regulated documents, compliant software for Biotech and Pharmaceutical companies

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.

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SECURE WEB PORTAL FOR 14M GENOMICS

“Tier 2 Consulting came highly recommended for this project and the depth of their sector knowledge became apparent from the outset.
We are delighted with the outcome and the work delivered by Tier 2 Consulting”

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From the blog

WHO WE WORK WITH

Crown Commercial Service Supplier

Tier 2 provides high quality web application development and systems integration services to clients in a range of industry sectors. We have particular expertise in the compliant driven worlds of finance and pharmaceuticals and our regulatory knowledge adds significant value to the project teams we work with in these areas. The long-standing nature of the relationships we have with global brands and prominent UK businesses is testament to the quality of work we deliver.

As from 22nd May 2017 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.

GlaxoSmithKline • Evident • Shell Shipping and Trading • Red Hat • Lloyd's of London • Invapay • Suzuki GB • King's College London • Bowring Marsh • Evident Legal • DNVGL • Netdev • Attenda • Blackboard / WebCT • Munich Re • Motability Operations • Croton Stokes Wilson • Decus Insurance Brokers • Cambridge University Press • Wincanton • Guy Carpenter • Document Risk Solutions • Advanced 365 • Sapient • Exari
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