Please click on the challenge summary to go to the detailed QA Edge solution.
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Challenge Details
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C1
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We need to hire Computer Validation experts now in order to complete a critical systems project.
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Solution: QA Edge can immediately find and supply validation consultants who have experience with a wide variety of regulated systems. These consultants can rapidly collect information and author and/or review any and all validation deliverables (see list above). The objectives of these documents are to move the project along, manage risk, and provide valuable feedback on the true status of the project. Ultimately, the documents will be used to tell the story that the project is under control.
For information on the consultants we can place for you, click here.
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C2
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Our QA function is backed up and we need staff to review and independently approve that the Computer Validation deliverables produced for a project are in full compliance with company SOPs and that there are no violations of good documentation practices or other FDA expectations.
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Solution: QA Edge can supply consultants on a full-time or on-demand basis to review project deliverables, provide consistent feedback, and sign-off on acceptable documents.
Our consultants can become a member of a project team providing answers to Computer Validation questions and guiding efficient production of the computer validation deliverables.
For detailed consultant descriptions, click here.
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C3
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We need to learn more about risk-based approaches to Computer Validation.
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Solution: QA Edge can deliver a one-day training workshop on applying risk-based thinking to Computer Validation. This course will give the participants the current thinking from FDA, explore the aspects of regulatory, safety, and project risk and examine potential risk mitigation strategies.
This course can be delivered for a project team at the start of the project in order to complete the risk assessment and provide valuable input into the validation and risk management plans.
For information on our Risk-Based Approach to Computer Validation training, click here.
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C4
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We’re implementing TrackWise® (from Sparta Systems) for tracking Corrective Action Preventative Action (CAPA) investigations, or Change Control, and we need an efficient approach for validation.
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Solution: QA Edge can supply experienced TrackWise® validation experts. QA Edge is a recognized validation partner of Sparta Systems and has passed their stringent certification requirements. We have significant experience validating TrackWise® at a number of large pharmaceutical clients.
For more information on our TrackWise validation experience, click here.
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C5
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We want to lower our current computer validation costs and get more value.
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Solution: QA Edge can supply consultants on a long-term staff augmentation basis with rates lower than for project staff. These consultants have been trained to employ Computer Validation best practices which focus on helping project teams deliver the promised value on time. They roll on and off multiple projects and provide a continuity of message and standards within the client.
QA Edge can also supply senior consultants to review current Computer Validation policies, procedures, and organizational structures to identify bottlenecks and opportunities for improvement and cost reduction.
For information on the consultants we can place for you, click here.
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C6
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As a vendor, we want to increase credibility in the pharma marketplace and be prepared for audits.
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Solution: QA Edge can work with vendors in a number of areas including performing “friendly” audits, writing independent software quality assurance reports, supporting them before, during and after audits, and performing product certifications for 21 CFR Part 11. QA Edge can develop fast-track validation packages that can be sold with the product to provide a competitive advantage. The product validation package enables the vendor’s client to quickly validate the product which lowers their total cost of acquisition.
QA Edge can also help the vendor with closing sales, handling validation objections, and partnering on the solution implementation and validation at the client site.
For information on our auditing training, click here.
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C7
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We need a comprehensive training program that is going to teach us “best practices” for doing Computer Validation that gives us methods we can use immediately.
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Solution: QA Edge offers a three (3) day course Risk-Based Approach to Computer Validation which trains the participants on all of the aspects of Computer Validation and on how to complete the deliverables in an efficient and effective manner.
For more information on our Risk-Based Approach to Computer Validation course, click here.
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C8
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We have limited resources but we need to increase our skills in Computer Validation.
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Solution: QA Edge offers a number of products for do-it-yourself Computer Validation including the book, Computer Validation: The 100 Worst Mistakes You Can Make, by Tamara Follett. This inexpensive book ($100) will more than recover your investment by helping the reader avoid the biggest validation mistakes.
For more information on our “do-it-yourself” compliance products, click here.
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C9
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We need to improve our level of compliance in our infrastructure but we’re not sure where to start and what should be in scope.
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Solution: QA Edge can supply an Infrastructure Qualification expert to analyze the current situation, make remediation suggestions, incorporate accepted recommendations into a compliance plan, and help with the execution of this plan. Execution could include the creation of SOPs, training, and execution of IQ/OQ protocols.
For more information on our Computer Validation experience, click here.
