Agile in a Regulated Environment

U S Food and Drug Administration - https://www.fda.gov/
International Society for Pharmaceutical Engineering | ISPE | GMP - https://ispe.org/
Gamp - http://www.gamp.com
The Health Products Regulatory Authority – http://hpra.ie

Good automated manufacturing practice - https://en.wikipedia.org/wiki/Good_automated_manufacturing_practice

Quality Guidelines - http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

Questions and Answers on Current Good Manufacturing Practices—Laboratory Controls - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-laboratory-controls

Essential medicines and health products - https://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/

Contact us to discuss your requirements.

+35387-8240529 +35387-8179688

We at Independent Solutions can help to transform your business in a way that is conducive to scrum, creating a situation where you reap all of the key benefits of agility whilst also accomplishing compliance. Adopting an agile programme is a fantastic way to introduce best practices which will contribute towards your business leapfrogging competitors, reducing development costs and improving the effectiveness of your approach towards achieving regulatory compliance, all of which can be achieved with our close guidance and support.

Four Values Of Agile

  • Individuals and interactions over processes and tools

  • Working software over comprehensive documentation

  • Customer collaboration over contract negotiation

  • Responding to change over following a plan