GMP Manufacturing Support – Electronic Repair Service – Reliability Engineering
Unidec specializes in extending end-of life support of industrial automation controls and equipment utilized in electronics manufacturing, pharmaceutical production and other commercial industries. Need a replacement part or service? We can help.
Test and Measurement
- Support of pharmaceutical processing
- Validated process control repairs and support
- Validated process monitoring system support
- GMP equipment life-cycle extension
- IQ, OQ and PQ validation support
- RCFA Failure analysis and guidance
- CAPA SOPs and guidance
- GMP and GAMP compliance
- ORA-LAB 5.5 Compliance
|John Fisher has presented at the International Society of Pharmaceutical Engineers (ISPE) on “Reducing cGMP Equipment Downtime and Related Drug Shortages”and “Extending the Life-Cycle of cGMP Manufacturing Equipment”|
Unidec provides support of cGMP validated equipment utilized in the pharmaceutical industry. We specialize in extending the lifecycle of validated equipment well beyond the typical OEM support cycle. We help keep you GAMP compliant and offer a host of reliability engineering services including root cause failure analysis (RCFA) and corrective action preventative action (CAPA) support to help you extend the life and improve the performance of your machines.
Unidec was founded in 1989 by John Fisher to satisfy a pent-up demand for electronics repair of industrial automation electronics. Unidec answered part of the repair need by quickly becoming a valuable supplier to over two hundred electronics manufacturers in a period of just three years. In the same period, Unidec developed repair for over three hundred (300+) electronic assemblies employed in the majority of through-hole and SMT equipment produced by OEMs. While Unidec initially provided services direct to electronics manufacturers, Unidec also offered repair services direct to the OEMs. For example, Unidec helped both Philips and Fuji initially support their North American clients by becoming their primary repair source for the majority of the electronics used on their equipment. Unidec continues today with support agreements to equipment makers and third-party firms to help service and source key-products. Unidec currently supports over 2,800 industrial and commercial electronic controls and systems.
Unidec over the past ten years has created and leveraged a new technology which combines functional test with traditional ICT to solve a two decade long problem facing test and repair of circuit boards. Unidec’s Tacit Expert System leverages rapid test development (RTD) software libraries to create deterministic functional diagnostic tests. In other words, functional test software that is re-usable between various products.
Our Tacit ES system leverages ICT vector capture and compare heuristics to find subtle circuit failures other ICT equipment often miss, This proprietary Tacit-ES technology is similar to today’s antivirus software that looks for patterns of data (heuristics) that are incorrect during a board’s function. Then, the combination of knowledge base information and expert knowledge learned in the process helps determine which device is causing a functional test to fail. This proprietary technology is designed to take the guesswork out of circuit board test and troubleshooting. The technology also improves quality and dramatically reduces the likelihood of faulty circuit boards from being put back into service.
Unidec’s excels at built-in-self-test (U-BIST) is part of any comprehensive functional test methodology. Unidec has decades of experience in developing diagnostic utilities that are designed to run on the target processor of an embedded system. We designed our BIST diagnostics to test a board or systems functionality and full processor speed which helps ensure that the unit will be fully functional when installed in the field. Unidec will develop BIST diagnostics in addition to other functional and in circuit testing whenever possible.
See our entire repair catalog image library here