Document Everything – look through the rule, pick out each standard and each implementation specification and create a chart that briefly describes how you are addressing each. – Require and use strong passwords – teach your staff andcoworkers how to create them – Limit systems access to those who absolutely need it for their jobs Read more about Security best practices under HIPAA[…]
A quality agreement is a crucial document that defines the responsibilities and expectations of the parties involved in the manufacturing of pharmaceutical products. The quality agreement helps in ensuring that the product is produced in compliance with the regulatory requirements and also meets the quality standards. One of the essential aspects of the quality agreement is Read more about How to Organize the Quality Agreement for Drug Products Manufacturing[…]
21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]
1977 Congress passes FCPA act to stop bribery and restore public confidence in U.S. business systems. it has 2 sections Anti -Bribery and accounting provision. Anti-Bribery provison is enforced by DOJ (department of justice) and it helps in Prohibiting corrupt payments (bribes) to foreign government officials, political parties, party officials and candidates in order to Read more about Anti-bribary provisions in FCPA Act[…]
There are three primary set of export and sanctions rules. These are: U.S. Export Administration Regulations (EAR) International Traffic in Arms Regulations (ITAR) Economic Sanctions Regulations U.S. Export Administration Regulations Export Administration Regulations (EAR) are found in 15 CFR Parts 730 to 744. These are administered under International Economic Emergency Powers Act by the Commerce Read more about U.S. Export/Sanctions Laws[…]
The residence rule changed to “State of celebration” rule & applies when determining an FMLA-covered spouse now recognized nationally. New rule expressly includes same-sex and common-law marriages including those entered into outside the US
The various methods of allergen labelling are as follows : All retail products must have Allergens labelled. Restaurant employees must be able to control and discuss allergen presence with customers. Common names must be used The allergen may appear in bold following the ingredient containing the allergen, on the label The allergen and Contains statement Read more about Allergen Labeling[…]
Q – Is it mandatory to have system requirements should be high level and functional specifications be detailed ? Ans – There is no specifically defined procedure for validation. Different process and terminologies comes under validation. Instead of using different terms like functional requirements, user requirements, functional specs, user specs, design specs, configuration specs, IT Read more about Expert Q&A – in computer system validation[…]
The BSA also requires every US national bank to file a Suspicious Activity Report (SAR) when they detect certain known or suspected violations of federal law or suspicious transactions related to a money laundering activity or a violation of the BSA. A SAR filing is required for any potential crimes: Involving insider abuse regardless of Read more about Suspicious Activity Reports and filing Requirements[…]