Equipment & System Division
The best company to deliver qualification and validation
The best company to deliver qualification and validation
By GMP law, Equipment and Systems that have a direct impact on the pharmaceutical drug quality, or on medical devices, should be validated. This is to prove that the expected performance can always be reproduced.
DOC's Equipment & System Division can organise and execute qualification and validation of new or in use existing Systems; the several activite are fully traced and documented applying the validation Life-Cycle from the User requirements to the Validation maintenance.
Full validation service
DOC offers an extensive range of services related to validation, through our team specialising in functional areas of the pharmaceutical industry. As well as improving compliance performance and process effectiveness, DOC offers a wide variety of courses, available on registration.
DOC Equipment & System Division Team
DOC Equipment & System Division Team
DOC's Equipment & System Division Team is a group of Mechanical and Chemical Engineers who support our clients, providing them with the necessary documents. They also offer support by carrying out 'on-site' work that cover the entire qualification process for pharmaceutical equipment and systems like:
Critical utilities:
| Pharmaceutical Manufacturing Process Equipment for:
|
HVAC System and related controlled classified areas including:
| Quality Control Laboratory Equipment |
Services
Services
Our Automated System Sub-Division is made up of Computer Technicians who provide the Validation of Computerised Control System, as per Gamp 5 and 21 CFR part 11 requirements.
With reference to Validation Life Cycle, Equipment & System Division provides activites and services in the following areas:
System qualification
Equipment and system to ensure a full compilance.
At DOC, our team has in-depth, hands-on experience in the qualification of pharmaceutical equipment and systems, ensuring companies are regulated by FDA, EMA or other Agencies. Our qualification methods involve an ISPE Baseline Guide approach, along with a 'get it sorted' attitude, in order to verify any system's critical aspect.?
Qualification and Validation Consultancy services include:
- User Requirement Specification (URS) preparation
- Functions & Design Specification revision (FDSI)
- Quality Risk Management (QRM)
- Traceablity Matrix
- Validation Master Plan
- Design Qualification and Enhanced Design Review
- Qualification protocols writing and execution for installation, Operational and Performance Qualification
- Change Control Assessment
- Standard Operation Procedures (SOP) development
Validation Maintenance
The right programme for the calibration and maintenance of test and measurements equipment.
The right programme for the calibration and maintenance of test and measurements equipment.
FDA and EU regulations require that companies have a programme for the calibration and maintenance of test and measurements equipment. The programme should include: intervals, scheduling, specific procedures, and limits and remedial actions in the event that the equipment does not meet established requirements. With our expertise, and the fact that we use the highest calibration standards and systems, we can help our clients achieve this. We can also help them maintain the 'validated state' of their equipment and systems, by providing Calibration services, Standard Operating Procedures, Process and System Re-validation and Change Control Management. We offer Calibration services for:
- Temperature, Humidity and Pressure monitoring equipment
- Cry-storage, freezers and refrigerators
- Temperature and Humidity Controlled Environmental Chambers
- Digital Temperature, Humidity and Pressure Controllers
- Central Monitoring Systems
- Analog Pressure, Magnehelic and Vacuum Gauges
- pH meters
- Power Supplies
- RTD Simulation and Measurement
- Thermocouple Simulation and Measurement
- Glass and Digital Thermometers
- Conductivity and RedOX testers
- Flow meters
- RPM testers
Standard Operation Procedure (SOP) for:
- Instrument Calibration
- Maintenance and Preventive Maintenance
- Change Control & Re-validation
- Process and System Re-Validation
- Change Control Management
Computerised System Validation
A great experience in qualifying pharmaceutical equipment and systems
A great experience in qualifying pharmaceutical equipment and systems
Currently, most pharmaceutical equipment is managed and controlled by computerised systems that have to be designed, developed and validated according to stringent quality standards. These standards are defined by International Regulatory bodies and organisations, like FDA, ISO and GAMP. Quality requirements demand specific controls and procedures throughout the Software Development Life Cycle, plus documented evidence, as stated by FDA, that “Computer Systems will consistently produce its specified results and level of quality'.
Acting in compliance with the most updated regulatory requirements, DOC has the knowledge and expertise to plan and carrry out the Static and Dynamic Testing necessary for a successful Computer System Validation. Considering the Validation of a new system, DOC can support users on:
