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05.12.2015
AssurX’s Change Management Software is a flexible, centralized system used to orchestrate, track and document changes across all functional areas of a business. With easy, full integration to other quality related processes such as corrective action management, audits, nonconformance, customer complaints, document management, training, etc., no matter where an issue triggering a change originates, or how many departments a planned change touches, the system effectively controls the process. The AssurX Change Management system receives any type of proposed change and efficiently manages evaluation, planning, implementation and documentation across every part of your operation—all in a closed-loop workflow.
A system of automatic escalation, notices and reminders integrated with e-mail can be easily defined and keeps the process moving to prevent issues and tasks from falling through the cracks. Unlike other systems that rely on third party tools to generate reports and metrics, AssurX comes with user-configurable built-in dashboards, metrics and ad-hoc query functionality that allows for real time monitoring, trending and analysis.
The system combines centralized control of the process with integrated collaboration, review and approvals from designated Subject Matter Experts.
For FDA regulated companies, AssurX is fully compliant with 21 CFR Part 11 and Part 820, GMP, ISO and more.
With its highly configurable workflows, AssurX is the only vendor that provides a solution flexible enough to manage any type of change across all functional areas. Simple point-and-click configuration of workflows, fields, forms, rules, lists, signatures, etc. OnDemand (Software-as-a-Service) option gets you up and running in days with no hardware or software to install and no waiting for IT staff. Its true zero-client architecture (CATSWeb) means AssurX runs on all browsers and operating systems with no need to install, upgrade, validate or manage client computers. AssurX Change Management integrates easily with external business systems like ERP, PLM, CRM, LIMS and MES solutions to connect all quality related processes and procedures across the enterprise—so change requests triggered from any source can be immediately captured and acted upon. AssurX’s system of quality and compliance software solutions is designed to be simple to use, maintain and configure to meet each business’ precise needs. IPM makes Contract Management easy with better access to project data, quick links to contract information and a streamlined process that optimises the letting of a contract. Create, manage and send Change Order and Change Request documents from within a single environment.
Usesearch functionality to locate previous email communications with subcontractors, clarifying any discrepancies. Record detailed information about each Change Request in the one form, from estimates and mark-ups to Subcontract Change Order Price Requests. In order to comply with cGMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books, etc.
21CFR part 11 requires that all systems that govern any cGXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated. Current Good Manufacturing Practices (cGMP) are mandated by the FDA to ensure that the products manufactured by the industries such as pharmaceutical, biotech and medical devices, meet specific requirements for identity, strength, quality, and purity. Hence, 21 CFR Part 11 also specifies a number of requirements for software systems to enable trustworthy and reliable electronic records and signatures - see Figure 1. Validation is the process of compiling written verification of all system functions and the performance of those functions to system specifications, as well as data integrity and system maintenance. The FDA’s General Principles of Software Validation - “Final Guidance for Industry and FDA Staff”, published jointly by CDRH and CBER was originally written with the medical device industry as its intended audience. This guidance is now being held up to the rest of the FDA-regulated world as an example of best practices in computer system validation. While various consulting companies have created their own methodologies for systems validation, our experience shows the following framework to be the comprehensive and applies to both -off-the-shelf software or home grown. All system requirements must be clearly defined and approved before any design or coding effort starts. Multi-level testing methodology including unit test, functional test, integration test and system test must be followed. Closed-loop change control: This element ensures that proper change control documentation, approval and testing procedures are followed for any changes including, correcting software defects or adding new capabilities for a new version of the software or making changes to software configuration. Organizations that implement this framework find it easier to keep their system FDA validated on an ongoing basis. In a world where technology and business practices are dynamic rather than static, reactive compliance audit methodologies provide questionable value.
MetricStream is a market leader in Enterprise-wide Compliance and Quality Management software for global corporations.
