Our Validation Services help your company assess develop and implement regulatory compliance at the level you need.
What is validation?
Validation establishes documented evidence that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes. It comprises all activities necessary to obtain this documented evidence: planning, organising, measuring, analysing, reporting and approving.
Validation is done for
- "PROCESS", "SYSTEM", "PERSONNEL" which are known as direct impact systems of an industrial environment.
- Any process concerned with Service or a Manufacturing of a product where the deficiencies become apparent only after the product is in Use or Service has been delivered.
Benefits of Validation
- Customer satisfaction,
- Improved product quality
- Regulatory requirements
IQ/OQ/PQ life-cycle model
Validation follows the life cycle of a product and/or process. The life cycle is broken down into distinct stages and the validation process is broken down into a number of 'qualifications', relating to these stages. The following qualifications are recognised:
- Design Qualification (DQ)
A review of the design for conformance to operational and regulatory expectations
- Installation Qualification (IQ)
Equipment-oriented. Verification of whether material and equipment meet specifications
- Operational Qualification (OQ)
Equipment-oriented. Creating evidence that processes operate to specifications throughout the full range of applications, including worst case testing
- Performance Qualification (PQ)
Process-oriented. Verifying that processes consistently perform as specified within allowed operating range
We Validate
- Tray Driers
- Autoclaves
- Clean rooms
- Environmental chambers
- Freezers/Refrigerators
- Incubators
- Ovens
What we provide?
- Equipment Validation/Qualification
- Standard operating procedures (SOP)
Standard Equipments used
- Data logger: Model DL-120
- Data Acquisition Software: Polsoft (Validation)
- Std Sensors
|
