Quality System Regulations are general guidelines that need to be customized

Key Takeaway: The FDA’s Quality System Regulations (QSR) are a family of wide-ranging regulations meant for a number of industries, as well as a number of medical devices. They need to be applied using the manufacturer’s discretion on what constitutes a state-of-the-art practice. The FDA has issued Quality System Regulations (QSR). The objective of putting […]

Risk-Based Computer System Validation is a remedy to expensive and time-consuming computer system validation methods

Key Takeaway: Organizations that implement a risk-based approach to computer system validation decrease, in the long run, time and cost overruns associated with validation. Computer system validation is a must for organizations involved in a number of businesses and activities. Regulatory authorities such as the FDA, apart from the European Medicines Agency (EMEA), Medicines and […]

Supplier Evaluation and Internal Auditing are crucial for organizations

Key Takeaway: There are many challenges associated with supplier evaluation and internal auditing, but compliance with QSR and ISO 13485 and diligence are the antidote to these. In any organization, continuous and scientific evaluation is a must. This is all the more important for an FDA-regulated industry. Supplier evaluation and internal auditing are done to […]

Diligence should go into Software Validation Process for 21 CFR Part 11

Key Takeaway: Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right. The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR […]

Cash Management: A User’s Perspective – The How’s, Why’s and Wherefores

Overview: Too often, a bank’s commercial customer has to endure multiple sign-ons; navigate to different Websites to access the various ancillary features in the TM suite; and administer security and end-user rights across the suite from several different locations. For banks at which any of these situations are true, it is likely the lack of […]

FDA Device Software Regulation

Overview: Software’s level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device’s performance, make calculations, identify treatment options or begin to play a more active role in making clinical […]

Understanding Typical Components of a Financial Audit Program

What is Financial Audit ? A financial audit is an independent, objective evaluation of an organization’s financial reports and financial reporting processes. The primary purpose for financial audits is to give regulators, investors, directors, and managers reasonable assurance that financial statements are accurate and complete. Financial Audit Process What are the components of a Financial Audit Program? There are various core components of a financial […]

Food Microbiology is a vital area in ensuring food integrity

Food Microbiology is a vital area in ensuring food integrity Food microbiology is a fairly large field of the science of food. Any food, no matter from which source it is derived, which part of the world it is grown in, and what it contains, is prone to attracting microorganisms. These microorganisms, found freely in […]

Good Internal Audit Report Writing Skills are very crucial for an auditor

An internal audit is an important exercise that every organization carries out to ensure that its processes and procedures are adhering to set guidelines and are meeting regulatory requirements. Once an internal audit is carried out; the task of the auditor is to present the findings in an audit report. This is where internal audit report writing […]

Principles of Good Clinical Practices (GCP) Audits

Good Clinical Practices (GCP) audits are crucial to Clinical Research Organizations (CRO’s). This is because they deal with very vital human life for their research. The implications of the research can be very profound. They can change the way diseases are managed, or if done incorrectly or without adherence to sound Good Clinical Practices audit […]