Custom
Electronics for the Labs, Plants, and Cold Chains That Advance Human
Health
From 21 CFR Part 11 compliant environmental monitoring and GAMP 5 validated bioreactor controllers to GDP cold chain loggers and PAT inline analyzers — Ankh Innovations engineers custom pharmaceutical electronics from schematic to FDA-ready validated product.
The Stakes in Pharmaceutical Electronics
A Single Audit Finding on Your Electronic Records System Can Halt an FDA Inspection and Delay a Drug Approval
Pharmaceutical electronics are not instruments that can be validated after the fact. FDA 21 CFR Part 11 and EU Annex 11 require that electronic records and electronic signatures be attributable, legible, contemporaneous, original, and accurate — the ALCOA+ principles — from the first production use of the system. A device that was not designed for Part 11 compliance from the ground up generates audit trails that don't satisfy FDA inspectors and data that doesn't support regulatory submissions.
GAMP 5 categorizes computerized systems by complexity and risk, requiring validation documentation proportional to the category. A custom hardware controller running embedded firmware is typically Category 3 (non-configurable software) or Category 5 (configurable software) — both require IQ, OQ, and PQ protocols, full traceability to URS requirements, and controlled change management for the product lifecycle.
Ankh Innovations engineers pharmaceutical electronics with Part 11-compliant audit trails, GAMP 5 lifecycle documentation, and IQ/OQ/PQ protocol templates that can be directly adapted to your site SOPs and submitted to your regulatory affairs team — not retrofitted after an FDA 483 observation.
From Cold Chain Loggers to Bioreactor Controllers
GDP Cold Chain Monitoring & Logging Hardware
PAT Inline & At-Line Analytical Instruments
Bioreactor & Fermentation Control Electronics
LIMS & EBR Integration Hardware
Clinical Trial Supply Chain Electronics
Cleanroom Environmental Monitoring Systems
Stability Chamber & Storage Monitoring
SIP/CIP & Clean Process Electronics
Installation Qualification, Operational Qualification, and Performance Qualification protocol development tailored to your site SOPs. Protocols are authored with pass/fail criteria, data tables, and signature blocks ready for direct insertion into your validation master plan.
Why Engineering Teams Choose Ankh
We Write the Audit Trail Into the Firmware Spec, Not the Corrective Action Report.
21 CFR Part 11 audit trail requirements are not a documentation overlay. They are a firmware architecture constraint — every write to a regulated record must capture operator identity, timestamp, reason for change, and the previous value. Systems that are not designed for this from the first sprint generate audit trail gaps that appear in FDA inspections as data integrity 483 observations. Ankh engineers Part 11 compliance into the state machine before a single line of application code is written.
We Write the IQ/OQ/PQ Protocols. Your Validation Team Reviews and Executes.
GAMP 5 documentation is frequently outsourced to validation consultants who write generic protocols against system descriptions they do not fully understand — producing test scripts that cover the easy paths and miss the edge cases that FDA inspectors find. Ankh engineers author URS, FS, DS, and IQ/OQ/PQ protocols in parallel with hardware and firmware development, so the test protocols reflect the actual system behavior and the traceability matrix connects every URS requirement to a verified test result.
PAT Is Not a Marketing Slide. We Integrate Spectrometers, Chemometric Models, and Real-Time Process Control.
Process Analytical Technology for pharmaceutical manufacturing requires more than a sensor and a USB interface. It requires NIR or Raman hardware with sufficient SNR for chemometric model performance, a data acquisition system that records raw spectra with Part 11 compliant metadata, and a process control integration that responds to model outputs in real time. Ankh designs PAT hardware from the optical bench through the process control interface, and our firmware team integrates PLS and PCA chemometric models directly into embedded control loops.
Your Regulatory Affairs Team Gets a Validation Package, Not a Binder of Raw Test Data.
The end deliverable of a pharmaceutical electronics program is not working hardware — it is a submission-ready validation package: GAMP 5 system overview, IOPQ reports with protocol deviation notes, Part 11 compliance matrix, calibration certificates, and change control procedures. Ankh builds the regulatory documentation package as a project deliverable with the same rigor we apply to hardware design, so your RA team can submit to FDA or EMA without spending months translating engineering artifacts into regulatory language.
Part 11 Compliant Cold Chain Platform for Global Biologics Distribution
A global biologics manufacturer needed a 21 CFR Part 11 compliant cold chain monitoring platform covering 340 warehouse locations across 28 countries, with a unified audit trail and automated MKT excursion assessment. Ankh designed the data logger hardware, cellular and Ethernet communication modules, and cloud-connected data repository — achieving FDA audit-ready compliance and reducing temperature excursion-related product loss by 38% in the first year.
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