Audits |
Software
Services |
|
|
Clinical
Services |
FDA
Submissions |
Detailed Description of Services
Quality Systems, Compliance and Engineering
For pharmaceutical, medical device and OTC companies, AccuReg offers guidance and "hands on" support in the following critical compliance areas:
Internal Audit and clinical audit training
Audits are an essential quality tool for verifying compliance, good practices and progress. In addition, they are often the first step to developing an action plan in areas where "opportunities for improvement" are already known to exist.
AccuReg's standard practice is to conduct each audit with an eye to solutions. Our audits are as broad and deep as the situation warrants and your priorities dictate. After the inspection is complete, we generate a detailed written report or high-level written summary documenting our observations. Again, the scope of the report is dependent on your goals for the audit and the format that best serves those goals. All audit reports include recommendations for corrective actions. At your request, we can also help you prioritize the action items, develop a formal plan and work with your staff or vendor to implement the recommendations.
We offer:
Our software services are designed to support the compliance of medical-device software and systems, Quality System software and systems, clinical data management and analysis software and systems, product testing and manufacturing systems, and electronic records/electronic signatures systems. We are experienced in the successful development and filing of 510(k) submissions for software medical products and have worked extensively with a variety of proprietary and commercial software products to develop sound validation plans and design control processes.
Additionally, in response to the need for automated traceability to support the lifecycle of many complex and extensive software products, AccuReg is a licensed distributor of the DOORSÒ family of automated requirements management tools, manufactured by QSS, Inc. For suitable projects, we offer custom-design-control solutions that can include any combination of the following: risk analysis, requirements, design document and validation plan development, and established traceability and control through a DOORSÒ product, delivered to the client with their software license and Standard Operating Procedures for maintaining design control.
Other software services include:
AccuReg's clinical services focus on identifying and preventing or correcting problems before they impact on the quality, integrity or duration of the study. PharmDs, Ph.D.s and medical and regulatory professionals staff our clinical division. They possess extensive practical experience in industry and academia. Note: AccuReg is not a CRO or SMO, and does perform routine clinical monitoring. Our Clinical division is an auditing, design review and Quality Assurance resource.
Our bioresearch auditing services include:
Other clinical services include:
AccuReg is experienced in the preparation, critical review, assembly and filing of the following regulatory submissions for pharmaceutical and medical device products:
Our Associates can work with your team to coordinate development of entire submissions, prepare turnkey inclusions (e.g., CMC sections, data analyses, validation reports, literature summaries, etc.), or any combination of participatory services.
4400 SW 95 Avenue
Davie, Florida 33328, USA
Telephone: 954-641-6400 Fax: 954-641-6410
Email: accureg@regulatory.com
Contact webmaster
Copyright © 2005 AccuReg, Inc.
All rights reserved.
No portion of this site may be reproduced without express written consent of
AccuReg, Inc.