Industry · Biotech & pharma
Security the FDA and DEA inspector both sign off on.
Tec-Tel designs, installs, and runs zoned access, controlled-substance vaults, and IP-protection coverage for biotech, pharma, and life-sciences facilities. Aligned to 21 CFR Part 11, DEA, and GMP.
- NDAA-compliant
- Platform-agnostic
- 1,000+ deployments over 15 years
§01 What we install in life sciences
An audit trail that holds up when the inspector pulls it.
What a facility gets once Tec-Tel commissions the system, and what your QA director, facilities lead, and FDA inspector see from day one.
§ How we work
When an FDA inspection flags the controlled-substance audit trail, the fix is the vault. We rebuild access with a two-person rule and Part 11-aligned logs so the physical-security records hold up the next time an inspector pulls them.
How Tec-Tel works in life sciences
§02 How a Tec-Tel deployment works
Five steps, one accountable team.
Walk every zone before we quote
No quote-by-floorplan. We come on site, talk to your facilities, QA, and security leads, and document all four clearance zones.
Design to FDA + DEA from day one
21 CFR Part 11 audit-trail integrity, DEA controlled-substance handling, GMP-compliant hardware. Designed to the inspection, not retrofitted.
Segment from lab + production networks
Physical-security network segmented from LIMS, MES, and production. QA and IT both want the separation documented.
Commission around validated environments
GMP suites cannot be disrupted casually. We sequence install around change-control and re-validation windows.
Hand off with an inspection packet
Your team gets a written ops doc plus an FDA + DEA inspection-ready package. Every zone, every retention rule, every audit-trail control mapped.
§03 How we deploy
Three facility types. Three tailored builds.
An R&D campus, a GMP manufacturing suite, and a multi-site operation each draw the controlled zones differently. Here's how the three break down.
Biotech R&D, IP-heavy, pre-commercial
- → Zoned access from general office to BSL labs
- → Sample-freezer + data-room IP-protection coverage
- → Visitor management with NDA + escort workflow
- → Audit trail aligned to your IP-security program
Commercial pharma or biologics manufacturing
- → GMP clean-room compliant cameras + readers
- → Controlled-substance vault with two-person rule
- → 21 CFR Part 11 audit-trail integrity
- → Install sequenced around validated-environment change control
Life-sciences company across R&D + manufacturing sites
- → Standardized zoned-access spec across sites
- → Central VMS with role-based per-site + per-zone access
- → NDAA Section 889-compliant (federal research funding)
- → Unified inspection-documentation package
§04 Compliance buyers ask us about
Frameworks we build to.
Electronic-records and audit-trail integrity. Access events with tamper-evident logs, attributable to an individual, retained for the inspection window.
Controlled-substance handling: two-person rule on the schedule-drug vault, camera on the cabinet, badge-plus-PIN audit trail tied to the DEA registrant.
Good Manufacturing Practice. Clean-room and wash-down compliant hardware, install sequenced around validated environments and change control.
Companies with federal research grants or contracts hit Section 889. NDAA-compliant cameras + switches, documented BOM.
Questions buyers ask us
FAQ
- How does a biotech facility security install work?
- Four clearance zones: general office, lab, GMP suite, and controlled-substance storage. Each zone gets its own credential, camera, and audit log. We design the whole stack to FDA 21 CFR Part 11 and DEA controlled-substance requirements, use GMP-compliant hardware, and sequence install around validated-environment change control.
- Does this satisfy FDA 21 CFR Part 11?
- Yes by design. Part 11 requires electronic-record and audit-trail integrity: access events attributable to an individual, tamper-evident, and retained for the inspection window. We design and document access control and camera systems to that bar and provide an inspection-ready package.
- How do you handle controlled-substance storage?
- DEA Part 1300 expectations: two-person rule on the schedule-drug vault door, camera coverage of the cabinet, and a badge-plus-PIN audit trail tied to the DEA registrant. Full chain-of-custody from door to cabinet to timestamp.
- Will the install disrupt our validated GMP environments?
- No. GMP suites cannot be disrupted casually, and we design for that. Install sequences around change-control and re-validation windows, hardware is clean-room and wash-down compliant, and we coordinate with QA before touching a validated space.
- How do you protect our IP?
- Coverage of R&D labs, sample freezers, and data rooms documents who accessed what, when. Both a deterrent and the record if IP theft is ever investigated. Access ties to AD or Azure AD, and visitor management enforces an NDA-and-escort workflow.
Book a free assessment
Tell us about your facility.
Get on a call with the Tec-Tel team. We'll walk through what 21 CFR Part 11 and DEA expect, what your zones need, and what a defensible budget looks like.
- Tell us how many sites you run and what's already in place. We'll show you what a build or upgrade looks like.
- Straight answers from the team that does the work. We're platform-agnostic, so you get the system that fits your sites, not one brand's catalog.
Since 2010 · 1,000+ deployments nationwide · ISN-accredited
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How can we help?
What you're looking for, plus any details. We review it and follow up, usually the same day.
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