We are very excited to be a Sales and Delivery Partner for “BatchLine”; A leading new software concept that provides a level of system support for
manufacturing batch records that until recently has been only been available to a few of the leading global pharma
corporations.

Whether you are looking to take your first steps on the Manufacturing 4.0 / Pharma 4.0 journey or simply looking to improve
your “Batches Right First Time”, BatchLine offers intuitive and extensive functionality which is simple to implement and deploy,
providing significant return on investment within a remarkably short period of time (as little as 1 month, but for GxP
environments we expect the full benefit to be leveraged within 3 to 6 months from beginning of initial deployment).

The system has been designed and built for Pharmaceutical Manufacturing from inception resulting in a fully compliant EBRS
capability. All user activities are timestamped providing major improvements in Data Integrity standards and compliance.

All Batch Specifications (Recipes) are version controlled and must follow the in-built release and version control lifecycle

We offer a compliant Software as a Service (SaaS) hosting provision; either single tenant or multi-tenant. Alternatively, if
required, we can supply the packaged software for “on-premise” installation and operation.

Key Features and Benefits
  Traditional Paper Batch Records BatchLine EBRS
Parallel Review of Exceptions by QA
Immediate Visibility of Expectations to QA
Remote Review of Batch Record Execution
Ability to automate Yields and Reconciliation
Automatic calculation of API for batch potency
Compliant with Data Integrity Expectations
Support for “Release by Exception”
  Traditional Paper Batch Records BatchLine EBRS
Parallel Review of Exceptions by QA
Immediate Visibility of Expectations to QA
Remote Review of Batch Record Execution
Ability to automate Yields and Reconciliation
Automatic calculation of API for batch potency
Compliant with Data Integrity Expectations
Support for “Release by Exception”

Our IT Quality Management System embodies a single, integrated set of procedures, work instructions and templates, which
together provide a scalable IT governance “Toolkit” that can be used for any size or type of IT system.

It provides an end-to-end process to support the full system lifecycle from inception through to decommissioning. It is
aligned with key industry guidance as outline in GAMP5™ to ensure all aspects of good IT practice and pharmaceutical
specific expectations, included risk-based principles and data integrity, are embodied within its processes.

The overall approach is presented in a clear, logical and graphical framework, which in, turns support a simple and intuitive
navigational and training aid to the constituent procedures, work instructions and their dependencies.

The overall framework is presented in a single overarching “framework” procedure (IT_SOP_001) with each of the associated
phases being covered in detail in child SOPs.

In addition to supplying the QMS itself, we can also provide any necessary consultancy support required to assist the process
of embedding the QMS with your organisation, associated business change, training and support in its application.