Quality Systems Management
GMP requirements (2l CFR parts 210 and 211), ISO standards, and industry best practices require pharmaceutical and biotechnology manufacturers, contract research organizations, and lab services organizations to implement reliable quality management systems. FDA's Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006) calls for a "comprehensive quality systems (QS) model" which integrates various aspects of the quality, manufacturing, and risk management using a holistic approach. Similar expectations are required of other national and international regulatory bodies and health authorities.
Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices.

Hundreds of pharmaceutical and biotechnology companies have turned to NOVATEK software as their solution for quality management. NOVATEK enables your organization to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of deviations, customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, training management, document management and others.

NOVATEK provides the unique capability to manage all issues, actions, and changes in a centralized and integrated system. Automated workflow and configurable business rules ensure processes are followed, while reporting provides reliable information upon request to support decision-making and improve cycle times.

NOVATEK has been validated in over 100 pharmaceutical and biotechnology companies as a 21 CFR Part 11 compliant solution, and has enabled many of these companies remediate quality system deficiencies cited in 483s, warning letters, and consent decrees.
Benefits

• Ensure compliance with 21 CFR Part 11, 21 CFR Part 210, 211, and ISO standards
• Implement a closed-loop quality system consistent with FDA thinking and industry best practices
• Implement best-of-breed quality management while integrating to ERP and MES systems
• Maintain high quality levels while conducting manufacturing operations across outsourced sites and supply chain partners
• Reduce costs incurred by re-works, scrap, and process down times
• Increase product quality and support efforts to enhance brand equity
• Reduce cycle time and increase time to market
• Adapt quickly to manufacturing changes and reduce time-to-market

Key Advantages of a Quality Management System
NOVATEK provides a robust architecture to support your organization's integrated quality management needs by providing:

Risk Reduction
NOVATEK provides flexible data-drive workflow, which ensures compliance with standard operating procedures, eliminates manual, error-prone process steps, and reduces risk of deviations and noncompliance.

Integration to Key Systems
NOVATEK integrates seamlessly with other systems including ERP, Document Management, LIMS, MES and others, via its out-of-the box NOVATEK Integration Manager. Real-time access to master data, and the ability to integrate quality and manufacturing processes, such as batch release, testing, and others, enables your organization to operate more efficiently and confidently.

Reporting
NOVATEK is the only quality management software on the market that provides a suite of reporting and trending tools. User and management dashboards, ad hoc search tools, integrated reporting, and automatic email distribution of reports enable ensure visibility, streamline processes, and reduce closure cycle time.

Flexibility
The success of a company's quality management system will be determined not just by the initial implementation, but also by the company's ability to enact changes easily and seamlessly. NOVATEK is fully configurable to adapt to your company's specific business needs, providing flexibility, as well as scalability, to support changes to fields, forms, workflows, and business rules, and the ability to add future applications, without requiring any code changes.

Industry Best Practices
NOVATEK is available with a pre-packaged quality management configuration that implements best practices resulting from over 100 industry implementations. The pre-configured solution accelerates implementation, lowers cost, and reduces risk by leveraging industry best practices.

Highest ROI
Using a single vendor and a single application reduces the number of systems to manage your quality processes as well as the associated costs. In addition, errors, omissions and repeat incidents are eliminated, operations are streamlined, and manual processes are automated, further increasing investment and productivity.

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Deviations, Out of Specifications (OOS) & Investigations
An effective and compliant quality management system requires that deviations, out of specifications (OOS), errors, and other events are recorded, assessed for product impact, and investigated to determine root cause. ISO, GMP, and other quality standards present strict guidelines that require organizations to follow procedures and establish controls surrounding the deviation management and corrective and preventive action processes.

Key challenges for many companies using paper based processes, disconnected databases, or modules of an ERP system have been to ensure that events are accounted for and processed efficiently and consistently Stagnated deviations, lab investigations, and other errors delay product release and cost the organization time, as well as money, by interrupting production and distracting resources. Lack of consistency around investigation and root cause analysis processes, leave room for error, and increase the likelihood of repeat problems.

