Life Sciences
Would your lab or plant still ship with sign-in down? We supply and integrate the network and servers, and check that first.
Request a quoteLife Sciences
Would your lab or plant still ship with sign-in down? We supply and integrate the network and servers, and check that first.
Request a quoteOrder processing, manufacturing, shipping: disrupted together.⁸
The cases on this page are public record, not our clients. Stryker’s filings describe a March 2026 cyber incident it called material to operations. Manufacturing and ordering were later restored.⁸ The filings do not say what failed.
We write into your requirement: we still ship with office systems and sign-in down.
We check which plant, order and shipping steps need that sign-in. Validated servers on Windows Server 2016? Support ends January 12, 2027.¹⁰ We supply and integrate the replacement.
What buyers need.
What you will be asked to show, and the design that answers each.
Automation log.
Actor, target, time, change and result for every automated action.²
Write-once archive.
Control-plane logs kept at least 400 days.²
Traceability.
Each requirement traces to one need and one verification method.²
Access.
Identity disabled means access lost within 5 minutes.²
Backups.
No data lost inside a pod; 15 minutes to the other pod.²
Lifecycle records.
A handover pack with as-builts, serials, configurations and signed test results.
Quality record.
One staging record per unit.²
A vendor’s calibration deleted the data. No backup existed.⁹
The FDA’s warning letter to Fareva Amboise, April 10, 2026. We check who can change a date, a limit or a record on each system, and where its backup sits.
The rules.
We write into your requirement: nobody, vendor included, changes a production record unlogged, and every record has a backup. Each rule, with its version.¹
Applies to.
Electronic records and electronic signatures.
Our coverage.
Every automated action logged where the actor cannot alter it, kept 13 months.²
Covered by.
Applies to.
Automatic, mechanical and electronic equipment.
Our coverage.
Full.²
Version in force.
Jul 2022.
Our coverage.
Partial.²
Version in force.
2011 revision; the 2025 revision draft is not final.
Our coverage.
Partial: an audit trail of changes to GMP data and systems, and archived GMP records.²
Covered by.
Your questions, answered by engineers.
Validation questions.
Each answer points to the requirement behind it.²
Deviations signed.
Each deviation from the build sheet and firmware baseline carries a signed change order.²
What is logged.
Actor, target, time, change and result, kept 13 months as a design assumption.²
Traceability.
Under ISO/IEC/IEEE 29148.²
We supply Dell, NetApp, NVIDIA and Veeam: servers, storage, GPUs and backup.
How we choose what to quote: four questions.
1. Does it answer the need? Anything that does not is set aside here, not ranked lower later. 2. Does it meet every line? Assessed against the stated criteria only. Options are never scored against each other. 3. What does it cost? Weighed only among options that met every line. Cost never rescues an option that failed the requirement. 4. Can it arrive by your date? Lead time, stock and supply: whether the recommendation can actually be delivered.
Who wrote these designs.
Principal architects Mark Winston, Steve Phillips, David Morgan, Avinash Dhinakaran and Diksha Shah.
Who wrote these designs.
Principal architects Mark Winston, Steve Phillips, David Morgan, Avinash Dhinakaran and Diksha Shah.
Automation Blueprint
Every change reviewed, model-checked and reversible.³
Automation Blueprint
Every change reviewed, model-checked and reversible.³
4,000 staff.
Signed in without passwords within 12 months, on FIDO2 keys.⁵
32 GPUs.
A pharma research cluster, with 2 PB of flash.⁶
15 minutes.
The most GxP data lost if a drug maker's primary cloud region fails.⁷
Design studies
Design studies in this sector
Talk to an expert about your requirement.
Send what you need to buy and by when. You get a reply the same day, then a quote.⁴
Talk to an expert about your requirement.