The bottom line is the need to have documented processes and robust document management systems (either electronic or physical)
that permits the demonstration of the above-mentioned attributes. The most common regulatory failures are an inability to
locate requested documents (because they have not been generated, have been lost or destroyed, or stuck in a chaotic filing
system) and poor quality records. Inspection findings related to quality typically cite a lack of appropriate signatures,
missing pages, and missing document attributes, such as no page numbers, dates or document reference identifiers. As previously
stated, the best processes are ones where quality is checked before a document is signed off or used; poor quality records
never find their way into the files as they are corrected before they become final.
Meeting regulatory requirements
One of the key points to note is that few regulations have thoroughly addressed the electronic environment that we are now
working in. As such, it is extremely important that organisations pay attention to the predicate rules — those regulations
and guidance documents that are applicable to traditional hard-copy data and documents. Moving into the electronic arena,
perhaps the most important requirements are the need to use appropriately validated systems (2) and to design data and document
management systems that maintain the integrity, authenticity and completeness of the content for the full term of the retention
Regulations mandate that some data be retained for the marketed life of a product. In these cases, it can be challenging to
address the potential problem of software, operating system and hardware obsolescence (i.e., the ability to retrieve and read
data in ten, twenty and thirty years’ time). One solution is data migration or the use of enduring file formats. Data migration
requires the regular transformation of data from one file format and/or hardware platform to another across the retention
period, ensuring each data migration is complete, checked and fully validated. An alternative approach is to choose a file
format and storage medium that is likely to remain accessible over the retention period, such as PDF/A, TIFF, ASCII or XML.
This is often a lower cost option, but can result in loss of metadata and functionality, such as the inability to re-process
The challenge for industry is that whilst some guidance on long-term electronic archiving exists (3) , guidance from the regulatory
agencies is sparse and often inconsistent. In the absence of guidance, the recommended strategy is to adopt a risk-based approach
in determining electronic archiving solutions and processes. It is also essential that decision-making processes are formally
documented. This documentation should be retained as part of the validation package, which may be requested in the event of
1. EMA, “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools
in clinical trials” (June 2010).
PIC/S, “Good Practices for Computerised Systems in Regulated “GXP” Environments” (September 2007).
2. Guidance on the Archiving of Good Clinical Practice Material (Scientific Archivists Group, September 2007).