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EDC Case Studies Read about how Explore Consulting has helped Seattle biotechnology companies implement Electronic Data Capture systems for clinical trials and comply with regulations by auditing vendors. |
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21CFR11 White Paper Download the white paper on Risk Based Approaches to 21 CFR Part 11 by Steve Griggs |
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FDA Guidance on Clinical Systems |
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Clinical Systems Software Development Quality Assurance Regulatory agencies advocate for product safety and efficacy. To balance risk and benefit, regulators must trust that information used for decision making is of the highest quality. The systems that collect, analyze, store, and distribute product information need to comply with quality assurance procedures.
The Good Automated Manufacturing Practice (GAMP4) guide published by the International Society for Pharmaceutical Engineering (ISPE) provides templates for collecting and maintaining software development quality assurance evidence. Explore Consulting uses these and other proprietary methods to assess software development quality assurance practices and evidence at life science organizations and their suppliers. We can provide independent evaluations through audits and summarize findings to focus remediation efforts. Regulation, regulatory guidance, interpretation, and enforcement evolve constantly. Technology continues to advance. Explore Consulting monitors and participates in both regulatory compliance and technology forums to reduce risk and increase productivity for our clients. To find out more about how Explore Consulting can help, contact us. |
Life
science companies must provide evidence of software development
quality assurance so that trust in product information is well founded.
Vendors of computer systems and contract research organizations
(CROs) should help life science companies meet this burden of evidence.