Life is a Journey..how to make the best of it!

BayBiotech.NET Two ISO documents recently published provide harmonized principles and guidelines for the security of electronic health records. ISO/TS 21547:2010, Health informatics – Security requirements for archiving of electronic health records – Principles covers the basic principles needed to securely preserve health records in any format for the long-term. In the document, a holistic process covering records maintenance, retention, disclosure and eventual destruction has been extensively covered. Additional guidance for implementing ISO/TS 21547 is included in technical report ISO/TR 21548:2010, Health informatics – Security requirements for archiving of electronic health records – Guidelines. This report provides complementary guidelines to ISO/TS 21547, as well as a practical method and tools for the development and management of eArchives. Main features include the retention and records maintenance for a patient for entire lifespan reaching to 100+ years regardless o

BayBiotech.NET Standard Operating Procedures (SOP) are valuable tool that go beyond the basic procedural description of materials and methods and provide details about the appropriate precautions. A well written SOP is always a binding document in a regulatory environment and defines the details of the procedure to be followed across the board within an organization to perform a specific procedure. A well written SOP for a particular procedure should evolve with time after repeating the process under Research and Development Unit by testing the feasibility of the steps that makes it an easy to follow methods and minimizes the risks for Out of Specification reporting later on. A well evolved SOP has its origin from a simple stepwise flow chart of a complete process. If any changes are made in the process the SOP version in use must be updated by approval of the appropriate authorities and must be brought in use and supersede any other previous versions. A typical SOP contains the

BayBiotech.NET Through the ICH process (ICH M4Q), considerable harmonization has been achieved among the three regions (Japan, EU and US) in the technical requirements for the registration of pharmaceuticals for human use. To avoid the need to generate and compile different registration dossiers, the ICH: M4 guideline describes a format for the Common Technical Document that will be acceptable in all three regions. In a nutshell, CTD is an internationally agreed upon format for the preparation of a presentation for applications to be submitted to the regulatory authorities. However, the CTD does not address the content of submissions. There are many regional requirements, as well as applicants’ preferences, that could affect the contents of dossiers submitted in each region. According to the ICH guidelines, a document is defined for a paper submission as a set of pages, numbered sequentially and divided from other documents by a tab and a document can be equated to a file for a

BayBiotech.NET ISO 22000 is a food safety management system standard that defines a set of general food safety requirements that apply to all organizations involved directly or indirectly in the food chain. ISO 22000 requires establishing a food safety management system (FSMS) to ensure that food products do not cause adverse human health effects. ISO 22000 is designed to be used for certification (registration) purposes. However, the certification is not required. This includes every step from initial production to final consumption. More precisely, it includes the production, processing, distribution, storage, and handling of all food and food ingredients. Main objectives of ISO 22000 is to plan, implement and establish a food safety management system in order to ensure that products do not cause adverse health effects by demonstrating compliance with legal safety requirements. ISO 22000 uses almost the same basic structure as the ISO 9001 hence the organizations that have imple

BayBiotech.NET Conducting clinical trials in developing countries usually are faced with several local challenges and one of them is lack of local Institutional Review Board (IRBs) to review the informed consents and study protocols as well as monitor the study. Mostly, if a clinical trial is initiated outside US, the IRB within United States guides the trial. Mostly, in developing countries maintaining an efficient IRB is considered an extra financial burden on the system. Thus, a US sponsor in a developing country may face the challenges as the views on the judgment about risks and benefits of a trial may differ between the countries. In addition, developing informed consents become a main barrier due to a low literacy rate. Thus, the best solution to this could be that two IRB committees oversee the work, one based in United States as well as one in the developing country. The US sponsor must ensure the existence of such an IRB in the country of interest. The IRB in the country of

BayBiotech.NET Hello All, Here is a list of some resources related to Clinical Research and Regulatory Affairs, hope you will find them useful for your work! More to follow in my next blog…. Useful Resources 1. Directory of pharmaceutical industry-funded clinical trials, free and easy-to-use interface for patients and health professionals alike to ongoing clinical trials, clinical trial results and complementary information on related issues. Link: http://www.ifpma.org/clinicaltrials 2. Registry of federally and privately supported clinical trials conducted in the United States and around the world. Link: http://www.clinicaltrials.gov 3. Opportunities for public involvement in clinical research: People in Research helps members of the public make contact with organizations that want to actively involve them in clinical research. Link: http://www.peopleinresearch.org 4. Regulatory Affairs Professional Society: society of professionals engaged in r

BayBiotech.NET In current times demands on laboratory performance are becoming more intensive as the number of new tests and diseases are adding on to our list as well as a greater demand for accuracy in test results is increasing by a much more controlled regulatory environment. In order to meet these demands, laboratory personnel are working on an ongoing basis to improve efficiency and productivity through better control over the operation and function of all aspects of the testing process by incorporating automation and use of computerized system wherever possible. Creation of an efficient Workflow helps make the entire process cost effective and efficient and a framework for creating a workflow may include: 1. Understanding the issues relating to creating a work list 2. Describe ways to minimize laboratory contamination 3. Understand ways to improve labor efficiency 4. Understand key variables that contribute to testing accuracy  Explain the importance of sensitivity