While preparation of Drug Master File or Dossier, an organization would also prefer to manage the documents product wise.

SoluSoft Document Management and Workflow solutions are capable to manage the products with proper versioning and folder structure. The final version of the docuemnts can be then populated in DMF or Dossier Management. Below is a list of supported by SoluSoft solutions.

For managing documents product wise, SoluSoft offers below mentioned functionalities

Product Management

• Updated Stability Database with batch nos and change history
• Updated COA of batches as per current specification and re test
• Current flow chart with change history
• Current Manufacturing Process with change history
• All products starting materials and its flow chart with approved vendor list
• Polymorphic data base
• Data on Genotoxic impurity
• Tracking of Product history of all changes (manufacturing process / specification inprocess,  intermediate,  FP /  Retest Date / starting material vendor/  batch size / impurity profile) etc
• Updated Development Reports, Audit Reports, MV Reports, BMR, BPR, BOM
• All products Technical Agreement, CCP, GTP, TSE’s, Plant and Product Approval, DR profiles, License and Certificates etc.
• Populate final documents from product management to respective Drug Master File or Dossier