Sectors · Pharma
Pharma & life sciences
Valuable intellectual property, regulated data integrity and complex supply chains put pharma and life sciences under sustained, sophisticated attack.
Last reviewed . Regulation moves, so check the regulation tracker for the current position.
The pressure
IP worth stealing, records that must hold.
Pharma and life sciences carry two burdens at once. Research, formulation and process IP is a target for patient, well-resourced actors. At the same time, the records that demonstrate a product is safe have to be trustworthy by regulation. The MHRA’s GxP data integrity guidance sets that expectation, and the ALCOA+ principles describe it: data that is attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available.
For computerised systems that means validated systems, controlled access and audit trails nobody can quietly edit: EU GMP Annex 11 where you manufacture for the EU, FDA 21 CFR Part 11 where you supply the US market, and GAMP 5 as the risk-based approach to validating the systems themselves. Security controls have to be introduced without undermining any of it, which is why bolting on a tool rarely survives an inspection.
Challenges we hear
The pressures specific to pharma and life sciences.
- Protecting research, formulation and process IP from patient, well-resourced attackers
- Keeping audit trails, user access and electronic signatures defensible under inspection
- Adding security controls to validated systems without triggering unnecessary revalidation
- Laboratory and manufacturing equipment running operating systems that are no longer supported
- CRO, CDMO and supplier access into your data, your systems and your sites
- Clinical and trial data, which is special-category personal data under UK GDPR
- Answering partner, licensor and investor security due diligence during a deal
Rules that apply
The obligations and standards in play.
- MHRA GxP data integrity guidance, and the ALCOA+ principles behind it
- EU GMP Annex 11 for computerised systems, where you manufacture for the EU market
- FDA 21 CFR Part 11 for electronic records and signatures, where you supply the US market
- GAMP 5 as the risk-based approach to validating computerised systems
- ISO 27001 for the management system, increasingly a partner and licensor requirement
- UK GDPR, including special-category clinical and trial data
Related
Where to start
Four steps that serve security and data integrity alike.
- End shared logins on GxP systems so every action is attributable
- Agree a risk-based route for patching validated systems through change control
- Segment laboratory and manufacturing systems that cannot be patched
- Review CRO, CDMO and supplier access into your data and sites
How we help
Protection and proof, joined up.
- Layered identity, endpoint and data controls around research and process IP
- Access governance and audit-trail protection that stands up in a GxP inspection
- Segmentation for laboratory and manufacturing systems that cannot be patched
- Supply-chain and third-party risk management across CROs, CDMOs and distributors
- ISO 27001 kept audit-ready, and 24×7 detection across a complex, multi-site estate
Where to start
FAQ
Questions buyers actually ask
How do security and quality agree a patching route?
Agree it once rather than patch by patch: a documented, risk-based procedure that sorts patches into classes, such as routine operating-system updates on a configured system versus changes to validated application code, sets the testing each class needs, and runs through normal change control. Quality approves the procedure; security works within it.What do partners and CROs ask a pharma company to evidence?
Typically ISO 27001 or an equivalent control framework, access control over shared data and systems, how third-party access is granted and removed, incident notification commitments, and how data integrity is protected in the systems that hold shared records.What should we do about lab instruments on unsupported operating systems?
Isolate them: put instruments on their own network segment, allow only the connections they need, typically to the data system that collects their results, disable internet access and removable media where possible, and monitor the segment. Then plan replacement into the equipment lifecycle.Can we use cloud services for GxP data?
Yes, provided the infrastructure is qualified and the system validated for its intended use, and your supplier assessment, contract and controls cover data integrity: audit trails, access, backup, and your ability to retrieve complete records for inspection. Responsibility for the data stays with you.How do we protect research IP from targeted attacks?
Know where it is, limit who can reach it, and watch for it leaving. Classify research and process data, restrict access to named people, enforce multi-factor authentication and managed devices, and monitor for unusual access or bulk downloads. Review access whenever projects, partners or people change.
Protecting valuable research?
Let’s talk about securing your IP, your data integrity and your supply chain.
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