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Computer Systems Assurance the Digital ERA of FDA Compliance
About the Paper:
Compliance for Digital Transformation Nearly a quarter of a century has passed since the U.S. Food and Drug Administration (FDA) established regulations on electronic records and electronic signatures, commonly known as 21 CFR Part 11, under which they are considered trustworthy, reliable and equivalent to the traditional paper records. The regulations provide guidance for organizations that maintain records or submit designated information electronically to the FDA, requiring computer system validation, audit trails, and record retention guidelines necessary for regulatory compliance.
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What is Computer Software Assurance?
Computer software assurance (CSA) is a risk-based approach that limits testing to functions directly impacting product quality and patient safety. CSA also encourages companies to use the software vendor’s documentation to reduce the testing burden and deploy applications faster.
Astrix is the market leader in dedicated digital transformation & specialized staffing services for science-based businesses.
For 25+ years, we have been delivering dedicated information technology consulting, regulatory advisory services and specialized scientific staffing to science-based businesses around the world. We can assist in augmenting your internal resources with expert services and on-demand specialized scientific staffing when you need it. It is our goal to simply do it right – on time – and within budget. We work everyday to create value and build trust with our clients, employees, partners and vendors.
Through our proven digital quality, compliance, and laboratory informatics services we can offer true digital transformation resulting in predictive insights, accelerated product development and superior quality to your patients and customers around the world.
Underpinning this deep desire to satisfy you is a set of core values by which we do not waiver. It is our intent to build trust and value in the business of science and demonstrate the highest level of integrity and quality in all the actions we take and in the results we deliver.
Vested Interest and Ownership, Core Values, Technology Driven and Intensive Desire to Exceed Expectations….. It’s all about being passionate and accelerating value for our customers and partners.