Karen Redding. Global business development director at Phlexglobal Ltd.
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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.
Eldin Rammell. Managing director at Rammell Consulting Ltd, a sub-contractor of Phlexglobal Ltd.
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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.
