses (360 seats)Cisco$485,0002027-01-15
Carrier voice (SIP trunking, 240 sessions)Lumen$168,0002026-09-30
Call recording (Verint)Verint$94,0002027-03-01
Workforce management (Aspect)Aspect Software$72,0002026-12-31
Total annual$819,000

Operational metrics (current)

What we are actually solving for

Three constraints define this engagement and shape every downstream decision:

Constraint 1 — 21 CFR Part 11 audit compliance

FDA inspection readiness requires that any system handling clinical-affairs or complaint-related communications produce tamper-evident audit trails. Most CCaaS vendors generate call recordings; few generate cryptographically-signed audit logs that satisfy 21 CFR Part 11 §11.10(e). The shortlist must include vendors with proven Part 11 implementations at peer device manufacturers.

Constraint 2 — MasterControl integration depth

Acme's complaint-handling SOP requires that every inbound complaint call be created as a MasterControl complaint record within four minutes of call termination, with the full transcript attached. Off-the-shelf API integrations exist for most CCaaS vendors but the field maturity varies widely. Shortlist must include vendors with production MasterControl deployments at scale.

Constraint 3 — Deployment risk tolerance

The FDA Form 483 risk associated with disrupting complaint-handling continuity is high. Migration cannot involve site-by-site cutover that puts any individual site offline for more than four business hours, and rollback to UCCE must remain viable for the first 90 days post-cutover at every site.

Success criteria

DimensionTargetMethod of verification
21 CFR Part 11 complianceAudit-ready by go-liveThird-party audit + FDA pre-inspection
Integration to MasterControl≤4-min call→record creationSLA monitoring during 30-day burn-in
Annual run-rate≤$671,580 (18% below current)Year-1 financial reconciliation
ImplementationAll 78 sites by 2026-12-31Site-by-site cutover plan + tracker
Operational continuityZero unplanned outage >4 hrIncident log review

Budget envelope

Year-1 implementation budget: $1.1M one-time (includes professional services, training, parallel-run period). Year-2+ run-rate target: $671,580 annually or below.

Approved by VP, Information Technology and CFO on 2026-05-22. Subject to revised approval if final TCO exceeds Year-2 target by more than 8%.

Stakeholders

NameRoleEngagement
[Redacted]VP, Information TechnologyDecision authority
[Redacted]Director, Quality AssuranceFDA / Part 11 validation
[Redacted]Director, Customer ExperienceOperational requirements
[Redacted]Manager, IT InfrastructureTechnical implementation
[Redacted]External counselContract review

Next steps

This Sourcing Brief is the Stage 1 deliverable in The Cardinal Method. Subsequent stages produce three additional deliverables: