Non-Product Software Validation
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:
- Meeting FDA product development and manufacturing regulations for diagnostic, implantable, Class I, II, III medical devices, and meeting related industry regulations such as AAMI, AIMD, ICH, MDD, ISO, and IEC.
- Maintaining documentation revision control using object oriented control systems including Documentum®, Agile PLM®, SharePoint®, Scripts, and Master Control.
- Supporting quality assurance 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.
- Adhering to FDA warning mitigations, including FDA 21 CFR Part 11, FDA 21 CFR Part 211, and FDA 21 CFR Part 820.
- Supporting manufacturing and logistics systems, such as those that involve SAP, PeopleSoft, Microsoft Dynamics, and QAD.
- Running clinical database 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.
- Incorporating System development life cycle assessment comprising concepts, design, implementation, installation, integration, and maintenance.
- Standardizing operating procedure and qualification protocol development.
- Validating reports for packaging lines, which include validation of oxygen level pacemakers with 8-bit micro-controllers.
- Implementing documentation testing and evaluation standards pursuant to IEEE & ISO standards, such as ISO 13485.