SPC takes action all along project’s development for assistance services concerning the validation of automation systems and information systems, in order to implement online qualification answering to specific requirements (nuclear industry, pharmaceutical industry) : 

  • Consulting and Audits : Quality Assurance, compliance to regulation, supplier audit, documentation audit, 21 CFR Part 11 audit…

  • Assurance Quality assistance : assistance for a AQ system / documentation repository implementation or upgrading…

  • Projects validation management : software packages like ERP, GPAO, MES, LIMS, ELN… 

  • Qualification assistance : protocol editing and OQ (Operational Qualification), IQ (Installation Qualification), PQ (Performance Qualification) sheets editing  ; assistance for qualification implementation

  • Training : validation / 21CFR Part 11 / qualification training…

  • Compliance to 21CFR Part 11 : assistance for functional and technical compliance