ADB Consulting offers our experience in the establishment and execution of non-product software validation processes to support Medical Device and Pharmaceutical Companies, among other sectors. To this end, we possess knowledge and experience in the following areas:
- FDA regulations for the development and manufacturing of diagnostic, implantable, Class I, II, and III medical devices and associated industry regulations such as FDA, AAMI, AIMD, ICH, MDD, ISO,and IEC.
- Document and object control systems, including Documentum, Agile PLM, SharePoint, Scripts, and Master Control.
- Quality processes, corrective and preventative actions, complaints, issues, field service, non conformance, supplier, receiving inspection, and device accountability, product traceability, return goods systems, manufacturing, audits, and training systems.
- FDA warning mitigations, including: FDA 21 CFR Part 11, FDA 21 CFR Part 211, and FDA 21 CFR Part 820.
- Manufacturing and logistics systems, such as those that involve SAP, PeopleSoft, Microsoft Dynamics, and QAD.
- Clinical systems such as Oracle Clinical, ClinTrials, MetaData, SAS, RDC, DataFax, image management systems, labs management systems, adverse event management systems, coding management systems, thesaurus management systems, MEDDRA, WHODRUG, WHOART, clinical study management, and trial management.
- System development life cycle assessment comprising concepts, design, implementation, installation, integration, and maintenance
- Standard operating procedure and qualification protocol development.
- Validation reports for packaging lines, which include validation of oxygen level pacemakers with 8-bit micro-controllers.
- Documentation, testing and evaluation pursuant to IEEE & ISO Standards, such as ISO13485.