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Document Management System and Case Review in the Pharmaceutical Industry
Implementing best practices for document management and reviews
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Pharmaceutical companies are highly information sensitive with respect to how documents and records are managed, making efficient document reviews critical not only from regulatory standpoint but necessary for organizational efficiency as well. Stringent regulations have made compliance managers take a serious look at their document review practices. Most pharmaceutical companies constantly face the pressure of delayed and inaccurate submissions. The weaknesses of existing document management and review applications is evident from extra days and months companies are putting in submission review cycles, debating if the right versions of the documents are still floating in some department while erroneous documents have been filed with the regulatory authorities.

MetricStream provides a comprehensive solution that makes the process of reviewing critical document simple and efficient. The solution leverages the role of authors, editors, reviewer, compliers, etc. by ensuring that documents and records submitted to the regulatory authorities, like the FDA, are complete and accurate. The solution also ensures reduction in cost and facilitates information re-use by implementing best practices for document management and reviews.

MetricStream provides a comprehensive Complaints & Audit Management solution for the Food & Beverage industry, giving you a head start by providing dependable automation and regulatory compliance. It ensures effective compliance, reduces food safety risk, streamlines information flow and business processes, improves operational efficiencies and above all helps meet desired quality levels and compliance requirements.

Overview of the Drug Lifecycle

Preclinical Phase: IND Review
Years of research, with continuous testing, screening, and refining takes several years and generates thousands of documents. The Investigational New Drug (IND) submission requires the compilation of everything known about the new drug being developed.

Clinical Phase: NDA Review
Clinical phase is geared toward the submission of an equally important regulatory filing: the New Drug Application (NDA). The NDA dossier is complex and voluminous - anywhere from 100,000 to 600,000 pages of text meant to persuade the FDA to approve the new drug, putting major responsibility on the document review process. The sponsor must comply with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) for its NDA submission.

Post Clinical Phase: Adverse Event Review
After the product is brought to the market, the company continues to submit reports to the FDA, such as adverse reaction reports and quality-control records. These reports are highly sensitive and require through and comprehensive reviews before submissions. The company must address post-market requirements found in 21 CFR Part 314, including the reporting of adverse drug experiences and the submission of NDA field alert report.

 

Challenges in Document and Case Review
Pharmaceutical industry has a complicated structure and depends heavily on research and documentation. Throughout the life cycle of the drug, it is under constant surveillance by the regulatory bodies that require various documents to be submitted. Reviewing each of these documents and ensuring accuracy is difficult. Ascertaining that right documents are filed for approval from amongst multiple versions floating in the organization further add to the complications. Some of the major challenges encountered with existing document management and review applications are:

Inflexible Review Applications: Internally-developed review applications are inflexible and therefore unable to adapt to new processes and compliance requisites

  • 21 CFR Part 11
  • 21 CFR Parts 210-211
  • 21 CFR Part 820
  • Adverse Events
    		•

    Lengthy Review Cycles: Companies risk missing deadlines due to lengthy review cycles.

    Lack of Integration: Lack of integration between data storehouses, document repositories and review applications poses persistent risk of incomplete and inaccurate filings.

    Limited Reporting: Most applications are unable to identify trends or provide analytical charting of the review process.

    In spite of more money being spent on drug development process, the success rate of new drug products is approaching half of what it was 20 years ago, with a 15% decline in new drug applications in last four years1

    Repeated and Isolated Reviews: Most reviews are done in isolation, leading to repeated mistakes and re-iterations. Entering the same information manually into different systems also causes data inconsistency and errors.

    Inadequate Review Tools: Inability to do team reviews and categorize annotations adds to complexity of the process.

    No Issue Parameters: In case of deviation from expected processes, the prevalent systems are unable to segregate issues on the basis of defined parameters.

    Ad-hoc Reviews: No systematic record selection process is carried out and reviews are generally done in a haphazard manner with no guidelines and parameters.

    MetricStream Solution

    “Thanks to MetricStream solution our document review process has improved and the higher quality of reviews has greatly reduced the risk of noncompliance with FDA. We are now able to review 40% more cases with same resources.” Compliance Officer, A Fortune 50 Pharmaceutical Company.

    Effective document review system helps pharmaceutical companies accelerate time to market. It not only simplifies the review process but also brings efficiency in document management system. This proactive approach towards the review process leads to higher quality reviews, greatly reducing the risk of noncompliance while providing 100% traceability of all documents, records and cases across the organization. Some of the key benefits of the MetricStream solution are:

    Automated: Review cycle decreases as the automated workflow takes documents through the prescribed lifecycle without delays and ensures that tasks are completed by their due dates. Electronic workflows, email notifications to author for updates improve efficiency.

    Virtual Workspace: Web access with collaborative tools enables the review team to collaborate virtually making the review process fairly simple and easy to manage.

    Well-Integrated: Integration with the existing data repositories and document management systems like Adverse Event Tracking System, Safety Data Warehouse and Documentum help provide a single integrated system for document review and management.

    Highlights

  • Quick Implementation
  • Seamless Integration
  • User-friendly
  • Built-in Reporting
  • Robust Security
  • Electronic Signatures
  • Audit Tracks
    		•

    Sustains Compliance: Reduces regulatory filing and reporting time. Improves quality and accuracy of the regulatory filings.

    Executive Dashboards: Powerful reports and dashboards with ad-hoc reporting capabilities help the review team to collect previously unavailable metrics on the types of documentation errors for preventive programs and trend analysis.

    Systematic Selection: Systematic selection and assignment of documents to be reviewed helps improve the process and increase efficiency.

    Powerful Review Tools: Facilitates parallel reviews with categorized, central repository of annotations, comments and other inputs.

    Event Categorization: Sampling of Adverse Events and other case records from Data Warehouse based on defined parameters for each drug type helps streamline operations, find deviations and implement corrective actions.

    Case Study - One of the World's Largest Pharmaceutical Company

    The multinational pharmaceutical company with presence across the globe invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. The Safety and Risk Management Group files various regulatory and compliance documents for its wide portfolio of drugs at various stages of product life cycle. Each phase has its own set of governing regulations that require extensive documentation.

    Earlier the system being used for document and case review process was an internally developed application that was not flexible to adapt to the new processes being adopted for reviews and corrective actions. It did not enable Pfizer to identify and correct recurring issues. The group was risking missed deadlines due to the lengthy reviews and incorrect documentation. They were also facing technical issues including lack of integration between different systems, limited reports that were not easy to read and poor analytical capability. The application did not provide any workflow, collaboration, notification or alerting capabilities.

    The company selected the MetricStream solution to automate the document and case management and review processes. The solution’s off-the-shelf features and configurability was used to meet specific business requirements. The solution has provided benefits like:

    • Global users can access the solution over the web. Powerful reporting along with executive dashboards for analytics and trending provides real-time visibility
    • The application easily integrates with other systems to provide a seamless working environment.
    • The group’s document review cycle time has gone down significantly as the automated workflows takes documents through the prescribed lifecycles without any delays
    • The quality of reviews has significantly improved reducing the risk of rejection and noncompliance

    With the MetricStream solution, the Safety and Risk Management Group has successfully adopted a proactive approach to document and case management yielding better results and significant cost savings.