Project Management for Life Sciences Companies and Organisations, a more pragmatic and human approach
Amjoco brings over 20 years experience of project managing IT systems, design, development, installation, integration, validation and verification, to deliver information systems that are compliant with regulatory guidelines such as GMP, GLP, GCP and GDP, usually within a GAMP based framework.
Recent Projects have included
An infrastructure validation project for a large US based Pharma company to improve regulatory compliance of an Eastern European facility.
Undertaking a remedial IT validation project for a CRO in Southern England aiming to achieve regulatory compliance with their computer systems and infrastructure, following a Gap Analysis.
A Gap Analysis for a small Biotech in Southern England aiming to achieve regulatory compliance with their computer systems and infrastructure.
Amjoco will support you through the entire Systems Development Lifecycle Process (SDLC). Let us take the strain so you don’t feel the pain.
Gap Analysis and Risk Mitigation
Amjoco has conducted numerous Gap Analyses to establish where systems and procedures are needed and what the risks and cost benefits are likely to be.
IT Project Scoping, including systems requirement analysis and definition
Amjoco has had considerable experience and success in the Project Management of multiple bespoke communication system integration and infrastructure projects with a heavy user facing focus.
Vendor Research and Sourcing
We apply best practice to vendor research and sourcing ensuring that all stakeholders have had a say in the process and that as appropriate we make use of prior experience of vendors. We don’t just look at technical competence but also focus on the fit. The lowest price may not be best value we’ve learnt that the hard way. We are concerned that vendors have a clear brief and are performance managed to deliver on time and to budget.
IT Project Budgeting and Control
The kind of projects we have been involved in can be complex and increasingly need to integrate with existing legacy systems. Examples include:
- £1,000,000 bespoke Image Management system
- £250,000 Oracle Clinical installation
- A new £75,000 communications infrastructure
- A site move incorporating a significant network and storage upgrade and
- £80,000 virtualisation of key servers
IT System Design Installation Operational and Performance Qualification
We will undertake complete computer systems validation, verification and qualification. We will use the Project Management Methodologies that your company subscribes to or we will use what we know works.
Computer System Integration, including multiple systems and legacy integration
A particular issue of any existing or legacy system can be compatibility with new systems. Our approach is to review both legacy hardware and software and plan and cost these into system integration. This reduces the risks of unforeseen issues and can ultimately reduce time to implementation.
Computer Systems Validation Methodologies
We can develop and deliver full CSV methodologies from corporate policy to project implementation. We have successfully formulated and delivered corporate CSV methodologies around the globe. We are also highly experienced in the delivery of projects against these CSV methodologies. If you need it we will help you develop test scripts, execute them and even deliver training.
User Training and Mentoring for Computer Systems Users
Training and implementation are typically the last pieces in the jigsaw of new or updated systems development. We help you complete the picture by working closely with key staff and superusers to deliver training on new or updated systems. In time-pressed environments time spent on effective training can make the difference between success and failure, literally.
System Platforms Supported
- Oracle GEMMS
- Oracle Clinical