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Integrated Quality and Compliance Management in Life Sciences Industry
A unified approach for better business performance

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Companies in pharmaceutical, biotechnology and medical devices industries are constantly pushing the boundary of innovation to develop new products. In addition, the industry is regularly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. For Life Sciences companies, regulatory requirements such as FDA GXPs, reporting mandates, international quality and safety standards and other compliance issues are evolving from isolated departmental initiatives to an enterprise level challenge.

Legacy and homegrown systems, stand-alone applications or even paper or spreadsheet based systems have been used to manage product and process quality and compliance. Such point-solutions, while designed to track product and process quality data, fail to address systemic quality problems as they lack a broad enterprise reach. Additionally, these systems do not have the mechanisms to manage by exceptions – as a result issues slip through the cracks.

Leading Life Sciences companies are taking an integrated approach to quality and compliance management
and leveraging technology and automation of key business processes to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying, tracking and resolving quality and compliance issues. MetricStream offers comprehensive quality and compliance management software solutions for managing quality programs within an organization, streamlining quality processes involving suppliers and customers and managing operational and regulatory compliance.

MetricStream Solution Capabilities

  • Non-conformance Management
  • Complaints Management
  • Incoming Inspections
  • Variance & OOS Management
  • Audits Management
  • CAR/CAPA Management
  • Documents Management
  • Equipment Calibration
  • Employee Training Management
  • Supplier Quality Management
  • Customer Quality Management
  • Cost Recovery/Charge Back
  • Product Change Notification
  • Safety & Risk Management
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    The embedded best practices for supporting key processes and requirements for standards and regulations such as ISO 9000, FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003 lower the cost of regulatory compliance and risk of noncompliance. MetricStream offers a system that supports 21CFR Part 11 compliance and streamlines key clinical, laboratory, manufacturing processes and procedures including: out-of-spec/non-conformance tracking, change control, integrated document management, electronic signatures, complaint and adverse event management and reporting on form 3500A or baseline form 3417 etc.

    Quality and Compliance: Challenges in the Life Sciences Industry
    Given the stringent regulatory environment, life sciences industries face many unique challenges. In this era of enhanced consumer awareness, increased competition and strict FDA initiatives, it is critical that companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts, and costly product recalls.

    Life sciences companies must institutionalize compliance across core processes, embrace operational excellence from the supplier’s end to the customer’s end and innovate with partners worldwide to accelerate new product and process development. Key challenges facing life sciences companies today are:

    Regulatory Compliance
    Compliance with regulations helps protect a company from risks that come from various directions. The risks of non-compliance are high. They include loss of credibility, reduced shareholder confidence, and significant adverse publicity. Even more serious for the individuals involved is the prospect of being fired, with little chance of reemployment, or in the worst case, imprisoned. For instance noncompliance with Part 11 is no longer an option for pharmaceutical companies. Warning letters and 483’s are costly to address and lead to lost customers, criminal court sanctions such as fines, personal liability of directors, managers or other responsible officers of an organization, and even prison sentences.

    Data Complexity
    Life sciences industry deals with many different types of data- from knowledge management and data systems to specialized applications for new drugs, informatics and sequencing, proteomics (protein research). Data comes from various sources and is generally found in heterogeneous, often proprietary formats that stand in the way of easy data sharing. For example the submission of the New Drug Application (NDA) requires documentation of 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. However, with multiple versions of document floating, it gets difficult to ensure that the right document has been filed at the right time.

    Challenges in the Life Sciences Industry

    Bringing a new drug to market can cost upwards of $900 million and take 10-15 years

    An estimated 85 percent of company's information assets are in "unstructured" data formats

    Delay in clinical trials costs the companies US$1 million a day for getting a drug to market

    Out of the life sciences companies surveyed, 40% said their biggest said their biggest challenge was bringing legacy system into compliance

     

    Inefficient Quality Systems
    Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. However, these systems demand tremendous man-hours in terms of routing Standard Operating Procedures (SOPs) and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections. Lack of communication and information across all branches leads to delay or inappropriate resolution of complaints and adds discrepancies in quality. The absence of visibility of operations to the top management also leads to noncompliance.

    Disconnected Processes
    Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.