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C10
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Our level of control for SAP changes is minimal which has caused problems for the business and increased our costs.
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Solution: QA Edge can recommend an effective SAP change control process that works in FDA-regulated environments and supply cost-effective staffing to execute testing and revalidation.
In addition, QA Edge can offer Rev-Trac®, a change control solution integrated with SAP, to manage the execution of the change and compliance requirements completely on-line with electronic signatures.
For more information on our SAP change control solutions, click here.
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C11
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We want to buy a software package from a vendor but we don’t know about their quality.
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Solution: QA Edge can perform an independent software quality assurance audit of the vendor. This evaluation can be done in person or by phone. The evaluation will cover the vendor’s state of control over design, testing and customer support. A report will be issued listing the observations and any potential risks in dealing with the vendor.
For more information on our Software Quality Support Program, click here.
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C12
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We have a large inventory of systems that have either not been validated or are only partially validated, and we need a fast track approach to bringing them into compliance.
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Solution: QA Edge has a defined methodology for rapid legacy system validation that takes advantage of using a “Fitness for Purpose” report to quickly declare that the system should remain in production. This approach is superior and less costly than trying to force-fit standard lifecycle activities to validate the system.
For more information on our “Fit for Purpose” program, call us at 800.459.3363, Ext 28.
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C13
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We have a large inventory of regulated MS Excel® spreadsheet and MS Access® database programs that are not compliant and we don’t want remediation to cost a fortune.
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Solution: QA Edge has defined technical and procedural solutions to help rapidly enable compliance of MS Excel® spreadsheets and MS Access® databases with FDA expectations.
For more information on our Excel and Access validation efforts, call us at 800.459.3363, Ext 28.
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C14
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We have formed a project team for implementing a regulated system, but we are not sure what tasks need to be added to the validation plan.
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Solution: QA Edge can fast-track your validation planning by analyzing your validation procedures, facilitating a risk assessment and identification exercise, and contributing to production of a work breakdown structure resulting in the production of a realistic validation plan that calls for the appropriate amount of work and no more.
For more information on our “Fit for Purpose” program, call us at 800-459.3363, Ext. 28.
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C15
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We would like to incorporate automated testing into our regulated projects.
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Solution: QA Edge can help integrate automated testing into the validation process and can supply testers who are experts at using the tools for maximum benefit. Our main expertise is with the Mercury and Rational suites of tools.
For more information on our validation experience, click here.
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C16
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We just had a bad inspection and we need to rapidly respond and resolve the deficiencies.
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Solution: QA Edge can help you form a response team and develop tactics for resolving the issues. Key will be describing to the regulator the strategy for removing the root cause of the deficiency to prevent its occurrence in the future throughout the organization.
For more information on our “Fit for Purpose” program, call us at 800-459.3363, Ext. 28.
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C17
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We need SOPs for Computer Validation deliverables.
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Solution: QA Edge can begin with our standard SOPs and templates and integrate them into your organization in a manner appropriate for the level of maturity desired. We have constructed Computer Validation SOPs for large and small clients.
For more information on our validation experience, click here.
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C18
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We would like to benchmark our computer validation processes against industry best practices and current FDA expectations.
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Solution: QA Edge can review your procedures, audit validation deliverables, and identify inefficiencies. Recommendations will be offered for employing risk-based principles and industry Good System Practices (e.g. GAMP).
For information on our Risk-Based Approach to Computer Validation training, click here.
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C19
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We just validated our system but we need to know that it was done correctly.
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Solution: QA Edge can audit a project at any point, including completion, to determine if there are any compliance gaps. This audit will simulate an in-depth FDA inspection. If desired, QA Edge can write the validation report as an independent reviewer.
For more information on our “Fit for Purpose” program, call us at 800-459.3363, Ext. 28.
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C20
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We just did an audit of a key supplier (e.g. software supplier, core lab, or CRO) and it didn’t go well but we really need to use them.
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Solution: QA Edge has significant experience helping sponsors provide rapid remediation services to key suppliers, especially when there are critical deadlines such as the start of a clinical trial.
For information on our auditing training, click here.
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C21
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We have formed a project team for implementing a regulated system but lack a good project manager.
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Solution: QA Edge can supply a professional project manager who is experienced with all aspects of systems delivery including compliance. The project manager will possess leadership and communication skills to manage execution of the project, coaching of team members, and ongoing reporting to the stakeholders.
For information on the consultants we can place for you, click here.
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