Renovo’s business
strategy includes being first to market with a pharmaceutical product to reduce scarring.
Renovo currently uses a predominantly paper-based documentation system where documents are
circulated for approval and stored in a central repository. The company decided to complement its
quality management system with a system that would electronically track and manage its
Corrective and Preventative management programme. The decision by Renovo to select the GxPi
CAPA Module, which is part of the x-docs™ portfolio, was based around a key user requirement of
being able to design and configure a CAPA workflow to best suit the company’s need. x-docs™
is a modular platform built on Microsoft SharePoint and facilitates simple compliance with industry
regulations and Renovo has chosen to use the CAPA Module in a hosted system environment
which minimises installation costs thereby reducing the overall implementation and licensing costs
of the product for the consumer.

CAPA process

Corrective action and preventive action (CAPA) is an integral part of any quality management
system and involves the systematic review and investigation of discrepancies or errors in a given
workflow or process in an attempt to both correct detected issues, investigate their root cause and
prevent their recurrence. The investigation of failures is crucial in selecting the most effective
corrective and preventive actions. Regulatory inspectors expect to see a robust CAPA process is
in place and that the organisation can demonstrate a thorough assessment of corrective and
preventative actions has been made within a given timeframe. Quality departments can use
outputs from the CAPA system to report key performance indicators (KPIs) to senior management
highlighting any particular trends or increases in particular types of incidents. This can then be
used by the organisation to target resource and training in particular areas to help maintain and/or
target compliance improvement initiatives.

To verify ongoing compliance, Renovo is subject to routine inspections carried out by the UK
Medicines and Healthcare products Regulatory Agency (MHRA). Current regulations require all
manufacturing and testing processes to be appropriately validated, with records kept throughout
each step of the process to build a complete history of drug development. In 2004 and 2008,
Renovo underwent routine MHRA inspections from the GCP inspectorate and in 2010 its QC
laboratory underwent an MHRA inspection by the GLP inspectorate to verify GMP compliance for
analytical laboratories.

Following each of these inspections the MHRA received responses back from the company which
were accepted and the inspections were closed out without further correspondence being
required.

Selecting the CAPA module

Renovo wanted to integrate an electronic system with its existing processes without compromising
the flexibility offered by paper-based systems. With this in mind, the company looked at several
systems and selected GxPi’s CAPA module because it offered greatest flexibility, ease of
configuration and could be adopted as a hosted system from GxPi’s data centre in Nottingham.
Using the CAPA Module as a hosted system has enabled Renovo to remove the need carry out
extensive installation qualification as this was provided by GxPi and instead focus on performance
qualification testing of the system against pre-defined user requirements. This approach has
significantly reduced the costs associated with bringing in and maintaining a system in-house. The
hosted system is accessed remotely by authorised users via a secure internet connection to the
software stored on GxPi’s validated servers.

To ensure greater visibility of the CAPA process, Renovo wanted a system that could be used by
all departments, rather than just its quality assurance (QA) team.
Renovo was confident in implementing GxPi’s CAPA module because of its established history of
working with GxPi’s consultancy services team. Since 2006, QA/IT consultants from GxPi have
supported Renovo providing expert advice on best industry practice for the development and
validation of computer software. GxPi also had a long history of understanding quality processes
and were not just offering a technology, but understood Renovo’s business, and the regulatory
requirements they worked under. This understanding gave Renovo assurance that the CAPA
module would fulfil both their business process needs and be regulatory compliant.
Renovo commented: “We were attracted to the GxPi’s CAPA solution due to the flexibility of
configuration that the CAPA module offers. Our long-standing relationship with the company
together with the professionalism and support of the consultancy services team was a further
reason for our decision.”

Improving laboratory workflow

The CAPA module from GxPi is based on the principle of “continuous improvement”, allowing for
the collection of customer complaints, internal and external audit observations, inspection findings,
and deviations from systems or procedures. The collection of issues is known as an “initiation”
event. This is then followed by a process leading to the resolution of issues, also known as a
“close out” event. This process can result in modifications to existing procedures and/or systems,
review of protocol designs, equipment repairs or re-training. The CAPA Module minimises delays
to product and document release and sign off by enabling the efficient handling of workflow issues.
As all information on any given CAPA is contained within one document, information can be
handled efficiently with minimal risk of error. As a validated electronic system, the CAPA Module
also provides the assurance that approved CAPAs cannot be altered once data is submitted.
Renovo commented: “We have been really impressed with the way the CAPA Module has
integrated with existing processes. Within the system, we can manage, track and resolve quality
issues effectively. This helps us to maintain regulatory compliance and also raises awareness
across departments of their requirements to comply with regulatory standards of GMP and GCP
activities that Renovo undertakes in the clinical development of pharmaceutical products.”

In addition, QA can easily extract information and produce metrics showing how many CAPAs
have been raised and resolved. A wider internal audience can also be granted visibility of CAPA
information where required, with access extending to departments outside the QA team.

Conclusion

Renovo is using the CAPA module as a hosted system from GxPi to track, manage and resolve
CAPAs within its organisation. The company has invested in the module to assist it with
maintaining compliance with regulatory requirements for clinical development of pharmaceutical
products. Since introducing the module, Renovo has experienced greater visibility of CAPAs
across departments. In addition, the flexible configuration offered by the CAPA Module and the
fact it is being used as a hosted system means that it has caused minimal disruption to existing
processes.