Audit/Assessment & Engineering Solution ServicesSource: LoJack SCI, Inc.
Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.
Perform an audit of an organization (usually a pharma/biotech company) versus current Good Distribution Practices in the biopharma industry. Prepare a report with observations, root cause failure analysis, and mitigation strategies for the observations.
Perform an audit of an organization (usually supplier of pharma/biotech company) versus current Good Manufacturing Practices in the biopharma industry. Prepare a report with observations, root cause failure analysis, and mitigation strategies for the observations.
- Cargo Security Audit
- C-TPAT (Customs Trade Partners Against Terrorism) Audit
- Cold Chain Risk Assessment
- Environmental Assessment
- Implement improvements in existing integrated cold chain.
- Create new fully integrated cold chain for new products or existing products in new markets.Assist and/or lead qualification of new packaging, monitoring, shipping for an existing cold chain.
- Conduct comparative studies of competing technologies to assist in selection process.
- Conduct transportation simulation tests of biopharma products to assist in the development of transport-stable formulations.
- Write protocols in support of any or all of the above, but especially for qualification of new technologies in existing cold chains.