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21.10.2013
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. This set of ITIL templates (ITIL document templates) can be used as checklists for defining ITIL process outputs. During the process of updating the ITIL Process Map to ITIL V3 2011 Edition, we also aligned our set of free ITIL templates and checklists to ITIL 2011. There are now 102 checklists contained in our ITIL-2011-compliant Reference Process Model, and we make the most sought-after ITIL templates available for you in our ITIL Wiki.


An "Incident" is defined as an unplanned interruption or reduction in quality of an IT service.
The Incident Record template explains the structure of the data typically contained in an Incident Record. The Service Portfolio represents a complete list of the services managed by the service provider.
Content is available under Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Germany License unless otherwise noted.
Perform Integrated Change Control is the process of reviewing all change requests, approving changes, and manage changes to the deliverables, organizational process assets, project documents, and the project management plan. You can buy each template individually or purchase the Perform Integrated Change Control Package for 72% Off. The purpose of this document is to provide a description of practices for change management for projects. This is the worksheet where you can record the project changes including their priorities and status. This template is the change request to be implemented and submitted to the change control board or decision making group. This template is a worksheet where you can record the project changes including their priorities and status.
This template is the identification of projects elements affected by a proposed change request. This is a complete change management plan that will ensure all project changes are reviewed and approved in advance across the entire project. This template includes an initial review, impact analysis and results for the requested change.
In this template you can log the changes in your project including price, priority, and target closing date. This change register worksheet helps you to register and organize all changes in your project. Watch our presntation videos to know the best Project Management tips developed by Senior Project Managers. Do NOT purchase goods from sellers who ask for offline payment methods!If this listing violates your intellectual property rights, please contact us and we will take it down.
Change Management Plan template to address changes which may be encountered during the project lifecycle. CMP template to: Define the process, tools, and stakeholders that will be used to manage any changes to the project. This makes for a fascinating course, where you learn so much more than the words on the page.
Melanie is the most brilliant, sharpest and entertaining trainer I've ever had the pleasure to meet.
She immediately perceives the functioning of any organisation and her vast experience inspires trust and respect. She challenges you to really think about your own experience in order to embed the learning. Melanie is clearly an expert in this field and not only helped us to learn and understand the theory of change management but also gave us lots of examples of how she has worked with the models in practice.
Melanie Franklin, the international expert in Change Management, has driven the skills and expertise in Change Management and Project  Management for over 20 years. Melanie’s background in Operational Management for international banks led her to develop her interest in the benefit of evidencing skills through accredited qualifications. While it certainly helps, the thing that delegates say course after course is that it is her real-world experience that brings the material to life. Combining Agile Project Management with Change Management came about from the global financial crisis starting 2008. Creating Agile Environments has been a theme for Melanie Franklin and her e-Book of the same title showed readers how to move from a traditional Waterfall project method such as PRINCE2 towards a more Agile approach.
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. The ITIL templates can also serve as guidelines which are helpful during process execution. At the same time we took the opportunity to revise and enhance the ITIL document templates, taking into account customer feedback on the V3 versions.
These ready-to-use templates and checklists are also a good starting point for designing ISO 20000 compliant documents and records.
The details of an Incident and its complete history from registration to resolution are recorded in an Incident Record. You can use this checklist as a template when you start creating Incident Records in your own organization.
It contains present contractual commitments, new service development, and retired services. An RFC, specifying the details of a proposed Change, must be submitted to Change Management for every non-standard Change. It highlights which information is typically held in the Configuration Management System (CMS) or in Configuration Management Databases (CMDBs) to describe Configuration Items (CIs).
It can be applied to any project regardless of the business, customer, solution, or approach.
Not only did she cover the project management course material to a tee, she also enriched it with real-life examples. Anyone looking to find Change Management experts will see that Melanie has dedicated the last 15 years to building both certificated Foundation & Practitioner qualifications in project management and also practical workshops in applying the concepts to the real world. Through this platform, she delivers accredited training courses in Change Management and Agile Project Management at both the Foundation and Practitioner levels. Originally through PRINCE2, she went on to build the 5th largest project management training company offering expertise and training in project, programme, risk and change management with delivery ranging from Asia to Africa and the Americas. Aside from her time running global operations within investment banking, she continues to deliver expert Change Management consulting to large companies and international agencies. As there became less money to spend on projects and staff, traditional waterfall methods of delivering projects came under pressure and started to rely more heavily on the ability of leaders to communicate change but also the willingness of staff to think in a more agile way. As the previous decade in the UK had been driven by government spending on PRINCE2 training and methods, moving organisations away from a prescriptive approach to one where incremental delivery of benefits was required was going to take time. As an inspiration speaker, she provides key-note talks at conferences, runs regular webinars on technical aspects of change and agile project management and writes regular blogs and white papers on the issues facing leaders and staff within organisations going through change. She was sought out for this role due to her limitless energy as well as in-depth practical experience as a Change Expert. 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. I love Mel's ability to read a room, to adapt to whatever she is presented with and her ability to make the complex simple. Every 4-6 weeks, Melanie delivers the UK open course schedule in her Central London venue, just a few minutes’ walk from Bank, Cannon Street, London Bridge and Liverpool Street. Core to her belief was that while systems and processes greatly enhance the ability or organisations to deliver projects, there was a lack of focus on change management, leadership and behavioural skills. Her work ranges from one-off assignments aimed at redefining corporate strategy to running a series of workshops for those involved in a Change programme to being the lead consultant on a multi-billion dollar transformation programme.
After extensive research with industry leaders in the public, private and third sectors, Melanie wrote her award winning book “Managing Business Transformation” and the associated Tool Kit.
However as financial constraints continue to bite in the UK public sector in particular, innovative thinking to deliver new benefits faster and for less money becomes ever more necessary. Her expertise in these areas is much in demand however she is able to balance her time to ensure all that work with her come away with the benefits they sought. Working with her UK committee, she is raising the level of debate around the issues of Change Management and creating a new generation of professionals that can call themselves Change Consultants. 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. Combining her skills in both subjects with a highly practical, engaging and high-energy delivery style, 100% of delegates come away satisfied, knowing that their investment in money and time was worth it. She championed the new Change Management qualification in 2008 and did the same with Agile Project Management in 2010.
Each of these assignments provide the opportunity to test and analyse the effectiveness of the principles of Change Management and then feed this back to delegates attending her accredited courses help in London. As such, hardly a week goes by without Melanie receiving and enquiry from a UK local authority, central government office or the NHS for help speed up project delivery. This continuous feedback loop has enabled Melanie make significant contributions to the new Change Management syllabus launched in May 2015 both in terms of editing the Effective Change Manager’s Handbook course manual as well as assuring the new examination syllabus.
Combining a structured approach to change with the benefits of Agile Project delivery, Melanie was able to include anecdotes drawn from her experience as a Change and Agile consultant.



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