Monthly plan vs swabs logged (Tables I–II) and above-limit results (Tables III–IV). Below: repeat fails and fail % by zone.
Table and zone apply below. Annually when From→To is 12+ months (any years). Logged = swabs in full range.
From Setup (Active = Yes): column 1 Zone, column 2 Assigned to Zone, then Facility Locations, Equipment, and Equipment Component.
Monthly plan from Tables I–II (test type and count per zone) distributed across items assigned in Setup → Location → Zone. Each month rotates to different assigned sites so the full year covers every location in the zone.
Users & Tab Access first, then SOP Tables I–IV, program review, and training per SOP FS 2.4.8.
Select an employee from the approved Employee List, then assign username, role, and tabs. Users cannot be created without an employee.
Choose Role = User, then check which tabs this person can open.
Tables I–IV drive compliance and PASS/FAIL. Save each table below when you change numbers.
Gray = no test. Enter 1 or more in a cell to activate (green). Clear or 0 for gray.
Zones use commas (e.g. 1,2 or 2,3,4). Pathogen rows stay Negative.
Document periodic review of the environmental monitoring program.
Default per SOP: Quarterly. Saved to program setup and used for dashboard alerts.
Choose a name and click Add to review for each person who participated. First name listed is the lead reviewer.
How to upload: choose file(s) → Upload selected files → wait for 100% and ✅ Uploaded in the table → Save Program Review. PDF / Word / Excel, up to 25 MB each. Files over ~3 MB try cloud storage first (faster); otherwise saved in parts (may take several minutes — keep the tab open).
After upload, files appear here. Click the file name to open PDF/Word/Excel. You must still click Save Program Review below to keep them.
Past reviews are listed here. Column Docs shows how many files — click the link or Edit to open attachments again.
Document training for personnel who perform environmental swabbing. Qualified trainer per SOP.
Defines who verifies records by module, facility location, location, or environmental zone. Performers cannot choose a verifier — assignments apply automatically on each tab.
Each Equipment Component (shared catalog) is assigned to one Equipment (shared catalog). Select the component first, then the equipment it belongs to.
Saved links between component and equipment. Click a column header to sort.
Each Equipment (shared catalog) is assigned to one Facility Location (shared catalog). Select the equipment first, then the facility location it belongs to.
Each Facility Location (shared catalog) is assigned to one Location (shared catalog). Select the facility location first, then the location it belongs to.
Select Coverage Type, then the matching item from the shared catalog, then assign it to one Environmental Zone.
Select Sampling Site (same list as On-Site Testing) — fields fill from the site and the latest on-site test for that site.
Log swabs for sites assigned in Setup → Location → Zone. PASS/FAIL uses Tables III–IV for that site's phase.
1 - Save record first, then proceed to step 2.
Save the fail record below to continue.
2 - Please notify your supervisor of the result.
4 - Production release
Complete step 3 — all required resamples must pass before release.
Minimum 5 vector samples in starburst around the positive site.
Link to Inventory lot when product impact is confirmed or under investigation.
Parent FAIL / pathogen records until SOP closure: vectors (§10), retests, RCA (§11), CAPA. Auto-closes when all requirements are met.
Only the assigned verifier from Setup → QA Verification Assignments can Verify or Reject (not the performer).
Sistema HACCP / Inocuidad Alimentaria. Se guarda en el registro central de CAPA (sharedCapaDeviationData / capa_records) y aparece en la app CAPA + Deviation.