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. 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 provides the unique capability to manage all issues, actions, and changes in a centralized and integrated system. 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. 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. NOVATEK integrates seamlessly with other systems including ERP, Document Management, LIMS, MES and others, via its out-of-the box NOVATEK Integration Manager. NOVATEK is the only quality management software on the market that provides a suite of reporting and trending tools. 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 available with a pre-packaged quality management configuration that implements best practices resulting from over 100 industry implementations. Using a single vendor and a single application reduces the number of systems to manage your quality processes as well as the associated costs. 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.
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.
Implementing robust systems to manage deviations, investigations, and resulting corrective action processes reduces the cost of quality, improves productivity, and decreases time to market. 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).
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. Leading pharmaceutical and biotechnology companies are taking a global approach to customer complaint handling. NOVATEK software enables pharmaceutical and biotechnology companies to effectively implement a global and consolidated approach to managing customer complaints and adverse event reporting. NOVATEK enables your company to centralize complaint intake from call centers, distributors, sales, and quality management functions. 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 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.. Audits monitor critical processes, identify gaps, and stimulate companies to improve quality.
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 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.
NOVATEK enables your organization to manage all related CAPAs as part of its global management system. Best practices and industry standards, as well as regulations imposed by regulatory bodies, require companies to demonstrate control over change management. 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. 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 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 integrates with ERP, equipment inventory, MES systems, and other systems to retrieve mater data. 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 Action and Preventive Action (CAPA) management is the main hub of an organization's quality management system (QMS).
Managing a CAPA program as part of the broader quality management system improves the tracking and trending of key quality drivers and resulting actions. NOVATEK software enables companies to improve quality, reduce costs, and meet compliance requirements by automating and centralizing the CAPA process using an integrated approach.
The flexible NOVATEK architecture enables your organization to log any problem and manage all related investigation tasks and actions.


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. Assurance that employees are appropriately trained is an integral part of an organization's quality management system. Companies need to know that their employees are performing functions in accordance with their qualifications and according to procedures and industry regulations.
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.
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. 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. 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 and document control are important parts of an organization's quality operations. Many organizations employ a conglomeration of systems ranging from manual processes to legacy or point 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. NOVATEK enables employees to access controlled documents and perform all lifecycle management activities from an integrated NOVATEK system.
The configuration of your SSH server determines which ciphers are used when connecting to the Stat Central Agent. Download the Change request template and instantly start creating Change request reports that are clear, detailed, and accurate. Tracks Change Requests (CRs) for defects and new features through a full Change control cycle: new, analysis, implementation, close-out. The purpose of this application is to ease the process of programming ClearQuest Designer's state transitions matrix for Change Requests. The System Center Service Manager – ExChange Connector package provides a way to connect Service Manager to ExChange for processing incoming emails related to incidents and Change Requests. Experts suggest to Change OST to PST file when user's account on ExChange Server is deleted accidently, ExChange Server gets corrupt or even when user's Outlook profile gets damaged. Mobiano Themes Box is a Free utility to Change your Pocket Pc Today Screen Themes at your desktop computer.
AVS is a Free source configuration management software, embedding a full bug tracking engine. AVS Shellext (AVS shell extension) is a Free Windows x86 AVS client, accessible through the shell explorer.
ProjectTrack was built by those people who know that any plan is 33% wrong the second it is created. The program helps IT departments with Change, incident, purchase, and dependency management. Tracking defects, issues, and feature Requests is a critical component of any software development and quality control process. Verax Trouble Ticketing is a powerful application that allows you to keep track of all the incidents from your company. Sprintometer Pro is extended version of Sprintometer which supports additionally user defined work types and any national characters for all project data. DBmaestro bring SCM benefits into the database development world by creating DBmaestro TeamWork - an award-winning Oracle Database Change Management and Version Control solution. Health Diary for iOSFree for a limited time.This is an application for recording the state of your health. Census is a highly scalable Web-based bug tracking and defect tracking tool that can also track Change Requests, support calls, test cases, timesheets, and much more. The administrative discipline of identifying the configuration of a system at discrete points in its development life cycle for the purposes of systematically controlling changes to the configuration and maintaining its integrity and traceability throughout its development life cycle. The figure depicts a typical set of these discrete points, commonly called baselines, where deliverables may be evaluated. The international software engineering community generally agrees on the role of configuration management in a software project. It creates a consistent, closed-loop method to process any change type (business process, product design, documentation, materials, packaging, line repair, etc.), even for regulated industries. Feedback on the effectiveness of proposed changes and change plans is automatically requested, tracked and monitored to ensure that changes are properly planned and will deliver the expected results, before they are rolled out across operations.
