Welcome

Helping You Take Your Quality to the Next Level

• Do you need someone to “translate” regulations and standards into actionable action plan to bring your company into compliance through a proven efficient and effective process?
  
  
• Are you concerned that your quality system documentation “measures up” to the requirements of the FDA, EC, or ISO standards?

Aslan Document Management Services, Inc. (ADMS) will help your company achieve your quality system compliance initiatives with expert consulting and auditing services from our staff headquartered in Upstate New York. Our expertise in medical device, pharmaceutical, and other GMP-regulated industries can help you navigate the difficult pathway to regulatory compliance. We can help you achieve a higher level of compliance with FDA QSRs, GMPs, ISO 9001, ISO 13485, CMDR, and EC IVDD regulations through our battle-tested approach.

Our team has expertise in ICH Q7, GLPs and HIPAA requirements. Call or email for an appointment today to discuss your quality system compliance needs. ADMS will provide a thorough assessment of your current quality system, conduct a gap analysis, offer recommendations, and develop a cost-effective and efficient implementation plan.

Do you need to prepare an IDE, PMA, or 510(k) submission package to the FDA for your product? ADMS can help you develop and manage the content.

Third Party Pre-Certification Assessments

• Are you working toward ISO 9001 or ISO 13485 certification for your business?

Internal, Third Party, and
Supplier Auditing

• Do you need someone who will review your organization in an unbiased, objective, independent, fair, and honest manner?

Aslan Document Management Services audits against FDA regulations (QSRs, GMPs, GLPs) and ISO quality system standards. We provide third party audits, internal quality audits, and supplier audits to help you monitor your internal systems, and your OEM and external suppliers' quality systems.

Aslan Document Management Services is located in the Rochester, Buffalo, Syracuse area in upstate NY. We service customers both locally and throughout the U.S.

Aslan Document Management Services can provide independent assessment services to help you determine your current level of compliance, and help you effectively prepare for your certification audit. Assessments are performed on a one-time basis, on demand, or as a part of your annual audit plans. We provide short-term quality system assessments for companies for targeted areas, including:

We offer several management solutions including Computhink which provide efficient and effective document and record management in a secure and safe methodology.

About Us

Aslan Document Management Services (ADMS) works with manufacturers and their suppliers, from medical device to pharmaceutical API manufacturers, from packaging providers to sterile filtration manufacturers. ADMS provides expertise in...

• Assessing your processes and quality systems
• Developing and managing process, product and quality system documentation
• Compliance with regulatory and standards agencies worldwide.

We are able to give you honest, accurate, and reliable feedback on your current system, or even help you develop or enhance your existing quality system. The smallest mistakes can cost your business money and valuable time. That's why our services are thorough, detailed, and fair. Best of all, we are proactive in our communication with our clients, and strive to provide clear and concise status updates on your project on a regular basis - keeping you informed, and taking the surprise out of the audit process.