Equipment Qualification is used as an umbrella term covering the steps that ensure an instrument or equipment is appropriate for its intended use.
Qualification involves testing the equipment to demonstrate that it does what it is supposed to do. A system and/or equipment must be qualified to operate in a validated process.
The requirements for validation/qualification are now explicitly stated in both the US and European Regulations (US Code of Federal Regulations US CFR Part 211,subpart L, 211.220 and 211.222 and within the EU ‘Rules
Governing Medicinal Products in The European Community’ VoI IV, Part 5.21, 5.22, 5.23, 5.24).
Kneat can assist companies to design procedures that comply with regulatory requirements and our system will control the process ensuing a high degree of standardization and harmonization throughout the organization thus ensuing that the correct levels of testing is performed on a consistent basis.
Equipment qualification involves documenting the entire qualification process in the validation lifecycle, even after the initial qualification each piece of equipment needs to be maintained within the qualified state by ensuring robust periodic review cycles.
Most equipment qualification projects involve the following activities:
- Validation Master Plan
- Risk Based Impact Assessment
- User Requirement Specification
- Risk Assessment
- Design Qualification
- FAT or Factory Acceptance Test
- SAT or Site Acceptance Test
- IQ or Installation Qualification
- OQ or Operational Qualification
- PQ or Performance Qualification
- Equipment Re-Qualification
- Change Control
- Preventative Maintenance Program
- Standard Operating Procedures (SOP’s)
How Can Kneat Help?
Kneat is a web based application that removes all of the complexities around the equipment qualification process introducing a paperless, lean and compliant process.
Kneat allows you to
- Streamline and standardize your equipment qualification activities
- Embed best practices throughout your organization
- Improve right first time with dynamic data creation
- Replace paper with web based intelligent documents
- Ensure audit readiness
- Reduce cost of compliance
Kneat provides the following features to ensure a smoother more consistent qualification process:
Kneat allows you to seamlessly create validation and project plans from a designated library that have been approved at a higher level thus ensuring the kick off point for each project is the same.
Requirements and traceability matrices can be linked easily through the use of Kneat’s Dynamic Data capability thus ensuring direct linkages and integrity of data.
Risk assessments such as failure more effective analysis (FMEA) can be created and reviewed collaboratively leading to faster approval times. Through the dynamic data feature all requirement can be seamlessly linked to the appropriate risk scenarios.
All documents created within Kneat are web based thus allowing collaboration with one version of the truth. Unlike other traditional file management systems Kneat ensures all documents are managed with security and data integrity at the forefront…..no more checking documents in and out of the system.
Online Paperless Testing
When test document are pre-approved they are transformed into a 21 CFR Part 11 friendly system where all test activities can be performed online including the seamless management of test evidence and deviations.
All periodic review schedules can be managed within Kneat where designated parties will receive email notifications periodically alerting them of upcoming activities.