SOFTWARE SOLUTIONS FOR BIOTECH

Regulated documents. Compliant software for biotech.

Our document creation, management and security solution ARENA/Control comes into its own as a cost-effective alternative regulatory and compliance solution, when compared to the license fees associated with enterprise scale solutions that are way beyond the financial reach of most early stage biotech businesses.

ARENA/Control is the ideal controlling application for ANY electronic document, including:

  • Standard Operating Procedures
  • Validation Documents
  • Clinical Trials (Technical Writing)
  • QMS Documentation
  • Supply Contracts
  • Project Management documents
  • Job descriptions
  • Health & Safety
  • Study results

Computer System Validation / CFR Part 11

Since the creation of ARENA/Control – which was originally built as a solution to a Quality Management challenge relating to computer system validation within GlaxoSmithKline – Tier 2 has amassed considerable experience of delivering software within a ‘validated’ environment.

Specifically, we understand that there are a number of important regulatory considerations relating to the design, development and implementation of custom software:

  • The systems development lifecycle approach.
  • The level and type of documentation produced (including, but not limited to, detailed requirements documentation and test plans).
  • Specific features which must be included in the custom software (such as audit trails, electronic signatures, and security features).

Further, the SLA-based support which complements Red Hat’s JBoss Middleware means it is an ideal technology platform for systems delivered in such regulated environment.

Please contact us to request more information on ARENA/Control

As used by 14M Genomics

Using ARENA/Control as the core ‘engine’, Tier 2 built a secure web portal to support the collaboration between 14M Genomics and the European Organisation for Research and Treatment of Cancer (EORTC) – specifically to provide clinicians throughout Europe access to reports of sequenced and analysed tumour samples.

WHO WE WORK WITH

Crown Commercial Service Supplier

Established in 2002, the quality of our work is evidenced by the stature of our long-standing clients, which include The Scouts Association, King’s College London, Suzuki GB, Simplify Group, Motability Operations Ltd, EDMI, Wolseley UK and Alphabet GB (BMW).

Tier 2 provides custom application development for web, mobile and enterprise integrations to clients across a range of industry sectors. We have particular expertise in the compliant driven worlds of finance and pharmaceuticals, where our regulatory knowledge adds significant value to the project teams we work with in these environments.

Tier 2 now offers Cloud Software Support and technical services around the Red Hat OpenShift Container Management Platform (PaaS) on the G-Cloud 9 procurement portal.

LATEST FROM THE BLOG

17th June 2016 - Tier 2 Consulting builds on its Premier Partnership with Red Hat

We are delighted to announce the continuation of our Red Hat Premier Partner accreditation – which maintains Tier 2’s position within the partner ecosystem as the only Middleware Solutions Premier Partner in the UK & Ireland. Our focus on Red Hat JBoss Middleware solutions and the subscription support provided to new and longstanding clients is […]

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1st June 2016 - Developing Custom Software in a Regulated Environment

21 CFR Part 11 / Computer System Validation Tier 2 has significant experience of implementing systems to comply with the FDA’s 21 CFR Part 11, of which Computer System Validation (CSV) is one key part.  ‘Computer System Validation’, in summary is the documented process of ensuring that a system does what it is designed to […]

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16th November 2015 - Secure web portal for 14M Genomics

14M Genomics is a cancer diagnostic company, based in Cambridge UK and working in partnership with The Wellcome Trust Sanger Institute, to enrich the understanding of the role of cancer genes in the biology of disease. In March 2015, 14M Genomics (14MG) and the European Organisation for Research and Treatment of Cancer (EORTC) announced a […]

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4th June 2012 - Pharmaceutical giant GlaxoSmithKline chooses Tier 2

GSK’s key objective was to create a searchable repository of compounds, including details of studies performed and potential genotoxic hazards. In addition, structural information (with the associated graphical representation) was recorded, providing the ability to complete searches at a molecular structure level. The project was delivered using our quality project approach based on industry standard […]

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