Validation

A unique and very important part of the Life Sciences development lifecycle is validation. Validation requires documented verification that a process will produce accurate results as per the predefined specification. For this to work you need to know in advance that what you describe will function as detailed. And there are usually plenty of details to cover. In fact, validation impacts practically every area and phase of an automation project for life sciences companies.

Most companies base the engineering effort required to create validation protocols and documents on the GAMP guidelines. These documents incorporate the requirement, design, implementation and test and verification phases. The documents that make up these phases will ensure validation compliance of the completed system implementation.

They usually include at least some of the following:

• User Requirement Specification
• Design Spec
• Functional Specification
• Technical Specification
• Coding Review
• Unit Testing
• Component Testing
• System Testing
• Systems Testing
• User Acceptance Testing

Written by AVO Chief

Efren Duarte is Director of Products & Services and AVO Chief (Strategist/Evangelist) at Avocera Products & Services Consulting and principal of the AVMI Group, a market research based venture management firm. The AVO Chief provides 2-Week Money Back Guarantee Product Marketing/Management Services Trial for qualified Startups and SMBs with growth potential. Inquire at avochief@ymail.com for more details.

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