Sam Pharma
Services

OUR REPORTS FORMAT:-

All Standard Calibration Reports Confirm to the requirement of ISO 17025.. However, if the client so desires the formats are modified to meet specific requirements. All raw data is recorded on printed forms in duplicate & stored securely. Calibration Stickers & tags ( within plastic pouches) are affixed on to all Instruments. A Validation status sticker put on each equipment.

All Validation reports are printed in a 21 CFR Compliance Part 11 Format.

A backup of all data is safely stored on Hard Disc & Office Computer.

  • Autoclave (Steam Sterrilizer)
    1. All Validation Reports are printed in 21 CFR Compliant Format.
    2. Temperature Measured.
    3. Can measure Temperature & Pressure if Required.
    4. F0 Value Calculation (Each Probe)
    5. Lag Time Calculation
    6. Clear Graphical Data , Detailing Every Sensor.
    7. Sensor Position Details
    8. Minimum , Maximum , Average Temperature For each Location.
    9. Laminated Colour Graph
    10. Clear Sensor Location Diagram
    11. Separate Diagram For Each Load.
    12. Full detailed Reports Listing Every Log
    13. Pre-Post Calibration Report (On Site Calibration)
    14. All Calibration Certificate (Used Validation)
    15. Equipment Details, Cycle Details
  • Tunnel Validation (Ampoule & Vials)
    1. All Validation Reports are printed in 21 CFR Compliant Format.
    2. Temperature Measured.
    3. FH Value Calculation (Each Probe)
    4. Exposure Time Calculation
    5. Empty Cycle/ Load cycle Clear Graphical Data , Detailing Every Sensor.
    6. Sensor Position Details
    7. Minimum , Maximum , Average Temperature For each Location.
    8. Laminated Colour Graph
    9. Clear Sensor Location Diagram
    10. Separate Diagram For Each Load.
    11. Full detailed Reports Listing Every Log
    12. Pre-Post Calibration Report (On Site Calibration)
    13. All Calibration Certificate (Used Validation)
    14. Equipment Details, Cycle Details
  • Thermal Validation (Equipment Validation) With Worst Case Study / Challenges Study. (Door Opened / Closed & Power Failure Off/On)
    1. All Validation Reports are printed in 21 CFR Compliant Format.
    2. 24 Hrs. Cycle Digital Data With Graph
    3. Empty Cycle / Load Cycle Clear Graphical Data , Detailing Every Sensor
    4. Worst Case Study (Door Opened / Closed ) Digital Data With Graph. (We Provide When Each Sensor Went Out Of Limit & When It Came In Limit)
    5. Worst Case Study (Power Of f / On ) Digital Data With Graph. (We Provide When Each Sensor Went Out Of Limit & When It Came In Limit)
    6. Minimum , Maximum , Average Temperature For each Location.
    7. Sensor Position Details
    8. Laminated Colour Graph
    9. Clear Sensor Location Diagram
    10. Separate Diagram For Empty Cycle / Load Cycle .
    11. Full detailed Reports Listing Every Log
    12. Pre-Post Calibration Report (On Site Calibration)
    13. All Calibration Certificate (Used Validation)
    14. Equipment Details, Cycle Details.
  • Temperature, Temperature / Humidity Mapping (Stores / Ware House /Room Mapping) With Worst Case Study / Challenges Study. (Door Opened / Closed & AHU Off/On)
    1. All Validation Reports are printed in 21 CFR Compliant Format.
    2. 24 Hrs. / 48 Hrs./72 Hrs. /07 Days Cycle Digital Data With Graph.
    3. Empty Cycle / Load Cycle Clear Graphical Data , Detailing Every Sensor
    4. Worst Case Study (Door Opened / Closed ) Digital Data With Graph. [ We Provide When Each Sensor Went Out Of Limit & When It Came In Limit] (Temp, Temp.& Humidity)
    5. Worst Case Study (Power Of f / On ) Digital Data With Graph. [ We Provide When Each Sensor Went Out Of Limit & When It Came In Limit] (Temp, Temp.& Humidity)
    6. Minimum , Maximum , Average Temperature & Humidity For each Location.
    7. Sensor Position Details (Top , Middle , Bottom)
    8. Each Sensor Distance From Bottom to
    9. Laminated Colour Graph
    10. Clear Sensor Location Diagram
    11. Separate Diagram For Empty Cycle / Load Cycle .
    12. Full detailed Reports Listing Every Log
    13. Pre-Post Calibration Report (On Site Calibration)
    14. All Calibration Certificate (Used Validation)
  • Steam In Place (SIP) Validation For Pressure Vessel / Tank / Container/Fermentor.
    1. All Validation Reports are printed in 21 CFR Compliant Format.
    2. Empty Cycle / Load Cycle Clear Graphical Data , Detailing Every Sensor.
    3. Minimum , Maximum , Average Temperature For each Location.
    4. F0 Value Calculation (Each Probe)
    5. Lag Time Calculation
    6. Clear Graphical Data , Detailing Every Sensor.
    7. Sensor Position Details
    8. Minimum , Maximum , Average Temperature For each Location.
    9. Laminated Colour Graph
    10. Clear Sensor Location Diagram
    11. Separate Diagram For Each Load.
    12. Full detailed Reports Listing Every Log
    13. Pre-Post Calibration Report (On Site Calibration)
    14. All Calibration Certificate (Used Validation)
    15. Equipment Details, Cycle Details