Auditors Don't Care That You Were Going to Update the DHR. They Care That You Didn't.
Medical device manufacturers face document control requirements that generic ERP doesn't address. Every FDA inspection turns on whether your DHR is current, your 21 CFR Part 11 e-signatures are real, and your CAPA records are closed — not whether you had good intentions. Doc-Trak configures those requirements directly inside SyteLine so audit readiness is built into how your shop runs, not rebuilt the week before an inspection.
40+ Years as SyteLine Partner | Infor Gold Partner | 800+ Manufacturers Served
What FDA Audit Risk Actually Looks Like Inside an ERP System
Your DHR and DHF are in SyteLine. Your document revisions are not.
Design History Records require current document revisions attached to every production lot. If document control lives outside your ERP, every audit requires manual reconciliation — pulling records from email threads, network drives, and engineering inboxes to prove the right revision was on the floor.
Doc-Trak's auto-attach rules link drawings, work instructions, and SOPs to active builds by part number, customer, or order. When a revision lands, every affected build picks it up automatically.
21 CFR Part 11 requires e-signatures. Paper substitutes create 483 risk.
FDA expects electronic signatures tied to specific records with unique user authentication, a timestamp, and an audit trail. Scanning a wet signature and attaching it to an email does not meet that standard — and FDA investigators know the difference. Cobbling together compliance from spreadsheets, email approvals, and scanned forms is how 483 observations happen.
Doc-Trak supports 21 CFR Part 11 electronic signatures and audit-trail capture as part of the document control workflow, configured to your validation scope during implementation.
CAPA cycles take 60+ days in most shops. Most of that is documentation routing.
Corrective and Preventive Action workflows require documented root cause, corrective action, verification, and closure — all with electronic evidence. When CAPA lives in a separate spreadsheet or bolt-on QMS, the data never connects to the production event that triggered the nonconformance.
Native SyteLine CAPA workflow ties corrective action to production data. Fact-Trak surfaces CAPA cycle time, NCR rates, and scrap by lot alongside program margin so the financial cost of quality problems is visible, not buried in a separate quality report.
21 CFR Part 11 and DHR/DMR Requirements — What Doc-Trak Configures in SyteLine
| Control | What Doc-Trak Configures |
|---|---|
| DHR Currency | Design History Record document attachments linked automatically to production lots in SyteLine. When a revision lands, every active build referencing the affected part picks it up — no manual reconciliation required at audit time. |
| 21 CFR Part 11 E-Signatures | Electronic signature workflows with unique user authentication, timestamp, and record reference on every approval event. Configured to your validation scope during implementation. Audit trail captures identity, action, and record reference for every signature event. |
| CAPA Workflow | Structured CAPA cycle configured to your existing SOP — electronic routing, stage gates, and escalation timers. CAPA tied to the production nonconformance that triggered it so root cause and corrective action stay connected to the shop floor event. |
| DHF Control | Design History File documents controlled by revision with access logs on every view and download. Drag-and-drop filing routes new files to the right repository based on auto-attach rules. |
| Lot/Serial Traceability | Doc-Trak and SyteLine share the same lot/serial records — full lifecycle traceability from supplier raw material through finished device to customer shipment. No cross-system reconciliation required at audit time. |
40+ years supporting medical device manufacturers and regulated manufacturers in the Midwest.
Lake Companies is an Infor Gold Partner focused exclusively on discrete manufacturing — every implementation we deliver is on SyteLine, for manufacturers who make things. SyteLine has been named a Gartner Magic Quadrant Leader for Cloud ERP for Product-Centric Enterprises five consecutive years through 2025. References available upon request.24
Hours to Audit-Ready
DHR, DHF, and CAPA records accessible without manual reconciliation
21 CFR Part 11
Compliant
Every approval event logged with user identity, timestamp, and record reference
Doc-Trak for Medical Devices — What It Configures
Quality analytics and financial analytics belong in the same view for medical device manufacturers. Fact-Trak surfaces CAPA cycle time, nonconformance rates, scrap by lot, and supplier quality trends alongside program margin and contract-level cost. When quality problems drive financial consequences — and they always do — they show up together, not in a separate quality report that never reaches the CFO.
Medical device component supply has its own scheduling complexity: approved supplier lists that take time to expand, regulated components where substitution isn't freely available, and quality holds that move material in and out of available inventory faster than standard MRP can track. APS-ME sets up SyteLine's existing APS module to handle those constraints — implement-or-optimize methodology whether you're new to APS or fixing a setup that hasn't worked under medical device realities.
Book a Document Control Readiness Assessment
Doc-Trak is the foundation. Shop-Trak traceability and Fact-Trak quality analytics build on it — all inside the same SyteLine environment, no integration overhead.See the full Trak-Suite story →