Ransomware protection that keeps validated systems running and gives your quality team the proof inspectors ask for.
Ransomware in pharma puts more than systems at risk. It can reach validated production, batch records and the research behind every product, and an attack on a GxP system quickly becomes a data integrity question for your quality team. Helm contains ransomware at the data layer, verifies that systems are clean before they come back and keeps the record your inspectors expect.
Pharma progress lives in two places. Production runs on validated systems, and the research and intellectual property behind each product sit on file shares and servers. Ransomware can reach both.
Pharmaceutical manufacturing shares the risks of manufacturing as a whole. In Verizon’s 2026 Data Breach Investigations Report, ransomware was present in 61% of confirmed breaches in manufacturing.
For a pharma company, encryption on a GxP system is also a data integrity question. Electronic records have to stay complete, accurate and retrievable throughout their life, under FDA 21 CFR Part 11 in the United States and MHRA’s GxP data integrity guidance in the UK. Bringing systems back is only half the job. Your quality team also has to show that the data can be trusted.
61%
of confirmed breaches in manufacturing had ransomware present (Verizon 2026 DBIR).
EU GMP Annex 11 asks for regular backups, with their integrity and the ability to restore them checked, and for continuity arrangements for computerised systems that support critical processes. MHRA’s guidance goes further, asking for backup and recovery processes that are validated and periodically tested, with each backup verified.
In the EU, NIS2 adds a further layer. Manufacturers of pharmaceutical products are listed in its health sector, with incident reporting deadlines of their own. Our NIS2 overview explains what that means in practice.
The common thread is proof. Inspectors want to see that systems came back in their validated state, and that the data behind every batch and study can be trusted.
Helm works at the data layer, on the file servers and shares where ransomware does its damage. Detection combines independent sensors on file activity, and containment runs on fixed rules your team can read and explain to an inspector. Helm detects active encryption in under a second and contains the attack on the rules your team sets, with no AI involved in containment.
Helm works beside your validated applications, on the file servers and shares, rather than inside them. Containment isolates the compromised accounts and devices behind the attack, so the lines, labs and systems that are not affected keep running.
Many plants run systems that cannot be patched without re-validation. Helm adds a containment layer around them and works alongside the security tools you already have.
Recovery is not done until it is proven safe. Helm verifies that systems are clean before they come back, so batch records and research data are restored from a known good state, not from the middle of the attack.
Every detection, containment action and recovery check is logged as it happens, with a timestamp. That record supports your deviation and CAPA process, gives Regulatory Affairs the facts for any notification, and shows an inspector how the incident was handled.
Proven clean before it comes back.
Systems are verified before recovery, so batch records and research data return from a known good state.
Ransomware will keep targeting the systems pharma depends on. Control means the attack is contained in seconds, unaffected lines and labs keep working, and systems come back only once they are verified clean.
Your quality team gets a record it can stand behind, and your business keeps production and research on track. To see what this looks like in your environment, talk to us.
