Progressis Consulting Limited

Services

Pharmaceutical Computer Systems Validation quality management services through the full SDLC of planning through to deployment and to decommissioning for the following:

  • Enterprise Quality Systems: ERP (SAP speciality), Electronic Document Management Systems, Deviation Recording and Corrective Action Preventative Action (DR/CAPA) and Good Manufacturing Practice (GMP) Change Management Systems
  • Multi-site Laboratory Information Management Systems, Lab equipment and equipment data acquisition systems e.g. Chromatography data acquisition systems
  • Validation and IS Quality Assurance services for non GxP IT systems in a Pharmaceutical setting  that don’t require operational Quality Assurance oversight (no risk to patient or product safety)
  • Company divestment driven system data carve out and / or system decommissioning”

Computer Systems Validation / Quality Management and Quality Assurance Services, supporting:

  • Post inspection system remediation projects including gap analysis with follow up and / or corrective action / preventative actions to the following,
    • Remediation to US FDA 21CFR part 11 Electronic Records and Signatures regulation
    • Remediation to EU Eudralex Volume 4 Annex 11, Computerized Systems regulation
  • Computerised System Risk Assessment through the SDLC
  • Data integrity remediation to current regulatory guidance
  • Authoring and input into GMP procedures within procedural frameworks / existing Quality Management System (QMS) frameworks

Specialist Experience of working under the following GxP regulations, guidance and frameworks:

  • US and EU Good Manufacturing Practices (predicate rules) and computer systems applicable annexes;
    • US GMP FDA 21 CFR part 210, 211 and 11-Electronic Records and Signatures.
    • EU GMP Eudralex volume 4, including Annex 11 – Computerised Systems
  • Computer Systems Validation and Data Integrity additional guidance (apart from coverage in predicate rules) from ICH, PIC/S, GAMP, FDA, PDA MHRA
  • Good Clinical Practices regulations and guidelines (EU, US, ICH GCP)
  • Information Security regulations and frameworks like ITIL, InfoSec standards and best practices
  • Financial Controls Regulations Sarbanes Oxley (SOx) for SAP in a pharmaceutical environment
Progressis Consulting Limited

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