    High Cost of Validation
    21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a medical device company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.

    Hinders Rapid Access
    The data retrieval process can be cumbersome when there is no regulated system. As without systematic storage, it gets difficult to collate data and derive interpretations and information. It makes it difficult for the company to benefit from its previous investment in design, development, and testing. Re-deployment of existing architectures, data services, and objects to serve new purposes takes too much time and investment of resources.

    Best in Class Solutions for Quality and Compliance
    Life Sciences organizations across the globe are turning to software systems and support that rid them of the bureaucratic burden of compliance, enabling them to meet their regulatory commitments in a streamlined manner, whilst unlocking the latent business and quality improvement opportunities within their management system MetricStream enables companies to take a risk-based approach to quality and compliance management and provides a common framework and an integrated approach to meet FDA regulations through risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions.

    MetricStream's advanced and comprehensive suite of FDA regulatory compliance software solutions for automating GXP compliance processes has embedded best practices that ensure ongoing compliance with FDA regulations. By improving operational efficiencies in quality systems, MetricStream lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality issues.

    MetricStream uniquely combines software and content to deliver FDA compliance software solutions for effective and sustainable compliance with embedded best practices templates, access to training content from an expert community, and integration of business processes with regulatory notifications or industry alerts.

    MetricStream compliance solutions are widely being used in the life science industry for supporting key processes and requirements for 21 CFR Part 11, Part 210-211, Part 820 / QSR, Part 606, ICH Q7A compliance such as:

    Closed Loop Processes
    Ensuring that all quality processes are well integrated to create a unified and seamless environment for quality related issues and data. MetricStream solution tracks events as they move from one stage to the next, even across departments and groups, to ensure a closed loop quality management process. For instance, a document change can initiate a training request and CAPAs triggered as a result of audit findings are tied to the audit.

    Streamlined Corrective Actions
    Engaging teams to collaborate on development and implementation of corrective action plans. MetricStream enables triggering CAPAs, performing root cause analysis, assigning follow up actions while effectively tracking and routing cases from initiation to closure.

    Efficient Audit Management
    Conducting frequent internal audits to ensure that the established product and processes quality requirements are being followed. MetricStream provides capabilities to efficiently plan, schedule and conduct audits, allows audit findings to be reviewed and analyzed by a team, enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to monitor the entire process.

    Implementing Document Control
    Streamlining document management and control processes for documents such as SOPs, batch records, regulatory filing, and quality reports. MetricStream enables companies to adopt an electronic and automated approach to managing and controlling documents across the enterprise with a centralized repository and tools for collaboration.

    Tracking Nonconformance and Deviation
    Accelerating nonconformance and deviation review and approval cycles with automated workflow. MetricStream supports recording and automatic rule-based routing of nonconformance issues for review, disposition, and closure.

    Real-time Reporting
    Tracking quality issue and processes in real-time on executive dashboards and reports for data driven decision- making. MetricStream provides complete visibility into quality system database with comprehensive aggregate reporting as well as individual case status tracking. Graphical executive dashboards and flexible reports with drill-down capability provide statistics, analytics and trending.
    Conclusion
    Many organizations find themselves managing their quality and compliance initiatives in silos – each initiative managed separately even if data, processes and reporting needs overlap. When systems and procedures to support these were put in place, the decisions were made in a tactical manner, without keeping the broader set of requirements in perspective. As a result, organizations have ended up with dozens of such systems, each operating in their own silo.

    Majority of Life Science organizations find themselves in this situation today. However, they are quickly finding that as the multiple quality and compliance initiatives become more intertwined from regulatory and organizational perspectives, multiple systems cause confusion due to duplicative and contradictory processes and documentation. In addition, the redundancy of work, as well as sheer expense of maintaining multiple point solutions causes the cost of compliance to spiral out of control.

    By taking an integrated approach to quality and compliance management and deploying a single system to manage the multiple initiatives across the organization, companies can achieve better business performance through improved control, definition, enforcement and monitoring of critical business processes. MetricStream's solutions for the Life Sciences industry integrate processes, reduce risks, streamlines information flows, improve operational efficiencies and help meet desired quality levels and compliance requirements thus delivering dramatic positive impact on organizations performance and effectiveness.