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CSV Auditing from A to Z

Everything that has an end has a beginning. So after 8 years Trev Simmons will be joining Zigzag Associates, so can provide the same great service but now has the skills of his co-workers to provide even more services.

Trev Simmons A1 IT Compliance is a UK based Pharmaceutical Consultancy specialising in IT Quality Assurance and Computer System Validation.

Based in the South East of the UK, we are perfectly positioned to support pan-European activities without the overheads associated with trans-Atlantic travel.

We have a wealth of experience in helping our clients in all aspects of Pharmaceutical IT Quality Assurance and Computer System Validation, from: vendor selection and oversight auditing; to quality and validation management throughout the software development lifecycle; and maintaining the validated status throughout operation and retirement.

Founded in 2006,  A1 IT Compliance was created as a specialist consultancy company providing Pharmaceutical IT Quality Assurance and Computer System Validation Consultancy, to provide our customers with expertise in IT Quality Assurance Auditing and Electronic Records and Signatures. We recognised that many pharmaceutical companies did not have the resource capabilities to permanently employ specialist IT Quality Assurance and Validation experts within the UK and Europe yet all pharmaceutical organisations are subject to the same international regulatory requirements.

As a result A1 IT Compliance was formed by Trev Simmons to help smaller and non-European centralised pharmaceutical companies, where the demand for geographic expertise may not support full-time employment, gain the much needed access to IT QA expertise avoiding the overheads of employment, or have their existing experts always on the move.

Trev Has been working within the regulated pharmaceutical IT environment since 1994. Trev has held a variety of roles within the Pharmaceutical Industry from IT Developer, Project / Validation Manager through to Quality Management and Quality Assurance, working across GLP, GMP, GCP and GPvP at both a local and global scale. As an IT Quality Assurance auditor, Trev has experience within the USA, Europe and Asia for Clinical suppliers such as CROs, Analytical and Clinical Laboratories, Electronic Data Capture providers (Patient Diaries, IVRS and IWRS), and medical imaging (ECG, Ultrasound).

Our experience covers the full spectrum of system sizes from single user applications to global systems with tens of thousands of users across the GxPs working with full service and data management CROs, Analytical and Clinical Laboratories, Pharmacovigilance and specialist providers (EDC/ePRO, Medical Imaging, IVRS/IWRS).

We can provide our clients with a variety of services from IT Quality Assurance Management and Auditing, to Validation and Training, and because we you only use us when you need us, you could save on both fiscally and environmentally.1&1