Validated systems, serialized product and a plant floor kept apart from email

Pharmaceutical Manufacturing IT Services

In pharmaceutical manufacturing, the batch isn't done until the record is: every step, signature, deviation and test result has to be complete, attributable and protected, or the product can't be released.

Talk to Us About Pharmaceutical Manufacturing IT 888.792.8080

SOC 2 Aligned

Responsive Support

20+ Years Experience

At a glance

A ransomware hit or an uncontrolled infrastructure change can stop production and put validated status in question at the same time.

We run managed IT and cybersecurity for small and mid-sized drug manufacturers, contract manufacturers and packagers.

That includes qualified infrastructure for ERP, QMS, LIMS and MES, Part 11 supporting controls, serialization connectivity for DSCSA, and a hard boundary between business IT and plant-floor systems, coordinated with your automation engineers.

IT that keeps batches releasable, records defensible, the line running.

Managed IT for drug manufacturers where infrastructure changes need the same discipline as the process.

Pharma manufacturing IT

No record, no release. No exceptions.

Pharma plants run on validated systems and documented change. The ERP plans the batch, the MES or paper record guides the floor, LIMS holds QC results, the QMS tracks deviations and serialization ties every saleable unit to the supply chain. Here's what depends on IT, how it breaks and what we change.

01 · The pressure

From dispensing to release, every step recorded

Operators dispense raw materials against a batch record, equipment runs under control systems on the floor, QC tests samples in LIMS and quality reviews everything before release. Packaging lines print and aggregate serial numbers that flow to your serialization platform and trading partners. Any break, a down ERP, an unavailable LIMS, a serialization server that won't talk to the line, means product waits in quarantine and customers wait on orders.

Batch records tied to every step
QC results in LIMS gating release
Serialization data flowing to partners

02 · How it breaks

Flat networks and undocumented changes

Manufacturing networks often grew without a plan, so office PCs, packaging line controllers and lab instruments share one flat network. Ransomware that starts with a phished planner can reach the floor. Equipment vendors leave remote access tools running on line PCs. IT patches a server under a validated system without change control and creates a compliance question nobody planned for. And serialization connections fail quietly until a shipment can't be verified.

Office and plant floor on one flat network
Vendor remote tools left on line PCs
Infrastructure changes outside change control

03 · What we change

Zones, controlled change and qualified infrastructure

We separate business IT from the plant floor with a demilitarized zone, coordinating with your automation engineers on anything inside the control layer. Vendor access to line equipment goes through brokered, logged sessions. Infrastructure changes under validated systems follow your change control, with documentation your quality unit can use. Endpoints get managed detection and response with 24/7 SOC monitoring, and GxP data gets immutable, restore-tested backups.

IT/OT boundary with a managed DMZ
Infrastructure changes under change control
Immutable, restore-tested GxP backups

04 · The after

Inspections, customer audits and steady output

When an FDA investigator or a client's quality auditor asks how infrastructure is controlled, your team hands over qualification records, change logs and backup evidence. A phished laptop in purchasing stays a purchasing problem instead of a production stop. Serialization alerts arrive before a shipment is held. And when you add a line or a new client product, IT follows a documented process your quality team already trusts.

Qualification and change records on hand
Office incidents kept off the plant floor
Serialization issues flagged before shipment

Systems we keep running

SAP S/4HANA
MasterControl
Veeva Vault QMS
LabWare LIMS
TraceLink
Rockwell FactoryTalk
Siemens Opcenter

Rules we help you meet

21 CFR Parts 210 and 211 (CGMP)
21 CFR Part 11
Drug Supply Chain Security Act (DSCSA)

What We Offer

Comprehensive solutions tailored for Houston-area businesses

Qualified GxP Infrastructure

We build and operate the servers, storage, virtualization and networks under your ERP, QMS, LIMS and MES with installation and operational qualification documentation your quality unit can reference. Validation of the applications themselves stays with your team or validation partner; we make sure the foundation they sit on is controlled and documented.

IT/OT Boundary Protection

Business systems and plant-floor control systems belong in separate zones with tightly limited traffic between them. We design and run that boundary, including the DMZ that hosts historians or data exchange, and coordinate with your automation and controls engineers and equipment OEMs for anything inside the control layer.

Part 11 Supporting Controls

21 CFR Part 11 expects access controls, audit trails and secure electronic signatures for regulated electronic records. We provide the infrastructure pieces: directory and role design, MFA, time synchronization, protected logs, backup and documented account management, giving your validation team evidence to cite in system assessments.

Serialization & DSCSA Connectivity

Manufacturers must apply product identifiers and exchange transaction data with trading partners under DSCSA. We keep the servers, networks and integrations between packaging lines, your serialization platform and partner connections available and monitored, and alert on failed exchanges before they hold up a shipment. We also keep the line-side servers patched under change control.

