Company News

Hart Biologicals sign up to ComplianceControl Centre


Hart Biologicals Limited, engaged in the research, development, manufacture, and marketing of a range of "in-vitro" diagnostic products for use in the detection, prevention, and monitoring of a number of medical conditions has signed up to ComplianceControl Centre, an Electronic Quality and Document Management System for SME’s.

Founded in 2002, Hart Biologicals Ltd. are committed, through the company’s vision and capabilities, to providing ground-breaking and quality medical products, to meet the requirements of an ever-changing healthcare field within a highly regulated environment.

Hart Biologicals’ expertise, robust quality system, solid infrastructure, dedicated staff, and state-of-the-art manufacturing facilities have attracted partners ranging from small start-up companies and universities to large multi-national corporations. Hart Bio provides contract services including Product Development, Regulatory Submission, Manufacturing, Customer Service, Sales, Marketing, and Global Product Distribution

ComplianceControl Centre has recently launched a new version of its electronic Document and Quality Management System that will be used to cover all aspects of Hart Bio’s Quality and Compliance Management system. The system will manage documentation, equipment, training records, audits, and corrective actions and preventative actions, to ensure proactive compliance management and will be particularly useful providing visibility of compliance across all Hart Bio’s offices and Manufacturing sites.

Alby Pattison, Managing Director for Hart Bio explains, “Basic regulatory requirements are essential when manufacturing and supplying medical devices. To ensure our products are up to standards with the MHRA, we needed to be sure our document and procedures were taken care of.  ComplianceConrol Centre helps us to automate and control our document in a secure environment, helping to facilitate better maintenance and control of our procedures, instructions, contracts, records and data.”

David Forrest, Chief Executive of Compliance Control Ltd. stated, “We are delighted that our new Software as a Service release gives SME’s the opportunity to access a Quality and Compliance system that is affordable, simple to use and quick to implement”

Forrest continued: “Hart Bio wanted an electronic system to help them stay compliant without a heavy cost or long implementation project. ComplianceControl Centre is an ‘Off the Shelf’ (GAMP®5 Category 3) product, which means that the system can be operational and fully validated within five days.”

Compliance Control Ltd.

ComplianceControl Centre, is a Software as a Service (SaaS) Electronic Quality and Document Management Software System that provides real-time visibility of the complete Quality, Compliance and Validation status of an organization.

It is validated and priced for SME’s, so they can use software to manage their Quality and Compliance and it is applicable to many companies but in particular companies that wish to be compliant to standards or regulations: ISO 9001, 14001, 13485, 17025, OHSAS 18001, 20000, 27000, CE Mark, FDA, MHRA, ICH, GxP, HSE, IIP, etc.

Compliance Control Ltd. provide Compliance, Validation and Quality and Computer System Validation Consultancy Services and Products to the life science and pharmaceutical global markets. Services include Compliance and Validation planning and strategy, Documentation and Testing, along with a series of Auditing services and Computer System Validation Training courses.

 

 

For more information, please visit:      www.compliance-control.com

Compliance Control Ltd.,

Winnington Hall,

Winnington, Northwich

Cheshire CW8 4DU

United Kingdom

Contact person: David Forrest

+44 (0) 1606 871113

 

Hart Biologicals Ltd

For more information, please visit:                   www.hartbio.co.uk

Hart Biologicals Ltd.,

2 Rivergreen Business Centre,

Queens Meadow

Hartlepool,

TS25 2DL

Contact person: Carole Winton

+44 (0) 1429 271100

info@hartbio.com



     
     

Customer References

  • I can certainly recommend Compliance Control as experts in this field and they will add value and deliver on your project. CFO, Major Pharma Company
  • Compliance Controls Consultants brought immediate expertise to our team as part of our drive into the European market. Vice President, Research & Development, Pharma Company
  • We wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements. Business Development Manager, Phama Company
  • I would like to personally express my great appreciation for all your excellent work and great support with the validation of our IT infrastructure and software. Managing Director, Compounding Centre, UK
  • ComplianceControl Centre was selected because it is easy to use, quick to set up, and was a validated, cost effective solution for an organization of our size. We wanted a system that we could rapidly implement. Vice President, Research & Development, Pharma Company
  • Working with Compliance Control Consultants and their software products ComplianceControl Centre and cGARD helped us to understand the regulatory requirements of IT and business systems more clearly. IT Director, Pharma company
  • Using ComplianceControl Centre will help us to ensure that we are always inspection ready, by tracking our critical Quality and Compliance activities. Vice President, Research & Development, Pharma Company
  • It has been a pleasure working with you and your team and I am looking forward to co-operating with your company on similar projects in the future. Managing Director Compounding Centre UK
  • Based on your achievements and delivered results, we have started the process of building up our internal team for continuation of the work started by you. Managing Director, Pharma Company
  • cGARD has become the new rage here ! Sr. Manager, Documentation and Training, Major Pharma Company

 

 

    

 




© Compliance Control 2014