AssurX has simplified and streamlined an end-to-end workflow for processing all event intakes, reportable and non-reportable. The turnkey process is provided with documentation, setup and user guides, validation scripts, template forms and workflows, executive dashboards, and everything else needed for quick deployment. The configurable processes are designed to integrate seamlessly with each other providing a single, all-in-one solution for managing quality and compliance enterprise-wide. By utilising the Outlook® integration, project managers can create, send and receive Change Requests, Change Orders and Subcontract Change Orders all from the one location. In order to comply with cGMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.
These software requirements must be met for the resulting electronic records to comply with FDA's cGMP.
It is the establishment of documented evidence that provides a high degree of assurance that a specific process, managed by the system, will consistently yield a product meeting its predetermined specifications and quality attributes.
That written documentation must be in alignment with the industry standards and regulatory laws that guide the FDA in their evaluation and enforcement of regulatory compliance. This framework ensures that the software being deployed is most likely to be compliant with FDA requirements and will continue to sustain the compliance over time.
In addition, stress Testing and disaster recovery testing must be performed to ensure that system performance requirements are met.
Change control procedures must be written and well understood through training, to ensure compliance. The system documentation is compared to the intended use specification to identify any gaps.
Best practices call for IT organizations and software vendors to use the above framework to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues. Through a combination of a good implementation of system development lifecycle and proactive internal auditing of the software development and implementation process, companies can easily comply with the system validation requirements of 21CFR part 11 at a lower cost of compliance. 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. 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. 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. 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. 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.
The pre-configured solution accelerates implementation, lowers cost, and reduces risk by leveraging industry best practices. In addition, errors, omissions and repeat incidents are eliminated, operations are streamlined, and manual processes are automated, further increasing investment and productivity. 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.
Lack of consistency around investigation and root cause analysis processes, leave room for error, and increase the likelihood of repeat problems. Deviation and investigation management is an important component of the overall quality management system, and therefore requires an integrated and closed-loop approach. Integration to your existing EPR and MES systems streamlines the production process to improve batch release without requiring any software customization. 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. In addition to investigating complaints, companies must also analyze them for report-ability to health authorities in the case of adverse events. NOVATEK ensures compliance, reduces product safety risk, and streamlines workflow processes. 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 also provides response letters, and supports printing and reading of bar code labels. 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.


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. Audit reports can be produced directly from the NOVATEK system eliminating time consuming paper-based processes. CAPAs resulting from internal or external audits can be classified separately enabling segregation from CAPAs originating from other sources. 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.
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's workflow routes change control records through the applicable impact assessment, review, approval, and implementation stages based on specific details of the change.
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. FDA, ISO, EMEA, and other regulations and standards expect a systematic approach to managing CAPAs.
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 manages CAPAs originating from any source, and enables organizations to integrate and relate investigation and corrective action processes. 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. Unfortunately, managing training requirements is a labor intensive and error prone process. This requires a structured training management system that enables systematic training assignment and follow-up. 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. 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. As a result, companies struggle to achieve a collaborative and controlled work environment. The NOVATEK Document Management™ solution provides companies in quality management environments with a comprehensive document management 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. To enable object compare support for Oracle developer objects, a compatible version of Oracle Developer and the Forms Applet Jar Files component of the Oracle Forms product must be installed. ProjectTrack Personal Edition is an all-inclusive program that will help you execute your plan.
