Compliant Management

We are a small independent company with excellent links across the industry and throughout the validation community via our hands on experience in the industry, through our involvement as invited speakers at industry forums and through links with industry bodies such as GAMP™.

With over 30 years’ experience in the pharmaceutical validation arena and staff qualified in the likes of Prince 2 Project Management and Tick-IT Auditing, we are able to offer a complete and holistic approach to integrating quality, validation and compliance into our clients’ system lifecycle.

We offer a sensible and pragmatic solution to validation, where a risk-based approach is ingrained throughout our methodologies in order to add value to our customer’s.

With experience from small independent pharma companies through to truly global organisations we have worked extensively across the UK, European and Asian-Pacific regions.

In addition to working directly with pharma companies, we have extensive experience in working with outsource and offshore suppliers on behalf of our clients to ensure that their outputs and deliverables meet with regulatory expectations. Whether you are managing your system developments and deployments in-house, outsourced or hybrid, we have the knowledge and experience to bring you an efficient and value adding validation support capability.

We are a UK registered company, with the following details:

  • UK Company Registration Number: 0675182
  • Registered Office: Trident House, 105 Derby Road, Liverpool, L20 8LZ

Meet the Team

We are really please to present our team, who between them have over 100 years’ experience in pharmaceutical quality, validation and
compliance. Each of our resources are fully conversant with regulatory requirements from bodies such as FDA, MHRA and Eudralex.

They are also experts in applying the principles, techniques and controls of accepted industry best practice through the adherence to
GAMP5™ and the associated good practice guides.

We are experienced across a range of pharmaceutical areas including, R&D, Clinical, NPI, Manufacturing and Regulatory. This experience
has been gained form an equally diverse set of engaging organisations, from the smallest of start-up companies to most of the major
global Pharma corporations.

Each of the team is dedicated to helping you plan, deliver, validated and operator your IT, quality and scientific systems in the most
efficient and compliant manner to ensure you maximise your investment benefit whilst meeting regulatory requirements and expectations.

Graham Parker

Graham has a degree in Computer Science, is a chartered member of the British Computer Society
and also has an HND in Electrical and Electronic Engineering. He lectured at University of Wales,
Aberystwyth, is a qualified Prince 2 Practitioner and a trained Tick-IT auditor.

He has specialised in pharmaceutical regulated IT system delivery and compliance for over 20 years
and has support organisations throughout the world. He specialises in general IT system delivery,
data migration projects and data integrity compliance.

He is an active member of the GAMP Special Interest Group on Cloud Computing where he is
leading the creation of a number of features focused on the use of Software as a Service in a GxP
environment.

He is married with two grown up children, enjoys football, motorcycling and horse riding.

Chris Thompson

Chris has an MSc in Analytical Chemistry and has also studied Software Development at university
level. He started his career as an analytical chemist working for a variety of pharma companies
including Celltech Medeva and GlaxoSmithKline before moving to specialise in Computer Systems
Validation and IT Systems Project Management.

His background as an analytical chemist and his technical understanding of IT systems combines to
provide particularly focused expertise in the area of quality control related systems such as LIMS,
ELN, LES and CDS.

He enjoys family life, fine food and wine, walking and renovating old properties.

Arthur Montague

Arthur ‘s formal education is in biochemistry and started his career with the Beecham Laboratories
in R&D, working on metabolic diseases, then novel allergy vaccines from formulation development
and pilot-scale production through to clinical and regulatory support.

He has worked as a “Business As Usual” LIMS system manger in a busy analytical laboratory before
moving on to specialise in a broader quality focused role in manufacturing and research
establishments. He has specialised in Compliance and Validation of laboratory and quality focused
instruments and systems for the past 20+ years in small and large organisations across Europe

Arthur enjoys outdoor life, living on a quite rural smallholding with his long-time partner and their
animals where they embrace the “alternative” lifestyle as far as possible. He is a keen cyclist and
motorcyclist and has recently completed his own home self-build project.

Callum MacRae

Callum has an HNC in Business Administration. He has also studied many of the Software
Engineering disciplines and is a qualified Prince 2 Practitioner.

His early career saw him begin life in accounting for a small contact lens start-up which was later
acquired by Bausch & Lomb – a global eyecare company. This provided the opportunity to move
into an IT Business Analyst role, and later into the role of Software Quality Manager working to
medical device standards.

From there on, Callum specialised as an IT Project Manager in the Pharmaceutical industry
beginning with management of specific system implementations and later progressing to a senior
leadership role with full responsibility for all scientific and enterprise IT systems within a global drug
development and discovery organisation

Callum is able to combine this broad business, management and IT system experience to ensure,
efficient, compliant system delivery.

Callum has a teenage family and enjoys the outdoor life, being an accomplished kayaker.

Ian Maughan

Ian has a BSc (Hons) in Applied Chemistry but has worked on the technical side of the IT world from
the start of his working career. He began his career developing Chromatography Data Systems
before moving on to be a Senior Software Consultant with Cray Systems and later a Solutions
Design Consultant with Sun Microsystems.

Through his technical roles he began to specialise in the architectural design and implementation of major IT systems for use within GxP Pharmaceutical environments for companies including Johnson
& Johnson, GSK, Wyeth and Pfizer.

As a specialist Enterprise and Technical Solutions Architect supporting GxP Pharmaceutical
applications, he is well equipped to bring his laboratory, manufacturing, business and technical
experience together to provide invaluable support for any organisation, whether this be focusing on
strategic adoption of novel solutions or simply supporting the implementation of qualified system
platforms.

Ian’s main interests are travel, which sees him take annual visits to the far reaches of the US and fine
wine which takes him regular visits of French vineyards and Champagne houses.