Our knowledge of IT system validation compliance with respect to UK, European and International regulatory guidelines (MHRA, EMEA, FDA & ISO) is the result of more than 19 years CSV/CSA involvement within the pharmaceutical, clinical study, biotech and medical device industries.

Our aim is to help our clients handle the complex rules and guidelines that these highly regulated industries are subjected to and acting as the customer's guarantee that the necessary cGMP rules, guidelines and latest regulatory trends are observed.  In this way 'regulatory challenges become compliance successes', with regards to:

Consultants hold registered chartered status within their chosen field and are also experienced project managers.  All projects are managed to successfully meet goals for scope, timelines, quality and cost and so incorporating the requirements of the client.

Computer System Validation (CSV), Computer Software Assurance (CSA) & Data Integrity (DI) Compliance

• System data integrity (ALCOA++)/gap analysis

• Sterile manufacturing (cleanroom)

• Aseptic liquid filling

• Clinical study trials (phase I, II & III)

• Cloud-based clinical EDC, Safety and IRMS

• Internal audit/supplier audit/pre-regulatory/expert witness

• FDA 21 CFR Part 11, 210, 211, 820, 860

• Eudralex Volume 4, Annex 1, 11 & 15

• ISO 13485, 14971, 9001

• Sarbanes-Oxley (SOX)

• High-speed packing lines

• Laboratory automation/robotics/analytical systems

• Facilities monitoring/access control/SCADA/MES/ERP

• GAMP 5, cGxP, SDLC, gap analysis, risk assessment, gap analysis & remediation planning

• System qualification (IQ, OQ, PQ) protocol

• Machine virtualisation/data archiving

• Electronic data migration & virtualisation

• System retirement

• Business continuity/disaster recovery planning

• CSV/CSA/CSQ documentation suite compilation

Audit Related

• Internal audit/supplier audit/pre-regulatory/expert witness

• FDA 21 CFR Part 11, 210, 211, 820 & 860

• Eudralex Volume 4, Annex 1, 11 & 15

• ISO 13485, 14971, 9001

• Sarbanes-Oxley (SOX)