PharmaMatrix can provide biopharma companies with technical support staff to augment your internal team to author and execute IQ, OQ and PQ documentation to meet and exceed the requirements of an audit. Documentation can also include calibration and preventative maintenance SOP’s.
Internal Audit Preparation and Response
PharmaMatrix can assist and prepare your Quality Dept for both internal and external audit (client or Federal agency).
- Document and Data Review
- Conduct internal process audits to detect and correct non-compliance
- Author SOP documents
PharmaMatrix can assist your Quality Department with audit responses with respect to 21 CFR Part 11 compliance.
PharmaMatrix can assist your Quality Dept with audits of proposed vendors.
* All engineering services, including automation and controls, instrumentation design, and commissioning and validation, provided by associated entity KWW Engineering, PLLC (P-1686).