What We Do

Scientific and Risk-based approach to CQV to processes, equipment and facilities
Product-centric approach to qualification and validation testing taking into consideration CPP and CQAs
Strong understanding of shopfloor and laboratory requirements
Application of ASTM-E2500 to both equipment and computerised system testing
Strong understanding of ISA S88.01 guidelines in CQV of automation systems
Expertise covered: Fill Finish and Sterile manufacturing, drug product and drug substance manufacturing, biologics, chemical API, DCS, HVAC, utilities.

Structured, risk-based and practical approach to CSV / CSA
Expertise gained through deep experience with traditional / legacy system, SaaS and cloud applications such as Veeva and Tulip
Capabilities span from on-premise to cloud-based systems
Sustainable validation lifecycle focused mindset
Expertise covered: MES, eBR, LIMS, LES, Historian, EQMS, DMS, TMS

Manage the implementation of digital systems implementation on single and/or across multi-sites
Project planning, detailed tasks planning, track project progress, schedule, budget, scope and provide project plan forecast
Stakeholder Management - Interface with key customers, vendors, contractors, and cross functional teams
Risk Management - Undertaking risk mitigations and effective deployment of action plans
Vendor Management - Interface with vendors and contractors for the project / resources scope, schedule
Systems covered: MES, eBR, Historian, LIMS, LES, EQMS, DMS, TMS, etc

Regulatory audit - Risk-based approach in delivering GxP regulatory audits
Technical due diligence - Evaluation of buyer's technical requirements against current and potential opportunities at the seller's site / business
cGMP certification advisory - Pre-approval inspection mock audit and preparation
Governance and policies advisory - Framework, SOPs, Forms and Work Instructions for GxP Quality Systems, Manufacturing Operations Management (MOM), Cybersecurity, IT/OT
Project management - Holistic business and risk-based project management
Fractional Leadership - Meaningful and actionable results in a fraction of cost
Interim management - Senior Operations and Quality management personnel