FDA
RSS FDATripwire and 21 CFR Part 11: Ensuring Integrity and Trustworthiness of Electronic Clinical Data
White Paper Food and Drug Administration (FDA) has issued a set of regulations, collectively called 21 CFR Part 111 and commonly referred to as Part 11, that provide criteria for acceptance of electronic records and electronic... [05 Oct 2009]
Digital Signatures for the Pharmaceutical Industry
White Paper Typical examples of digital signature use within the pharmaceutical industry include systems and processes such as electronic submissions, RA/QA, Standard Operating Procedures (SOPs), clinical operations, manufacturing instructions,... [02 Oct 2009]
CoSign for 21 CFR Part 11 Compliance
White Paper Company XYZ operates in a regulated environment and is subject to compliance with numerous US government regulations governed by the Food & Drug Administration (FDA) and HIPAA. This paper is provided to explain the use... [02 Oct 2009]
Partner Wins New ERP Business With Valuable Help From Technical Sales Assistance Team
White Paper Food and Drug Administration (FDA) to approve the operation. Abakion called on Technical Sales Assistance, a Microsoft Partner Program benefit, to gather the support required to convince its customer to use Microsoft... [01 Oct 2009]
Lilly and SAS: A 30-Year Relationship
White Paper The challenge was to accelerate the drug-development process to get products to patients faster while ensuring that FDA standards are met every step of the way. At Eli Lilly and Company, the success of its innovative... [19 Sep 2009]
Sanofi-Aventis Brings Products to Market More Rapidly With SAS
White Paper Sanofi-Aventis deployed SAS solutions that helped to speed development and streamline delivery of data to health to the FDA and other health authorities. "Because Health Matters. That's the slogan of the second largest... [19 Sep 2009]
HP Workstations Power Leading-Edge Neurosurgery Systems
White Paper This resulted in highly stable platform reduces risk of equipment failure during a procedure and backward compatibility of hardware facilitates continuing FDA compliance. Integra NeuroSciences wanted to provide robust,... [28 Aug 2009]
Accounting and Manufacturing Solution Eases Compliance for Antimicrobial Manufacturer
White Paper Food and Drug Administration (FDA), the U.S. Rapid financial reporting helps the company meet SEC deadlines for accelerated filings and improves traceability assists in meeting the compliance standards of the... [25 Jul 2009]
Cost-Effective Compliance With FDA Regulations for Your SAP Applications
White Paper As most companies sell to a global market they have to manage compliance with an increasing set of regulations around the world - most importantly the FDA regulations, such as FDA 21 CFR Part 11, if the... [18 Jul 2009]
Food and Drug Administration and the Google Search Appliance
White Paper The FDA is a scientific, regulatory and public health agency that works to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, U.S.food supply, and cosmetics. [22 Jun 2009]
Results and Lessons From the CDISC SDTM/ADaM Pilot Project
White Paper The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated... [02 Jun 2009]
Data Collection (Case Report Form) Standards: What You Need to Know About CDASH
White Paper The CDISC-led Clinical Data Acquisition Standards Harmonization (CDASH) initiative is a response to the FDA Critical Path Initiative. A Gartner business case for standards has identified the benefit of applying data... [02 Jun 2009]
Epicor Software Case Study: Synovis Interventional Solutions
White Paper Between the financial requirements of a publicly traded company and the FDA regulations of a medical products manufacturer, Synovis must be able to track and document virtually all its processes and products in... [30 May 2009]
Mapping CDISC Metadata Attributes: Using Data _Null_ and Proc Datasets in SAS
White Paper In the pharmaceutical environment, the CDISC Study Data Tabulation Model (SDTM) provides the framework for how clinical data should be submitted to the regulatory authority, such as the US Food and Drug Administration... [30 May 2009]
The Second CDISC Pilot Project: A Metastandard for Integrating Databases
White Paper The first CDISC SDTM/ADaM pilot project created a test submission of one study to the FDA using CDISC data and metadata standards, in order to test that these standards meet FDA requirements (described... [29 May 2009]
