Software Validation

In today’s GXP environments software validation has become a true topic of internal discussion. But the simple fact is that it’s a must:

Section 58.61 of 21 CFR Part 58 Equipment designrequires every "Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol..."

Section. 11.10 of 21 CFR Part 11recommend "procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records... shall include a Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

ZefSci has already created internal SOP that is easily adaptable to your environment. With our step by step program, VMP (Validation Master Plan) and risk assessment documentation ZefSci can deliver quality software validation on these data acquisition platforms:

Analyst 1.3 and above