Regulations

Regulations

The environment we and our customers operate in is already and increasingly becoming more regulated. ItemTracker is developed with consideration to these regulations and the general movement to improved practices. As such, we not only develop, test and validate our software to the very highest level using both automated and manual methods, but we also provide services such as configuration, training and validation, to help our customers get the most from ItemTracker. All these services have been developed, using highly skilled personnel with extensive skills built up over many years of practical experience

ItemTracker assists compliance with the Human Tissue Act (European Directive 2004/23/EC) and FDA CFR 21 Part 11 regulations; for example, patient consent for research samples can easily be demonstrated and a complete history shown for samples as all changes are recorded – who, what, where and when.

For more information, see the relevant section below:

 

21 CFR Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The current Good Manufacturing Practices (GMP) requirements set forth in the Quality System (QS) regulation require that domestic (US) or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.

The regulation requires:

  • Specifications and controls be established
  • Devices be designed under a quality system
  • Finished devices meet these specifications
  • Devices be correctly installed, checked & serviced
  • Data be analysed to identify and correct problems
  • Complaints be processed

The QS regulation helps assure that medical devices are safe and effective for their intended use.

Our validation specialists can carry out full or partial audits, internal or second or third party audits by a fully trained expert in the QSR.

 

Human Tissue Act

New legislation on human organs and tissue

Update, March 2007

The Human Tissue Act (2004) came fully into force on 1st September 2006 with the implementation of licensing.

The Human Tissue Authority (HTA) was established under the HT Act as the regulatory body responsible for all matters concerning the removal, retention, use and disposal of human biological material (referred to in the Act as “relevant material”) for scheduled purposes set out in the HT Act. The HT Act stipulates that certain activities can only be carried out under the authority of a licence granted by the HTA.

Useful Links:

Example of ItemTracker use:
http://www.rbht.nhs.uk/search/?q=itemtracker

Department of Health:
http://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/Tissue/Tissuegeneralinformation/DH_4102169

 

 

Human Fertilisation and Embryology Authority (HFEA)

The Human Fertilisation and Embryology Authority is the UK’s independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research.

They licence and monitor centres carrying out IVF, donor insemination and human embryo research. They provide a range of detailed information for patients, professionals and Government.

Click here for more about the HFEA…
Many of our customers are governed by the HFEA, so we pay close attention to the authorities’ guidelines and requirements. We also follow and adapt to any new regulations and policies they introduce.

ItemTracker is a complete sample tracking software solution which meets the stringent requirements as set down by the HFEA. As well as the software, we can also provide related services such as configuration, validation and training.

For futher information, or to discuss your requirements please click here to Contact Us,

 

Good Laboratory Practice (GLP)

Companies within the stringently regulated FDA environment know how vital compliance is to their success. Current Good Laboratory Practice guidelines help regulated companies as they develop, manufacture, and distribute their products in accordance with FDA regulations. Complying with Good Laboratory Practice can be challenging. The team behind ItemTracker believe that compliance is a state, not an event.

Companies all around the world use ItemTracker as their sample tracking and management solution to help them address the challenges of compliance with Good Laboratory Practices guidelines. ItemTracker sample tracking and management system directly addresses the challenges of complying with current Good Laboratory Practice and other FDA regulations. The software solution helps companies automate FDA-required processes.

To be successful in today’s strictly regulated environment, medical, clinical, and contract laboratories must observe GLP requirements while maintaining efficiency.

As the FDA moves towards increasingly stringent regulatory requirements, it is vital for today’s regulated businesses to attain and sustain compliance to compete in the competitive world market. With ItemTracker, compliance in any industry is a state, not an event, as it becomes a part of corporate culture that encourages accuracy, quality, and efficiency—all the ingredients needed for profit and growth. ItemTracker’s integrated solution combines industry best practices with the flexibility needed to address the unique environment and GLP requirements of each company.

 

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is defined as “That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.”

The principles and guidelines for GMP are stated in two Directives; Directive 2003/94/EC for medicinal products and investigational medicinal products for human use.

Compliance with these principles and guidelines is mandatory within the European Economic Area.

Our validation specialists can carry out full or partial audits to suit your needs.

Contact Us to discuss your requirements.

 

GAMP

GAMP 4 is the most widely used, internationally accepted, guideline for validation of computer systems.processes. More than 70 healthcare professionals, from the Americas and Europe, participated in the production of GAMP 4 by contributing to groups producing new and revising existing material.

GAMP 4 is intended for suppliers and users in pharmaceutical manufacturing and related healthcare industries such as biotechnology and medical device. The Guide draws together key principles and practices and describes how they can be applied to determine the extent and scope of validation for different types of automated systems.   One of the key areas is suppliers and their quality systems.

 

Medicines and Healthcare products Regulatory Agency (MHRA)

Medicines and Healthcare products Regulatory Agency
An executive agency of the Department of Health 

The MHRA enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. Underpinning all their work are robust and fact-based judgments ensuring that the benefits to patients and the public justify the risks.

Click here for more about the MHRA…
Many of our customers are governed by the MHRA, so we pay close attention to the authorities’ guidelines and requirements. We also follow and adapt to any new regulations and policies they introduce.

ItemTracker is a complete sample tracking software solution which meets the stringent requirements as set down by the MHRA. As well as the software, we can also provide related services such as configuration, validation and training.

For further information, or to discuss your requirements please click here to Contact Us,