We produce full life cycle packages from: Validation Master Plans, User Requirement Specifications through Installation Qualification, Operational and Performance Qualification to the Summary Reports.
For all of your Positive Material Identification and Non-Destructive Material Testing please visit out Material Testing page.
We can also provide templates for your own editing and specific needs.
On-site and off-site support.
One of our current projects is taking care of the validation life cycle and quality management system for a major medical device company in New Jersey, USA. We are producing the full package for FDA compliance.
1. Full Validation Life Cycle packages for over 900 medical devices.
2. Validation of all processes and equipment
3. Reviewing updating and generating all associated Standard Operating Procedures.
4. All CSV requirements ie 21 CFR pt 11, 820 etc.
5. Up-dating the Quality Management System for compliance with ISO9000, 9001 and 13485 etc.
We have produced Full - Design History Files and Technical Files for Medical Device companies on many high profile products.