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By: PTC     Published Date: Aug 21, 2009
In February 2004, the FDA issued a Draft Guidance requiring the electronic submission of labeling content to be provided in an XML-based format called Structured Product Labeling (SPL). The purpose of this white paper is for the reader to gain an understanding and prepare for the FDA's new electronic labeling submission standard.
Tags : best practices, enterprise software, product lifecycle management, plm, product information, product information management, pim, catalog
     PTC
By: ProofSpace     Published Date: Aug 07, 2007
This white paper presents a solution framework for Life Science Organizations that want to implement enterprise digital trust management to protect their electronic value chain.
Tags : proofspace, proofmark, signing key vulnerability, trustworthy time, authenticated time stamps, time existence of data, electronic postmark, time stamp
     ProofSpace
By: ProofSpace     Published Date: Aug 17, 2007
This white paper defines the life cycle of an electronically signed record and describes  the requirements for handwritten signature-equivalence throughout its retention period.
Tags : proofspace, proofmark, signing key vulnerability, trustworthy time, authenticated time stamps, time existence of data, electronic postmark, asymmetric key cryptography
     ProofSpace
By: ProofSpace     Published Date: Sep 10, 2007
Read this paper and learn the principles that are prerequisites to enforceable electronic agreements as required by existing legal standards and electronic signature legislation.  This paper will also specify sixteen measurement criteria that can be used as metrics to assess whether the architecture of an electronic transaction will meet the requirements of admissibility.
Tags : proofspace, proofmark, signing key vulnerability, trustworthy time, authenticated time stamps, time existence of data, electronic postmark, asymmetric key cryptography
     ProofSpace
By: Ecora Software     Published Date: Aug 15, 2007
21 CFR Part 11 continues to cause confusion. Recent FDA guidance documents help, but many IT departments still struggle to establish appropriate validation processes with limited time and resources. Ecora's FREE in-depth guide, "Achieving Sustainable IT Compliance to 21 CFR Part 11," gives you an overview of the regulation from an IT perspective. It also outlines how you can accurately and cost-effectively implement a systems-based best practices approach that will help you meet FDA requirements.
Tags : 21 cfr part 11, compliance, electronic records, electronic data, electronic signatures, information management, pharm, pharmaceuticals
     Ecora Software
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