PLC / Computer System Validation is a process of “Establishing documented evidence which provides a high degree of assurance that a PLC / Computer System will consistently produce results that meet its predetermined specification and quality attributes.”
Computer System Validation is the technical discipline that Life Science companies as Current GAMP5 Regulation are becoming very stringent use to ensure that each Information Technology application fulfills its intended purpose. ETS provides quality validation services to the Pharmaceutical, Biotechnology and Food & Beverages Industries.
We have the team of talented, committed dedicated & well experienced people to take care and provide excellent services for all type of regulatory requirements. Here we can support you with our vast experience in this field. We validate your systems in cost effective manner to ensure all predicate rules are satisfied with proper documentation of complete activity. PLC / Computer System validation related protocols / reports are compliance under GAMP5 & Pharmaceuticals Regulatory Guidelines. ETS performed PLC / Computer System Validation of following system in leading Pharmaceutical Companies all over India.
Process Validation is the process of establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications. ETS provides services in Process Validation / Thermal Validation / Temprature & Humidity mapping. All our instruments or equipments used for validation activity are sourced from reputed manufacturer. These instruments or equipments are very accurate & reliable. We are doing periodic calibration of our instruments/equipments from NABL Accredited Labs. We are following all standard norms while carrying out the validation activity. Our validation services are already audited by various reputed pharmaceutical companies. We maintain proper documentation of the validation activity like SOP and validation reports.
ETS provides services in Process Validation / Thermal Validation / Temprature & Humidity Mapping which includes:
| Sr.No | Name of Equipment |
|---|---|
| 1 | BOD Incubators |
| 2 | LOD Oven / Laboratory Oven / Hot Air Oven |
| 3 | Orbital Shakers |
| 4 | Water Bath |
| 5 | Refrigerator |
| 6 | Deep Freezer |
| 7 | Cooling Cabinet |
| 8 | Stability Chamber (Temperature + Humidity) |
| 9 | Walk In Chamber (Temperature + Humidity) |
| 10 | Muffle Furnace |
| 11 | Heating Blocks |
| 12 | Vacuum Tray Dryer |
The reporting format consists of Validation Certificate, Diagram indicating sensor location, minimum & maximum temperature for all locations, mean kinetic temperature calculation, graphical representation of temperature v/s time, hot & cold spots identification.
| Sr.No | Name of Equipment |
|---|---|
| 1 | Steam Heat Sterilizer / Autoclave |
| 2 | Dry Heat Sterilizer |
| 3 | Tunnel |
| 4 | SIP of Fermenter |
| 5 | SIP of Vessel |
| Sr.No | Name of Equipment |
|---|---|
| 1 | Room / Area / Warehouse Temperature Mapping |
| 2 | Room / Area / Warehouse Temperature + Humidity Mapping |
| 3 | Cold Storage Area |
Extreme Technology & Solutions (ETS) offers a complete Temperature & RH mapping service for any warehouse facility in compliance to regulatory guidelines. To comply with current guidelines, mapping of a warehouse must be conducted seasonally. We use High Accuracy Sensors which have the capabilities of record temperature and RH simultaneously. We have arranged that type of set up, routine operation of the warehouse is not affected during the mapping study.
Office:Plot No-18, Gut No-128,
Rajesh Nagar, Satara Parisar, Aurangabad- 431007,
Maharashtra, India.
Contact: 09158128899, 9158555510
Email: services@etsworlds.com
sales@etsworlds.com