The FDA has outlined the requirement that all life sciences companies validate (Good Manufacturing Practices (GMP)) systems and processes. While the regulatory requirement is apparent, the FDA has been silent on publishing specific methodologies for achieving compliance. The FDA allows companies to develop and justify their approach to systems validation as long as the software intended uses are properly documented and tested.
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The term validation has a very specific and stringent definition as far as pharmaceutical, medical device and biotech companies are concerned. At a high-level, the concept of validation ensures a system is operating as intended. More specific to life sciences companies, validation is a structured process to satisfy a regulatory requirement.
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When it comes to software validation, there is a presumption that home-grown software cannot be validated externally. Organizations tend to operate under the assumption that only those who develop and work with their proprietary software will have the ability to understand its core requirements and intended use. As a result, the validation effort is directed internally, placing a burden on business users.
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Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner. The use of Arbour’s validation product greatly facilitated the process.
Vice President, IT at a Fortune 500 company
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers. Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Chief Technology Officer at a rapidly growing medical information company
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation. Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.
Vice President, IT of a specialty medical device company
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