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.