Streamlining Validation LLC was established in 2019. This company was started after seeing so many companies struggle with the validation process. Based on the company’s expertise in the validation process, they could have a validation team or they may be a much smaller company which uses personnel from different departments to fill the need. Resources are pulled from groups such as quality and manufacturing engineering to fill the validation role as well as their traditional roles and responsibilities. If the company has a lack of experience with validation, the groups can struggle with using validation inconsistently. This causes extended review and rewriting leading to more cost, compliance and audit risk, not taking full advantage of what validation can bring to an organization, and potential quality issues not identified in a process or product.
When used properly, validation can help companies reduce cost, reduce errors, increase product quality, and decrease time to market. It is a passion of the personnel at Streamlining Validation to help companies take full advantage of the benefits of validation. Streamlining Validation LLC has created a validation process that is consistent, complete, and efficient while still being flexible enough to meet the needs of each company.
Shannon Chan, CEO
Shannon graduated from University of California, San Diego in Bioengineering: Biotechnology. Shannon has worked for diagnostic and medical device companies for the last 9 years supporting each company through various roles including Process Engineering, Supplier Quality, New Product Quality, and Sustaining Product Quality. During that time, she has seen the challenges and cost associated with validation. Working within regulated environments, Shannon has worked efficiently within the requirements to meet the needs of the company in a competitively compliant way. She can help your company through a streamlined validation process!
Shannon has received the following certifications which have helped her understand the quality needs of the industry:
Certified Quality Engineer (CQE) – American Society for Quality (ASQ)
Certified Software Quality Engineer (CSQE) – American Society for Quality (ASQ)
Certified Supplier Quality Professional – American Society for Quality (ASQ)
Certified Lead Auditor with Emphasis on ISO 13485 – