Records and Logbooks

The recording of actions taken is one of the most important elements of a GxP compliant facility. Most procedures specify the completion of a record to demonstrate that the procedure has been correctly followed. Records can either be in electronic or paper form. Paper records range from simple forms to log book entries and complex multipage documents. All companies are required to keep a logbook for the chronological documentation of equipment-related events.

PSC Biotech can help you develop a comprehensive system of records and we can provide resources to draft standard forms and templates. We can help you in the transition from manual systems to automated systems for warehouse management, production systems, and laboratory systems. Our experience encompasses records for:

  • Product and Process Non-Conformances
  • Corrective and Preventative Actions
  • Complaint Handling
  • Receipt of Raw Materials
  • Product Label Inspection and Reconciliation
  • Product Quarantine and Storage
  • Sampling
  • Testing
  • Release
  • Validation
  • Calibration
  • Equipment Maintenance, Cleaning, and Sanitation
  • Training
  • Environmental Monitoring
  • Microbial Control
  • Product Recalls

If you would like more information, get in contact with us directly here.