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.
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.
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.