Web Document Management in GCP Environments: Technology that Reaps Real Results

In an environment (i.e., a GCP regulated environment) where keeping track of information reigns supreme technology enablers are becoming not only commonplace but necessary to maintain the pace of life-science competition.

GCPs


GCPs or Good Clinical Practices are regulated not only by the FDA but by the ICH and additional regulatory bodies/organizations. GCPs ensure the safety and effectiveness of clinical trials throughout the various phases of clinical trials and strive to provide a trustworthy--and progressive--framework for process development. However complying with GCP standards becomes exponentially difficult as clinical trials are performed in more than one location (i.e., outsourcing, etc.) and manual processes fragment the transfer and retrievability of critical information. This "fragmentation frustration" is perhaps most evident in the management of documentation.

Web Document Management in GCP Environments


Many GCP regulated environments should--if they haven't already--invest in a web document management solution. Not only are web document management solutions sophisticated enough to provide specialized solutions for the needs of life science environments but are also (when implementation and validation are planned carefully) become ROI generating machines. Some of the benefits that a good web document management solution can provide would include the following:

• The automation of document routing processes which becomes essential when documentation (e.g., SOPs, policies, adverse events reports, etc.) need to be quickly viewed or approved by IRBs, clinical investigators, LRECs or MRECs;



• The ability to track any type of document;



• A centralized document repository where all documents can be easily searched or retrieved. This is especially valuable during audits or inspections;



• Web-based functionality that makes it easy to share real-time information with all groups with responsibilities during the lifecycle of a clinical trial;



• Automated revision control;



• Accountability requirements for all users who make any changes to documentation (i.e., they are required to provide a reason for any change made during the lifecycle of the document);



• Can be used as the center of all quality systems;



• Can provide collaboration capabilities;



• Can be integrated with audit control and process management solutions (e.g., deviations management, customer complaints handling, CAPA, change control, audit control and training);



• Analytics capabilities;



• Reporting capabilities.

Expediting Information with More Efficiency


With a web document management solution that provides at least the features mentioned above, a GCP regulated environment should be able to more effectively retrieve and edit critical information. For example, section 5.17.1 of the ICH's GCP regulations requires that "The Sponsor should expedite the reporting to all concerned investigator(s)/institution(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected." This requirement for expedition cannot be effectively carried out when searching for a document, retrieving it, editing it and providing a document trails can literally take months. With an appropriate web document management solution however expedition can be carried out in a small fraction of the time originally required via manual processes.

Conclusion


The difference between manual or hybrid documentation processes and process controlled with a web document management solution can mean the difference of thousands of annual administrative hours saved every year and a solution can be determined and implemented quite easily when a quality or compliance representative is specifically given the task to find an appropriate web document management solution.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To learn more about web document management in GCP environments, please feel free to contact a MasterControl representative.