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In the Pharmaceutical industry, the meticulous work required to complete the software validation process is not something many professionals wish to repeat more often than necessary. Certainly, the initial implementation of a validated system should not have to be endured more than once.

Though the software validation process is extremely rigorous, Pharma companies who endure reap the benefits of labeling artwork management: gaining control and ensuring quality with a reliable software product. Validation proves that technology products reliably execute the company’s proprietary process in a repeatable, predictable manner, requiring screen shot test evidence and specific scripts to document this capability.

Rigor is not optional. 

 

That’s why it’s very important to get implementation and initial validation right the first time. You don’t want to re-live it, and you shouldn’t have to. It’s difficult and costly.

Typically it’s the role of Procurement or Regulatory to vet software options. Here are some key questions to help you understand if a prospective partner can be successful:

  • How long has the partner been working with Pharmaceutical companies?
  • How many validated deployments has the partner completed? How many is the partner working on right now?
  • When did the partner’s last Pharma customer go live?
  • Has the partner ever failed to deploy a system they sold into a client?
  • What kinds of comments did previous Pharma companies make at the end of their audits? Were there any negative material findings?
  • Has the partner ever been qualified by another Pharma company?

When choosing a software platform and partner to implement it, you want to have full confidence that the provider can get validation right the first time. Asking these questions can help you and your colleagues choose wisely and avoid unnecessary pain and wasted expense.

Read about our Validation Services.

 

Topics: BLUE, Technology, Pharma