highlight projects

Full implementation, availability and performance monitoring of automation systems for a new facility and expansion facility API manufacturing plant CBD crude extract, controlled by Rockwell PCS, Siemens S7-WinCC and Siemens PCS7. Validation compliance activities including data integrity of all associated computerised systems including compliance with the FDA 21CFR Part11 including Data Integrity, Change controls, Risk management and CAPA.

Validation compliance consultancy services to provide governance policies and procedures including site Computerised Systems Validation Master Plan and Qualification protocols templates for all systems, in manufacturing (Siemens PCS7 and WinCC) and business IT (SAP, LIMS) across two sites and harmonization of Crucell Computerised Systems Validation policies with Johnson & Johnson Software Development Life Cycle (SDLC)

Automation systems Validation compliance consultancy services covering GxP Audit of site Manufacturing Computerised Systems, based on GxP critical systems inventory and site VMP and performing Gap analysis to identify compliance gaps against FDA predicate rule 21CFR Part11 Electronic Records and Electronic Signatures (ERES)

Computerised Systems Validation (CSV) consultancy services creating the inventory and site CSV Master Plan and performing GxP Audit and GxP risk classification for all potentially quality critical systems at site (Manufacturing, IT, QA/QC Labs & Business IT (JDE)) in preparation for FDA inspection audit in line with site local and global procedures

Validation consultancy services to Laerdal Medical including generation and execution of Validation Master Plan (VMP) and other validation activities including staff training in accordance with cGMP and FDA 21CFR Part 11, QSR Part820 regulatory requirements and GAMP5

Site wide Computerised systems validation  (CSV)  at DSM Dalry for Vitamin-C manufacture to API grade. Quality Risk assessments & FDA Part 11 compliance, FMEA,  VMP, DQ, IQ, OQ documentation, etc in line with ISPE Good Automated Manufacturing Practice (GAMP) 5 and applied risk-based  approach to reduce the validation effort from 15 months to 6 months 

Computer Systems Validation (CSV) of DeltaV Distributed Control Systems (DCS) for a newly built Bio-Pharmaceutical, Supervision of Factory Acceptance Testing (FAT) activities in line with cGMP and ISPE Good Automated Manufacturing Practice (GAMP) 5 guidelines to leverage FAT results in to Installation Qualification (IQ) and Operation Qualification (OQ). Management of Software Changes in line with Biogen Idec QMS

The retrospective Computerised Systems Validation (CSV) for 17 lines of Legacy FILL, PRINT/SEAL/CARTON, Secondary Packaging systems controlled by Siemens PLCs and WinCC Human Machine Interface (HMI). This included carrying out Gap analysis in line with GSK policies and cGMP to determine the current status of the Packaging systems and the proposed remedial actions to close the identified compligaps

Validation of the Yokogawa DCS and other vender package systems for the newly built multi-purpose Active Pharmaceutical Ingredient (API) plant. Generation and execution of the Computer Operation Qualification (COQ) Testing for the DCS software, Facilities Monitoring System (FMS), interfacing with vender package control systems, based on Controls Commissioning Dossiers, taking a risk based approach to CSV, in line with cGMP, FDA regulatory & GAMP guidelines and Takeda QMS

Computerised system validation of TIROMAT 630 THERMOFORM, FILL, PRINT/SEAL packaging system based on Siemens S7 PLC and OP25 HMI system. Generation and execution of associated CSV related protocols, including VP, IQ, OQ and VR. Gap analysis of all site SOPs, departmental procedures and system specific procedures to establish procedural deficiencies against FDA 21 CFR Quality Systems Regulations (QSR) Part 820 and Smiths Medical QMS. Authorship of top level, quality related site procedures: Configuration Management and Change Control and Training

Prioritisation from an inventory list of over 800 systems in BPM (Bulk Pharmaceutical Manufacture) and QO (Quality Operations), based on GMP criticality and inspection risks, in accordance with Pfizer QMS.

FDA 21CFR part11 assessment of more than 400 GMP related computer-based Process Control Systems including Fisher Rosemont DeltaV, Ferranti DCS, PLCs, HMI/SCADA) and GLP related instrumentation in Quality Operations (QO) laboratories. Remedial Action plans, based on Gap analysis

Saline Water Conversion Corporation (SWCC) Water Automation Distribution project in Saudi-Arabia. SME and solutions architect on the second largest water transmission project in the world at that time. Full implementation of Honeywell SCAN3000 SCADA with Arcom Remote Terminal Units (RTUs) automation system to control and monitor desalinated water distribution from the coast of Yanbu to the city of Medina and the surrounding towns and villages in the west province of Saudi Arabia, covering an area of 17000 square km  

 Fluvirin Manufacture: Performing compliance Gap analysis on Siemens Process Control System (PCS7) automation system and the associated Validation life cycle documentation (VMP, URS, FS, IQ, OQ, VSR, etc) against ISPE GAMP, cGMP guidelines and Novartis QMS ahead of FDA Pre-approval Audit Inspection (PAI).

 QA Validation compliance of SAP Enterprise Resource Planning (ERP) automation system  Ensuring that the computerised system validation (CSV) aspects for the SAP system have been carried out in accordance with ISPE GAMP 5 taking a risk-based approach and that all documentation associated with the SAP system are in line with cGMP, GDP and FDA guidelines 

Re-validation of the AVANTE Enterprise Resource Planning (ERP) System following an upgrade patch.  Installation Qualification (IQ) execution, generation and execution of Operation Qualification (OQ) Protocol and Test Scripts. GDP review of Test Protocols and SOP Documentation in accordance with BPL QMS.

Complete project delivery on  global  projects across Europe, Middle-East and Africa (EMEA). Providing the clients with reactive maintenance and support including Oil and Gas, Automotive, Pharmaceutical, FMCG and Chemical industries. Applying state of the art technologies to optimise production including  servers, network infrastructure and software  design solutions, Human Machine Interface (HMI) and data reporting using Historian SE and Vantage Point SE, SQL, SSRS.  

 Provision of  Automation services and developing software standards  ensuring software developed meets the  required standards.

Managing software solutions for subcontractors ensuring that   

client technical and functional requirements are satisfied whilst ensuring that schemes are implemented within budget.

Providing full project development life cycle documentation (e.g. FDS, P& IDs, IO Lists, FATs, SATs and O&M Manuals) and providing training to client staff and subcontractors.

Interfacing between Operations and the clients for satisfactory delivery of projects within budget and costs timeframe. Designing various control systems for high end clients including the aerospace, food, chemical and pharmaceutical industries. Covering a full project life cycle, taking a project from inception through to design, build test, final commissioning and handover.