Implementing robust systems to manage deviations, investigations, and resulting corrective action processes reduces the cost of quality, improves productivity, and decreases time to market. Deviation and investigation management is an important component of the overall quality management system, and therefore requires an integrated and closed-loop approach.

NOVATEK Deviation, OOS, and Investigation Management Solutions
NOVATEK addresses these challenges and enables your organization to manage all deviations, out of specifications, and other events in a consolidated repository as part of your organization's Quality Systems Management (QSM). With NOVATEK, your organization will ensure compliance while your employees become more productive as they access records from a user friendly, web-based interface, completely eliminating paper based forms.

NOVATEK ensures zero "missing in action" deviations, improves impact assessment, and automates workflow, enabling your organization to reduce deviation cycle time and improve quality. Integration to your existing EPR and MES systems streamlines the production process to improve batch release without requiring any software customization.

Complaint Management
Pharmaceutical and biotechnology companies must record, track, and trend customer complaints according to Good Manufacturing Practices (GMPs) defined in 21 CFR Parts 210 and 211. In addition to indicating a failure in an organization's quality system, a customer complaint may also indicate that there are potential product safety issues.
Leading pharmaceutical and biotechnology companies are taking a global approach to customer complaint handling. In addition to investigating complaints, companies must also analyze them for report-ability to health authorities in the case of adverse events. Actions by the FDA have indicated that consolidated reporting of complaints and adverse events is required. As a result, companies require scalable and flexible management systems that enable them to implement complaint handling and adverse event reporting processes.

NOVATEK Customer Complaint Management Solutions
NOVATEK software enables pharmaceutical and biotechnology companies to effectively implement a global and consolidated approach to managing customer complaints and adverse event reporting. NOVATEK ensures compliance, reduces product safety risk, and streamlines workflow processes. The system integrates complaint handling and adverse event reporting into the overall quality management system, allowing users to benefit from a single interface and eliminating the need for complex and costly custom integration.

NOVATEK enables your company to centralize complaint intake from call centers, distributors, sales, and quality management functions. Integration with ERP systems such as SAP, JDE, Oracle, and others, provides direct look-up of and linking to master product information to improve accuracy and streamline operations.

NOVATEK's workflow assigns and monitors investigations and root cause analysis steps, while its escalates any complaints or adverse event reports that are significant in nature or falling behind schedule. NOVATEK also provides response letters, and supports printing and reading of bar code labels.

• Integrated CAPA Management
  NOVATEK also enables your organization to manage all related CAPAs as part of its global complaint management system enabling your company to perform consolidated trending for internal quality management functions..

Audit Management
Audits monitor critical processes, identify gaps, and stimulate companies to improve quality. An audit management system is a critical tool for the efficient management of workflow, tracking of observations and resulting corrective actions associated with company internal audits as well as with supplier audits and regulatory inspections.
Many companies have numerous auditing groups that perform dozens of types of audits. As a result, companies have a variety of systems in place, which are not integrated as part of the broader quality management and compliance management system. This results in additional costs and missed opportunities to improve quality as well as to reduce risk of regulatory compliance issues.

NOVATEK Audit Management Solutions
NOVATEK software enables companies to improve quality, reduce costs, and identify operational risks by facilitating the full lifecycle management of audits and helping to ensure that findings are resolved in a timely and effective manner.
NOVATEK enables your organization to take an integrated approach to its audit management and support all audit programs using a best practices approach.

NOVATEK is an effective tool for managing any type of audit including:

• GMP/GLP/GCP
• Business Conduct Standards
• Clinical Support Audits
• Compliance
• Computer Related System Validation Audits
• Contractor Compliance Assessment
• Internal Quality Audits
• Risk Assessments
• Internal Controls
• Contractor / Supplier / Vendor
• Third party (FDA, ISO, other health)
• Site Audits
• Pre-Clinical Studies
• Processes
• Internal Facility Projects
• Method Validation Audits
• EH&S Audits
• And others...

