How to transform the obligation of quality reporting into an opportunity

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In addition to the regulatory obligation for traditional PQR/APR reporting, both the EMA and FDA emphasize the implementation of ongoing/continued process verification as integral part of validation activities throughout the product life cycle.

The effort for the timely preparation of related quality reports is immense since many manual activities are involved in data acquisition, statistical analysis and the final compilation of validated documentation. To unburden you, we have kicked-off the development of a modular software platform for on-demand quality reporting!

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