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electronic record




FDA electronic record


FDA 21CFR 11 compliance


electronic document


FDA software


electronics engineering


Food and Drug Administration


Electronic Record Experts

The following experts are available as electronic record consultants and electronic record expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Electronic Record - A record that is produced and/or stored electronically, such as by a computer. One type of electronic record is a graphical record of a varying quantity, such as an oscilloscope output.

Synonyms:  electronic file

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Expert in Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records management; document management; electronic records. For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and ... See full profile

New York (NY), USA

Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Electronics and Power Conversion Design, Root Cause Analysis, Nuclear NEMP and EMP Protection.
Expert has applied leadership in the electronic design industry since 1988. Designing electronics and power conversion, (AC/DC and DC/DC) for military and commercial industries, specializing in the power conversion and electronic architecture industries. See full profile

United Kingdom

Expert in Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs
Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. See full profile

California (CA), USA

Expert in Biotechnology
Expert has practiced biotechnology since 1973. He has worked primarily in the development and troubleshooting of manufacturing processes and immunoassays. He has developed reagents for 21 analytes ranging from large proteins and ... See full profile

Pennsylvania (PA), USA

Expert in Power Electronics, solar inverters, induction motor drives, UPS
Expert has extensive knowledge of power electronics systems, designs and implementation. He excels in designs and development of high power converters, multi-level inverters, induction motor drives. He also has worked on UPS systems of rating ranging from ... See full profile


Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), USA


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