Change Control for Infrastructure

Patching a server under a validated system is a change, and it needs to be treated like one. We follow your change control process for infrastructure: impact assessment, approval, execution records and verification, and we schedule work around production campaigns so maintenance never surprises the floor.

Vendor & Equipment Remote Access

Equipment OEMs, software vendors and integrators all need remote access at some point. We replace permanent remote tools with brokered sessions that require approval, record activity and expire automatically, so a vendor's compromised account doesn't become a path onto your packaging line. You get a full record of every vendor session for audits.

Why Choose LayerLogix?

Serving businesses throughout the Greater Houston area including Houston, Dallas, Austin, San Antonio, Atlanta, Nationwide.

Production Protected From Office Threats

A segmented boundary means a phished email in sales or purchasing doesn't put batch records and line controllers at risk. Incidents stay contained to the business network while the floor keeps running. Your plant manager hears about an office incident as a report, not as a line stoppage.

Infrastructure Your Quality Unit Trusts

Qualification records, change logs and documented account management give quality a clear story for inspections and client audits. Nobody has to reconstruct what IT did to a validated system last quarter. Change records for every server and network change sit in one place, ready to pull.

Fewer Held Shipments

Monitored serialization connectivity and reliable ERP and LIMS infrastructure mean product moves from release to shipment without IT-related delays. Failed partner exchanges get caught and fixed before a customer's receiving dock rejects the order. That keeps customers and distributors happier.

Better Answers for Clients and Insurers

Contract manufacturing clients and cyber insurers ask detailed questions about segmentation, backups and vendor access. Documented controls make those questionnaires faster and help you win and keep client programs. Insurers in particular respond better to evidence than to checkboxes on a renewal form.

Our Process

Walk the plant with operations, quality and automation leads to map business systems, GxP systems, line equipment and data flows.

Inventory servers, networks, endpoints, vendor connections and serialization integrations, noting which systems are validated and who owns them.

Design the IT/OT boundary with your controls engineers, then close vendor remote tools and urgent exposure in a scheduled window.

Bring infrastructure under your change control, produce qualification documentation and deploy endpoint detection on business and DMZ systems.

Set up immutable backups for GxP data with restore tests your quality unit witnesses, plus monitoring for serialization and core systems.

Review changes, alerts, vendor sessions and backups monthly and plan maintenance around production campaigns and validation schedules.

Frequently Asked Questions

Can you patch servers that run validated systems?▼

Yes, inside your change control process. Infrastructure patching is usually handled under a risk-based approach your quality unit approves: some updates go through a defined assessment and verification, others need more testing first. We document the impact assessment, approvals, execution and verification for each change, schedule work around production campaigns and provide records your validation team can reference. What we won't do is push changes to a validated environment outside that process.

Will you work on our PLCs, HMIs or packaging line controllers?▼

No. Control systems and line equipment belong to your automation engineers, integrators and OEMs, and changes there can affect validated processes and safety. We secure the IT side and the boundary: segmentation, the DMZ, remote access paths, the workstations and servers that interface with the floor, and monitoring at the network edge. We coordinate with your controls team on any change that touches their systems, so security work never surprises production.

How do you support 21 CFR Part 11?▼

Part 11 compliance is a property of the whole system, including software, procedures and people, and your quality unit owns that assessment. We cover the infrastructure controls it depends on: unique user accounts, role design, MFA, time synchronization across servers, protected audit logs, backup and recovery and documented account management. We deliver that as evidence your validation team can reference, rather than declaring any system Part 11 ready on our own say-so.

What does DSCSA mean for our IT systems?▼

The Drug Supply Chain Security Act requires manufacturers to put product identifiers on packages and exchange transaction information with trading partners electronically. That depends on line-level printing and aggregation, a serialization platform and connections to partners or a network service. Your regulatory and supply chain teams own the program. We keep the supporting servers, networks and integrations reliable and monitored, and alert on failed transmissions so they're fixed before shipments are held.

We are a contract manufacturer. Clients send long security questionnaires. Can you help?▼

Yes. Client questionnaires and quality agreements ask about segmentation, access control, data integrity, backups, vendor access and incident response. We help you document those controls accurately and keep the evidence current, so answers come from real configurations rather than aspirations. We can also join calls with client auditors to explain the infrastructure side. Commitments in quality agreements should still be reviewed by your quality and legal teams before you sign.

Can you support a plant outside your local area?▼

Yes. Most infrastructure and security work is remote, done by U.S.-based engineers with documented access to your environment. For on-site work like network cabling, rack installs or hardware replacement, we handle it locally near our offices or send a vetted local technician who works under our engineer's direction and follows your site's gowning and access rules. We support manufacturers in Texas and nationwide. Every site gets the same boundary design and change discipline, whoever does the hands-on work.

Ready to Get Started?

Contact LayerLogix today for a free consultation. We serve businesses throughout Houston, Dallas, Austin, and the surrounding Greater Houston area.

Schedule Free Consultation Call 888.792.8080