Pharma Compliance DK

Pharma Compliance DK is a small agile independent consultancy firm based in Copenhagen (Denmark) – with a long history & experience (16+ years) of working within the Pharmaceutical/Biotech & Medtech industry, with main focus on:
• FDA “Quality System Regulation” (21 CFR part 820 incl. preamble).
• EMA “Pharmaceutical Quality System” (EudraLex – Vol. 4 – Chapter 1).
• EMA “Qualification and Validation” (EudraLex – Vol. 4 – Annex 15).
• ICH “Pharmaceutical Quality System” (ICH – Q10).

Including other guidance/predicate rules:
• FDA “Electronic Records; Electronic Signatures” (21 CFR part 11 incl. preamble).
• FDA “Quality considerations for continuous Manufacturing”.
• EMA “Computerised Systems” (EudraLex – Vol 4 – Annex 11).
• PIC/S “Good Practices for Computerised Systems in regulated GxP environments”.
• PIC/S “Good Practices for Data Management and Integrity in regulated GMP/GDP environments”.

For complete past and current experiences see:
• Curriculum Vitae (Lead 1) (PDF).

Other areas within IT GxP, includes the following:
• Quality Control/Assurance skills in Electronic Records/Data Integrity (ALCOA+).
• Change Request (CR).
• System Description (SD).
• Configuration Management (CM).
• Data Management & Governance.
• Good Documentation Practice (GDocP).
• IT Compliance oversight (Quality oversight).
• IT Compliance gap analysis.
• IT Supplier Assessment/Qualification.
• IT & GxP Audits.
• Qualification Plan (QPL).
• Integrated Risk Management (IRM) or Risk Assessment Report (RAR)(based on FMEA).
• User Requirement Specification (URS) – with Qualification & Commissioning req.
• Design Review Report (DRR) or Design Qualification (DQ).
• Requirement Traceability Matrix (RTM).
• IQ/OQ/PQ or XQ Protocol (XQP) (incl. Test Plans).
• Configuration Item List (CIL).
• Test Execution & Data Review.
• SAT & UAT on commissioning level.
• IQ/OQ/PQ or XQ Report (XQR).
• Qualification Plan Report (QPR).
• Release Note (RN).
• Regulatory Requirements (FDA, EMA, MHRA, ICH, PIC/S, WHO).
• ISPE GAMP5 “Risk-Based Approach to Compliant GxP Computerized Systems”.
• Qualification of IT Infrastructure.
• SOP / Operation & Maintenance procedures for Computerized Systems.
• Validation of Computer Systems/Applications (VPL / VPR).
• System Management (of Computerized Systems for GxP).
• Periodic Evaluation (of Computerized Systems for GxP) incl. Configuration & User review.
• FDA 483 & Warning Letters.
• Deviation/Non-Conformity (NC) & Corrective and Preventive Actions (CAPA).

• Windows Server / Active Directory / GPO / Windows Registry / Windows Desktop / Advanced Trouble shooting.
• Root Cause Analysis of Computerized Systems for GxP (e.g. Analysis of Windows Dump files and memory leak).
• Perform Physical 2 Virtual (P2V) of older legacy systems (SCADA / Delta V systems etc) that are still bound to physical obsolete hardware – storage of virtualized backups.

Other areas of interest includes: Modern Qualification & Validation/Assurance, Computer Software Assurance (CSA), ASTM E2500, Lean & process optimization, Commissioning & Qualification/Verification, Process Control Systems (PCS) – such as: SCADA (iFix) Applications.

If compliance is expensive… try non-compliance.

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