What Life Science companies are doing to ensure Audit compliance

For those in the life sciences industry, audits are a normal and consistent part of their world. Regulatory compliance means all eyes must be focused on product safety and quality. We all take protection for granted, but it is standards such as FDA (21 CFR Part 11), GxP, and ISO 9001 that give business, and the consumer a sense of confidence and security. So, what about your life science organization? Is the intention there, but your knowledge in need of fine tuning?

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How to keep up to date with ISO requirements

The way in which we all do business has slowly but surely evolved over time, and with evolution comes a need for greater regulatory conformity. Time marches on, and inevitably there comes a time for review and acceptance of a new range of guidelines. Yes, just as it seemed safe to go back into the water, many business owners are dragged forward out of the land of complacency into the brave new world of change and modification. So, how do you keep up?

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Why you need to build complaints handling into QA

Complaints Handling Customer dissatisfaction is never a nice occurrence for any business. Nonetheless, it does exist, and within some industries, is growing at an alarming rate. Customers are increasingly demanding, and expect a great deal more than we may recall from previous years.

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The importance of developmental validation In Forensic Science

Validation Forensics The need for a scientific element in today’s medicine and criminology is well known, and it is this awareness that has assisted the creators of modern software to develop an understanding of competencies required in the field. The world of forensics invokes a few thoughts in most people’s minds, but without getting too technical, the science of forensics has originated from the principles of repeatable processes and worthiness of evidence.

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This one QA secret can change your life

What price would you put on time? Can its worth even be quantified? Sure, there’s the time of external advisors you’ve brought in to offer advice and consultation. A by-the-hour cost to the company is certainly relatable to time, but surprisingly many organizations fail to see time itself as a commodity, or with a significance just as vital as any other product or service.

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How to create adequate visibility in your QA Reporting

Quality assurance relies on people, but we in turn depend on it. QA dedicated personnel, and management alike, need to be able to access adequate data, to enable sound business decisions to be made.

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