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J.E. Lincoln and Associates
P.O. Box 154
Tooele, UT 84074-0154
Tel: 888/882-4655
Fax: 435/882-4669
E-mail: jel@trilobyte.net
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Description:
Offers consulting services in QSR/CGMPs, 21 CFR Part 820, 21 CFR Parts 210, 211, and 11 (electronic records and signatures), ISO 13485:2003, ISO 14971:2007 (hazard analysis and risk management), project management, product/process engineering, validations (including software), statistical analysis, and domestic and international regulatory submissions. This includes training, documentation, data analysis/trending, SPC, QMSs, SOPs, work instructions, specification (product and component), protocol and proposal development, and technical writing. Short- and long-term assignments are accepted.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Market Research Services (31 companies)
- Consulting Services: Packaging, Labeling Services (34 companies)
- Consulting Services: Process Development and Validation (62 companies)
- Consulting Services: Product Testing (68 companies)
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (74 companies)
- Consulting Services: Site Selection, Facility Design (9 companies)
