Services

Records Management

Records are a vital resource in any organisation. They provide documentary evidence of what was done, when it was done, how it was done, by whom it was done, and why it was done. Records form the corporate memory required by an organisation to protect its rights and to defend itself in litigation.

It is a regulatory requirement that all parties involved in medicines development, manufacture, research, and safety reporting exercise good documentation practice in the creation, management, retention, and archiving of all records that

  • describe or record the methods, conduct, and results of a study, including key factors, decisions, and actions;
  • confirm that the rights, safety and well-being of subjects and patients are protected;
  • individually and collectively permit evaluation and verification of the conduct of a clinical study and the quality of the data generated; and
  • serve to demonstrate the compliance of investigators, sponsors, and monitors with all applicable regulatory requirements.

Poor records management leaves organisations at risk of non-compliance, litigation or discovery. It is therefore essential that records are valued as an asset and are managed effectively throughout their lifecycle so that they are protected as an investment rather than allowed to become a liability.

Heath Barrowcliff Consulting works with clients to

  • develop logical, stable and durable metadata schema (or folder structures) that reflect the organisation’s functions, activities, and operational needs;
  • develop effective record retention schedules that balance operational needs with statutory and regulatory requirements; and
  • leverage technologies to introduce operational efficiencies and to enhance document and data integrity.


Information Governance

Effective records and information management relies on the development and application of robust policies and procedures to govern the records lifecycle, from creation, through processing, management, retention, preservation, archiving and destruction. Robust governance and good documentation practices are fundamental to ensuring compliance with GxP data integrity and ALCOA++ requirements.

Heath Barrowcliff Consulting works with clients to

  • establish robust records-related policies and procedures;
  • embed a culture of quality management and good document practice throughout the organisation to better ensure ongoing compliance with legal and regulatory requirements; and
  • engineer compliance into technological solutions so that records management is is seamlessly integrated into routine practices.


Technology Procurement and Implementation

Carefully selected technology solutions will facilitate good information governance, provide significant operational efficiencies, and enhance regulatory compliance. However, selecting the most suitable technology then delivering its full potential can be a complex process: implementation is as dependent as much on the appropriateness of the technology itself as forward planning and the provision of effective support, education and training.

Heath Barrowcliff Consultants have successfully completed a number of technology procurement and implementation projects for a range of software solutions including eTMF, eQMS, eArchives, and other content management technologies. It is important to ensure that technology vendors not only ensure regulatory compliance but also enable the establishment of an enduring and mutually successful business relationship.

Heath Barrowcliff Consulting works with clients to

  • evaluate, select, and audit the right technology and vendor
  • advise on balance between value, functionality,  and service provision
  • assess potential operational and compliance risk and remediation
  • assist with change management, processes optimisation, and governance frameworks
  • ensure that robust mechanisms are established to monitor optimal service delivery


Digital Preservation and Archiving

The retention and preservation of study records and source data, is a critical component of compliance with GxP. It is essential to preserve the accessibility, readability, integrity, and (where necessary) usability of these records throughout the entire duration of their required retention so that

  • a study can be inspected and reconstructed;
  • the data generated and the outcomes reported can be understood and verified; and
  • evidence of patient safety can be maintained.

The requirements for archiving digital records are no different to those for physical records but the variety and complexity of digital records requires additional considerations. It is no longer acceptable to archive digital content by simply locking it and storing it: a digital archive must be continually and actively preserve digital content in order for the archived content to be compliant.

Heath Barrowcliff Consulting works with clients to

  • advise on the principles, concepts, prerequisites, and supporting governance frameworks necessary for compliant digital preservation;
  • provide expert insights into- and guidance on- pragmatic, good practice approaches to address digital preservation challenges, especially in relation to obsolescence, digital continuity, and data integrity; and
  • facilitate and support the evaluation, procurement, and implementation of bona fide digital preservation technology solutions.

Training

In collaboration with partners such as the Health Sciences Records and Archives  Association, the Institute of Clinical Research, and the NHS Research and Development Forum, Heath Barrowcliff Consulting offers a broad range of records management and information governance training courses relevant to those working in the regulated life sciences and healthcare sectors, although a significant proportion of the content of that training is equally applicable in other sectors too.

Heath Barrowcliff Conusltants are available to develop on-demand, bespoke training, workshops, and webinars for clients whether related to themes (e.g. inspection readiness) or specific projects (e.g. eTMF implementation).  

Current courses include: