Why Good Records Management Is Key

Authors: Eldin Rammell & Karen Redding (Phlexglobal Ltd)

The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be signing
more preferred partner deals, such as Pfizer teaming with Parexel and ICON, and
Takeda’s deals with Covance and Quintiles, which is driving mid-size CROs
growth through major acquisitions. There has also been a big shift in
outsourcing services to preferred partnerships, with large CROs outsourcing
niche services to small CROs on a functional basis. Sponsors are also assessing
their current tasks and outsourcing those that require non-core expertise. One
niche area that companies do not always consider outsourcing is document control.
Document management is essential in the pharma industry but can be difficult to
optimise, so working with an outsourcing partner can be valuable.

Good records management

Good records management is crucial in the pharma industry. One of the most common
problems we see is individuals and teams retaining their own copy of documents
rather than utilising a single central source, preferably made available via an
electronic document management system (EDMS). In our highly regulated
environment, demonstrating the reliability and authenticity of documentation is
critical, so individuals making use of a central definitive source for their
records is particularly important. In addition, much time and money is wasted
through duplication and mismanagement of documents when carried out in an
uncontrolled manner.

In some industry sectors, management have introduced strict controls over where and how
documents may be saved. Some organisations, for example, prevent documents from
being saved anywhere except in an authorised EDMS. Perhaps this is one step too
far, but good document control is necessary to achieve regulatory compliance.

Another problem we often see is poor version control, particularly for draft documents. As there may be a need to demonstrate appropriate review of draft documents, it is essential that any review signatures and comments be unambiguously linked to the associated document. This requires a formal system of version control within the organisation.

Once a pharmaceutical process has been completed—whether
a clinical trial or the production of a batch of drugs—the only thing remaining
to demonstrate regulatory compliance is the documentation audit trail. This is
why adequate quality control is so important. It is not enough just to have a
record of what happened; regulatory authorities have an expectation that you
can demonstrate those records to be accurate, legible, contemporaneous,
original, attributable, complete, consistent, enduring and available when
needed (1). A well-designed quality system will ensure that documentation being
sent off to the archive is “fit for purpose”.

Poor quality control can be recognised when a sponsor is
notified of an impending regulatory inspection. All too often, there is a mad
panic as documentation is retrieved from various filing systems and hours are
spent checking files for completeness. This is wasted effort and diverts key
personnel from their core activities. A robust quality control system should
eliminate the need for these eleventh-hour activities and result in
inspection-ready files. Furthermore, quality control should ideally be embedded
within existing processes rather than being introduced as an additional
process. It is better to prevent poor quality records from being generated
rather than identifying poor quality records and having to expend effort in
fixing them.

The vast majority of regulatory requirements worldwide
actually say very little about records management, which has been a bone of
contention for years. On the one hand, records management professionals prefer
the need for explicit guidance so that there is assurance they are operating
within the permitted boundaries, but on the other hand, the lack of explicit
guidance gives freedom to define company-specific processes and systems.
However, it would be helpful for regulators to provide more specific guidelines
in areas that are troubling industry the most, particularly where they see
commonly occurring inspection deficiencies.

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 period.

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 data.

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 regulatory inspections.


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).

First Published: PharmaTech.com


About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Records management practice, Technology, TMF. Bookmark the permalink.

One Response to Why Good Records Management Is Key

  1. Pauline Patel says:

    Good stuff from Eldin & Karen as usual!

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