Digital transformation has transformed pharmaceutical manufacturing.
Cloud-based Enterprise Resource Planning (ERP), quality management, laboratory and manufacturing systems now receive regular feature enhancements, security patches and functional updates, allowing organisations to innovate faster than ever before. However, every software update introduces a challenge that receives far less attention than the technology itself: maintaining compliance.
For pharmaceutical manufacturers operating in regulated environments, software updates are not simply an IT concern.
They are a validation and compliance obligation. Every change must be assessed, appropriate testing must be completed and evidence must be retained to demonstrate that regulated systems continue to perform as intended.
Although software vendors are responsible for building and testing their own products, regulatory responsibility ultimately sits with the pharmaceutical company using them.
Validation doesn't end after implementation
Guidance from the US Food and Drug Administration (FDA), together with ISPE's GAMP 5 guidance, makes one principle clear: regulated organisations are responsible for ensuring that computerised systems remain validated throughout their operational lifecycle.
Validation is therefore not a one-time project completed at implementation.
It is an ongoing process that ensures systems remain fit for their intended use as they evolve.
Whenever software changes, organisations must determine:
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