The role of Good Documentation Practices on Compliance Activities

The role of Good Documentation Practices on Compliance Activities. An acceptable definition of Good Documentation Practices (GDP) would be the prescribed standards by which documentation is created and maintained in the pharmaceutical industry. The FDA has set some GDP standards, but these are not the only GDP standards. There are others that come under the […]

Most Common Problems of Software Validation Processes

Most Common Problems of Software Validation Processes. Software validation processes have always been important; yet, they acquired a special sense of urgency and added importance following the announcement in August 2010 by the FDA in this regard, in which it stated that it “…will be conducting a series of inspections in an effort to evaluate […]

Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations. The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive […]

Supplier and Internal Auditing

Supplier and Internal Auditing. The criticality of auditing to the field of medical devices can never be understated, because medical devices play a direct role in human safety. Supplier and internal auditing are separate, but related aspects of the supply chain and quality aspects of medical devices. It is a common practice in the industry […]

Verification and Validation of HACCP

Verification and Validation of HACCP. Hazard Analysis Critical Control Point (HACCP) is a mechanism meant for ensuring food safety. It is a comprehensive set of guidelines that straddles across the food supply chain, right from harvest till the time it is consumed.Being such a systematic and total approach; HACCP attaches utmost importance to prevention of […]

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle. Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of […]

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is […]

Satisfying compliance for 21 CFR Part 11 is very important when considering cloud hosting

Ever since the sensational arrival of cloud computing on the IT industry horizon, it has made life different in more ways than could be imagined, to make an understatement. With organizations realizing the enormous advantage cloud computing offers; almost every conceivable type of document is being pushed to the cloud. The advantages are obvious, but […]

Meeting FDA Expectations on Supplier Audit Program

The FDA, being what it is; has enormous power over the working of a medical device’s supply chain. It can virtually intercept a medical device at almost any stage through its various mechanisms such as recalls, injunctions, seizures and others. In its enthusiasm to ensure higher quality for medical devices, it has sometimes gone overboard […]

More Guidance Regarding Medical Device Development Tools from the FDA

In line with the aim of accelerating medical device development, the FDA has issued its as-yet latest guideline, entitled “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (called just the “Draft Guidance”) on November 13, 2013. This guideline is a voluntary process for the qualification of Medical Device Development Tools (MDDT) […]