NOVATEK helps auditors to plan and execute audits more efficiently by providing an integrated tracking system and a powerful workflow that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response, and corrective action tracking.

NOVATEK’S unique Audit Manager standardizes audits and increases auditor efficiency by providing online questionnaires and templates, performing scoring, and empowering audit team members to download their assigned audits to document results and findings offline. Audit reports can be produced directly from the NOVATEK system eliminating time consuming paper-based processes.

Integrated CAPA Management
NOVATEK enables your organization to manage all related CAPAs as part of its global management system. CAPAs resulting from internal or external audits can be classified separately enabling segregation from CAPAs originating from other sources. As a result, each CAPA will follow a distinct workflow, providing flexibility as well as the ability to perform consolidated trending for internal quality management functions.

Change Control
Best practices and industry standards, as well as regulations imposed by regulatory bodies, require companies to demonstrate control over change management. Change control systems must ensure consistent procedures and informed decision-making by qualified individuals as well as assure traceability back to the justifications behind the change process.

Despite the economic benefits, the vast and complex nature of change control procedures has caused many companies to struggle with implementing a global change management system. As a result, many companies use a collection of disconnected manual systems, spreadsheets and databases, which results in duplicate data, data errors, and delays.

NOVATEK Change Control Solutions
NOVATEK software enables companies to improve efficiency, increase control, and reduce defects as a result of implementing a cohesive change control program, which integrates with other components of the quality management system. NOVATEK is the only solution designed to be flexible enough to manage all types of change using one centralized system.

• Equipment
• Process
• Batch/Material/Part
• Documents (SOPs, Protocols)
• Computer Systems
• Supplier changes
• Emergency Changes
• Labeling & Packaging
• EH&S Changes
• Utilities
• Validation
• And others...

NOVATEK provides your organization with enforcement of standardized change control procedures, while also allowing flexibility to meet specific workflow steps based on the type of change. NOVATEK's workflow routes change control records through the applicable impact assessment, review, approval, and implementation stages based on specific details of the change. NOVATEK ensures appropriate parties are notified of proposed changes, assigns necessary tasks, and automatically schedules approvals based on change type, impact, priority, and any other criteria.

NOVATEK integrates with ERP, equipment inventory, MES systems, and other systems to retrieve mater data. IT also provides direct integration with document management systems enabling users to link content objects, check objects in or out, and review all relevant document history.

In addition to managing the change control process, NOVATEK enables your organization to manage all related tasks and actions that are involved with the change, including impact assessments, implementation items, regulatory notifications or approvals, and post implementation actions, such as stability studies or effectiveness checks.
Corrective and Preventive Action Tracking Software (CAPA)
Corrective Action and Preventive Action (CAPA) management is the main hub of an organization's quality management system (QMS). FDA, ISO, EMEA, and other regulations and standards expect a systematic approach to managing CAPAs. Organizations must log events and problems, investigate them to determine root cause, propose corrective and preventive action plans, track and manage individual actions, and measure effectiveness to ensure the root cause has been eliminated.

Managing a CAPA program as part of the broader quality management system improves the tracking and trending of key quality drivers and resulting actions. While many organizations strive to implement this approach, only those with an effective quality management software system that implements a holistic CAPA approach are able to truly do so.