ProjectTrack SQL Server Edition is an all-inclusive program that will help you execute your plan. ProjectTrack Collaborative Edition is an all-inclusive program that will help you execute your plan. Using Free Change Requests Free Download crack, warez, password, serial numbers, torrent, keygen, registration codes, key generators is illegal and your business could subject you to lawsuits and leave your operating systems without patches. The configuration management function saves time and money by giving management precise visibility and therefore improved control over an evolving complex system. Specifying control points (baselines) in the development life cycle where deliverables can be evaluated and uniquely labeling all baseline components (configuration items).
Verifying the integrity of a system in terms of the degree to which it complies with its specification. Understanding the development status of baselined project deliverables at specific points in the development life cycle. Our professional services group can also perform your validation and help create your PQ based on industry best practices and the latest regulatory guidelines.
Unlimited best practices workflows can be added, and modifications to existing template workflows can be easily done with point-and-click configuration.
Risk can also be significantly reduced with built in work flow rules preventing common administrative errors associated with contract management. This white paper uses that FDA guidance as an input to define an “easy-to-implement” framework for systems validation. Historically, all such documents have been maintained on paper by companies in order to comply with FDA's cGMP. If an organization does employ electronic records and signatures, but fails to comply with these system requirements, the FDA will cite the firm for violating the underlying regulation. The ultimate goal of any system validation project is to realize and sustain compliance, while ensuring the peak performance and functionality of those systems. To successfully manage compliance, each regulated system must be proven to operate in accordance with its intended use and design, and all documentation supporting that evidence must culminate in FDA-acceptable documentation. This guidance describes how certain provisions of the medical device Quality System regulation apply to software and FDA’s current approach to evaluating a software validation system. Unauthorized changes to a validated system, even during the implementation process, can have a detrimental affect on the system integrity.
Then the system is tested against the intended use specification to identify any additional gaps. The QMS audit capabilities are used to create and track an audit checklist and its results.
Similar expectations are required of other national and international regulatory bodies and health authorities. Actions by the FDA have indicated that consolidated reporting of complaints and adverse events is required.
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.
This results in additional costs and missed opportunities to improve quality as well as to reduce risk of regulatory compliance issues. 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. 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 improves the collaboration process by enabling investigation teams to share results and use drill-down selection tools to walk through root cause analysis steps.
Many incur high costs related to managing documents and other content while concurrently facing compliance and operational risks.
To learn more see: CA Configuration Management service, True Stories from the Annals of CM. Finally, the paper identifies a best practice, which calls for IT organizations and software vendors to proactively audit their software development and implementation processes on an ongoing basis to identify and correct any systemic issues to lower the cost of compliance. Even as companies automated their production and quality processes, they were still being forced to maintain and track paper records for FDA acceptance. Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR 820.70(i).
Any major gaps are fixed using the closed-loop change control method described above and retested before the system is validated as ready for intended use.
Once issues have been identified through the internal audit process, the first step is to initiate an investigation and to properly identify the root cause of the problem. As a result, companies require scalable and flexible management systems that enable them to implement complaint handling and adverse event reporting processes. Electronic workflow management controls the process and improves timeliness of all CAPA plan development, approval, implementation, verification and effectiveness. Enforce change policies by workflow, role-based security rights and audits of any changes to the underlying business logic. All download links are direct full download from publisher sites or their selected mirrors. The code of Federal Regulations (CFR) Part 11 was implemented in 1997 to let the FDA accept electronic records and signatures in place of paper records and handwritten signatures for compliance. Hence, this requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
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The regulation outlines controls for ensuring that electronic records and signatures are trustworthy, reliable, and compatible with FDA procedures and as verifiable and traceable as their paper counterparts. In addition, computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements. When corrective actions are approved, appropriate changes are implemented in the environment through a change-control process and then the CAPA is closed out. Consider: Free Change Requests full version, full download, premium download, licensed copy. Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
By using a QMS, companies ensure that the ongoing and proactive audit and corrective action process is systematized and provides the basis for lowering the cost of compliance.



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