Compliance to Annex 11 Requirements

Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments. The Life Science industry is part of this stringent segment. They need to ensure the quality of their products because they deal with human safety. The accuracy and efficiency of their work could well be a matter of life and death.

This whitepaper documents ComplianceQuest’s position regarding compliance to Good Manufacturing Practice Medicinal Products For Human And Veterinary Use – Annex 11: Computerized Systems System Requirements.

This Annex 11 has 17 sections. Some of these sections have further sub-sections. We have provided detailed answers to each of these sections and sub-sections in an easy to read tabular format.

Read this whitepaper to evaluate how ComplianceQuest’s 100% cloud-based EQMS system would meet your quality and compliance needs.