NOVATEK Corrective & Preventive Actions (CAPA Solutions)
NOVATEK software enables companies to improve quality, reduce costs, and meet compliance requirements by automating and centralizing the CAPA process using an integrated approach. NOVATEK manages CAPAs originating from any source, and enables organizations to integrate and relate investigation and corrective action processes.
The flexible NOVATEK architecture enables your organization to log any problem and manage all related investigation tasks and actions. Investigation "tasks" are assigned to investigators who access and update them from their personalized dashboards. NOVATEK improves the collaboration process by enabling investigation teams to share results and use drill-down selection tools to walk through root cause analysis steps. Electronic workflow management controls the process and improves timeliness of all CAPA plan development, approval, implementation, verification and effectiveness.
NOVATEK monitors key milestone dates to ensure investigations and CAPAs are closed on time and escalates latent issues based on simple to complex conditional logic. The system also improves the reporting and trending processes with built-in, easy-to-use search tools and integrated reporting that provides managers the critical quality information necessary to make confident GMP decisions.

Training Management
Assurance that employees are appropriately trained is an integral part of an organization's quality management system. Unfortunately, managing training requirements is a labor intensive and error prone process. Mismanagement can lead to compliance challenges and deviations.

Companies need to know that their employees are performing functions in accordance with their qualifications and according to procedures and industry regulations. This requires a structured training management system that enables systematic training assignment and follow-up.

NOVATEK Process Management Software
NOVATEK quality management software and the NOVATEK Training Manager enable your organization to reduce risk and increase employee productivity by improving management of corporate-wide training policies and requirements. NOVATEK provides a centralized, fully-automated, and electronic training management software system that enables your company to improve control over its operations.

As part of the NOVATEK platform, training tracking and reporting are performed in the same NOVATEK interface as other quality and regulatory compliance functions such as CAPA, change control, audit, and customer complaints.

Key Functionality

• Curriculum Management: Using NOVATEK Training Manager, your organization can define training curriculum and related training requirements, including classes, SOPs, and other topics that must be completed to satisfy each requisite for any job function or role.
• Automated Scheduling: Training records are automatically created in the NOVATEK system for an employee when he or she is hired, when training is about to expire, or when a change, such as an SOP change requires re-training.
• Integrated Training Workflow and Tracking: Employees access their training requirements from a user friendly dashboard and are notified when training is required and before expiration.
• Escalation: When training requirements are not completed on time, the employee, management, and quality assurance may be notified based on a pre-defined and fully configurable escalation path.
• Integrated CAPA and Change Control: Affected training requirements may be specified when processing CAPA and change control records. The NOVATEK Training Manager automatically creates new training records and assigns them to employees based on their job function when the CAPA or change control has been approved.
• Assured compliance: Managers can easily identify the team members that are in danger of falling out of compliance with training requirements using on-line dashboards and easy-to-use search tools.

Document Management
Document management and document control are important parts of an organization's quality operations. Good Manufacturing Practices (GMP), FDA regulations, ISO requirements and other governing regulations and standards require that companies manage document versions, control which documents are available to employees, and ensure that appropriate change control procedures are followed when revising documents.
Many organizations employ a conglomeration of systems ranging from manual processes to legacy or point solutions. As a result, companies struggle to achieve a collaborative and controlled work environment. Many incur high costs related to managing documents and other content while concurrently facing compliance and operational risks.

NOVATEK Document Management Solutions
NOVATEK enables companies to reduce costs of compliance and increase control over their operations by providing globally scalable solutions for fully integrated Quality Management Systems (QMS) and Electronic Document Management Systems. The NOVATEK Document Management™ solution provides companies in quality management environments with a comprehensive document management system.

NOVATEK enables employees to access controlled documents and perform all lifecycle management activities from an integrated NOVATEK system. The NOVATEK solution reduces costs and increases productivity by presenting a consolidated system for all quality management and document management needs, while allowing organizations to use best-in-class software for both functions.

Document Management Applications

• SOPs, policies, work instructions
• Batch records
• Certificates of Analysis (COAs)
• Regulatory submissions
• Regulatory correspondence
• CAPA objective evidence
• Documentation related to change control
• Validation documentation
• Manuals, instructions
• Employee training and qualification records
• Project documentation
• Investigation documents, photographs, etc.
• Contractor batch records, quality records
• Audit reports and follow-ups
• Many others...
  

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