Pharma OT security monitoring

A pharmaceutical or life sciences site runs on controlled, validated systems. Process equipment is automated by PLCs and supervised through SCADA. Batch execution systems generate batch records. Cleanroom HVAC and the building management system hold pressure, temperature and humidity where the process requires.

These systems are validated. Changing them triggers review, documentation and sometimes revalidation. That makes GMP manufacturing OT security a different job from securing an office network.

In a plant under change control, an agent installed on a controller or a scan that touches a validated device is a problem. Passive OT visibility exists for this reason. It watches network traffic without changing the systems.

ForgeSOC works the same way. Our analysts get read-only, least-privilege access to the platform you already own. They never write to a controller or workstation, and they do not push configuration. Nothing in our work should generate a change record on your validated systems.

• No agents or software on validated equipment.
• No configuration changes from our side.
• Sessions logged and recorded, with MFA on every account.
• Access through your secure remote access platform or hardened jump host.

Your concerns include the integrity of batch records and the availability of the process. You work under frameworks such as FDA expectations for data integrity and GMP, and likely ISA/IEC 62443 or NIST CSF in your security program. We do not claim ForgeSOC is compliant with or certified against any of them.

What we do is keep an informed set of eyes on your OT network. An unexpected connection to a batch execution server or an engineering workstation reaching a controller outside an approved window is something your quality and security teams want to know about quickly.

We do not deploy or administer your platform, run forensics or perform incident response. Any response touches validated systems, so those decisions stay with your teams, who know the change control process. We can connect you with response partners.

Security monitoring at a regulated site involves more than the security team. During onboarding we expect your quality and validation owners to review how access is set up and what the service touches. The answer should be short: read-only access to a platform that watches the network passively.

We then review the platform, map escalation contacts and write runbooks that name who to tell and in what order. A finding on a cleanroom BMS segment may involve facilities and quality together. We build that into the contact tree, review the baseline of current alerts, and run a test escalation before live monitoring begins.

Our monthly reports give you a record of what was alerted, what was triaged and what was escalated, which your teams can use alongside their own documentation.