Qualification is a critical process in ensuring that systems, equipment, and processes meet predefined standards and regulatory requirements. It involves a series of tests and verifications to confirm that everything operates as intended and is fit for its intended use. Being a critical process for the pharmaceutical and biotechnology industry, key aspects include:
- Design Qualification (DQ): Verifying that the design specifications meet all regulatory and operational requirements.
- Installation Qualification (IQ): Ensuring that equipment and systems are installed correctly according to design specifications.
- Operational Qualification (OQ): Testing to confirm that equipment and systems operate within specified parameters under all expected conditions.
- Performance Qualification (PQ): Verifying that systems and equipment perform effectively and reproducibly in real-world conditions. This step also verifies the user requirements specification.
The qualification process is essential for ensuring compliance, reliability, and safety in various industries, particularly those with stringent regulatory requirements such as pharmaceuticals and biotechnology.
Our team specializes in comprehensive qualification services to ensure that your systems and processes meet the highest standards of quality and compliance.
