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Needs Assessment The Food and Drug Administration (FDA) requires that all biotechnology companies produce and maintain detailed records of every test, process, and procedure involved in researching, developing, manufacturing, and marketing products. FibroGen needed to ensure that all its regulated clinical processes and procedures were documented and in full regulatory compliance.
Standard Operating Procedures for Amtrak
Amtrak's New York Division operates seven tunnels in New York City. The company needed a comprehensive, easy-to-use manual that employees could use to ensure worker safety and uninterrupted service.
HIPAA Privacy Expert for the California Department of Health Services
The Health Insurance Portability and Accountability Act (HIPAA) implements security procedures to ensure the confidentiality of health information and data. To be in compliance with HIPAA laws, the California Department of Health Services needed a Business Analyst and Technical Writer to prepare internal feasibility study reports.
Controlled Documents for SAP R/5 Global Implementation
Amgen’s SAP global implementation program required Controlled Documents used in association with critical business functions to ensure compliance with US and international regulations as well as company standards. The documents spanned work streams including Supply Management, Human Capital Management, and SAP IT Operations.
Standard Operating Procedures
As part of its global ERP implementation (SAP R/5) Amgen needed to document a wide variety of global processes. This required a background in specific areas of the enterprise, as well as expertise in working within a federally-regulated environment.
Policies & Procedures
Wells Fargo Bank maintains and services a wide variety of internal computer systems and applications. In order to support and maximize these systems, as well as protect the integrity of data, the bank needed to develop usable, comprehensive, detailed security standards for these systems.
Online Help Project
Gap, Inc. wanted detailed, context-sensitive online help available for all screens and functions to provide instant assistance to employees with questions when they were rolling out their new automated store inventory system. This needed to be completed simultaneously with completion of the application.
Software Documentation
The Informix environment changes rapidly. Informix needed technical writers to document the 2000 releases for Informix 4GL database products. The writers had to research software changes and include all new features. They also had to highlight major changes since the previous release.
ISO 2000
Sierra Mountain Express needed assistance in defining requirements and metrics to become ISO 2000-certified. They had no internal resources to draw upon to tackle this mission, so they turned to TechProse for assistance.
SAP ProceduresWork Instructions
The Abgenix SAP implementation affected hundreds of employees at all levels of the company. Specific job functions were changing, and Abgenix needed to develop SAP work instructions for hundreds of procedures. These procedures needed to be compliant with federal regulations for each job function. In addition, Abgenix wanted to develop a compatible series of SAP e-learning modules to supplement these procedures.
White Papers
Alcatel had a number of innovative products including Bluetooth and Broadframe, but no white papers or professional documentation to adequately describe the technology and its features.
Training and Documentation
Southern Wine and Spirits of America, Inc. (Southern), is a nationally recognized wine and spirits distributor. Southern’s new Business-to-Business (B2B) application gave its customers the ability to place orders online, and the company needed to train its national sales force on the new application. Southern also needed a User Guide for customer reference, and a Conditions of Use document that outlined the company’s liability.
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