CaliberAPQR configures templates based on the SOP, structure, and ease of operation. The templates can be prepared and made available for the users to generate APQRs.
A typical APQR template consists of:
Information is collated from various documents to prepare APQR. CaliberAPQR configures templates based on the data available. The data is audit trailed and can have reviews and approvals. All the documents are electronic records and carry electronic signatures as per 21CFR part 11.
For easy use, CaliberAPQR recommends excel templates based on the type of data like data of critical parameters of manufacturing, equipment details, test parameters of QC, CAPA, market complaints, etc.
Each template can be configured for section of reviewers and approvers and for final document review and approvals. The review and approvals can be user or group-based.