GxP Compliance and Good Documentation Practice

Understanding GxP and how we help you be GxP compliant

The term GxP Compliant is frequently used to refer in a general way to a collection of quality guidelines and regulations.  An abbreviation for Good Practice quality guidelines, the “x” denotes a range of fields including Clinical (GCP), Manufacturing (GMP), and Laboratory (GLP), all of which are part of regulated industries that deliver manufactured products that are fit and safe for use.  GxP guides quality-based research, storage, and manufacturing processes within these industries.  As part of this, Records Management plays an important role in ensuring GxP compliance.

Records Management, often referred to as Good Documentation Practice, is an organisational function devoted to the management of information in an organisation throughout its life cycle, from the time of creation or inscription to its eventual disposition. This includes identifying, classifying, storing, securing, retrieving, tracking, and destroying or permanently preserving records.  Good Records Management relates to advised practices and principles in these areas, to protect the integrity of the records through any retention period.  Therefore, storage of these records is of high importance, to maintain the integrity of information for the entire life of the data.

Our Accreditation and Standards

Ardington Archives provides storage options that meet the exacting standards required by the GxP regulations.  Being accredited to both ISO 9001 (Quality) and ISO 27001 (Information Security) gives clients immediate confidence that their important documents are being stored in facilities that adhere to the highest standards. This is backed up by multiple pharmacovigilance audits carried out by our clients throughout the year. 

Processes and procedures form the backbones of our high levels of service. A full document management system of Standard Operating Procedures (SOPs) is in place with authorised staff access providing version control and an audit trail of changes made. Our staff are fully trained and they are regularly tested to ensure we always deliver in accordance with the latest SOPs.

In the event that we need to make use of a third party, we ensure that they are fully vetted, trained, certified and approved to carry out their job function.

Click here for more details about our accreditation and reputation.

Security and Confidentiality matter to us

The archive facilities are operated by an experienced team.  Various security and preventative measures are in place including 24-hour fire and security monitoring and alarms, whilst fire suppression systems and temperature and humidity control are available in bespoke 4 hour fire retardant rooms – rooms designed to meet the higher standards outlined within GxP.

To ensure the confidentiality of our clients and their data, we utilise a barcode system whereby the barcodes are used to identify the box and its owner.  This removes the necessity to place any potentially sensitive data on the outside of the box, keeping everything private.  To further aid in the confidentiality process collections and deliveries are carried out in unmarked vans, and boxes are stored across all our buildings, minimising the risk associated with all items being collated in one place.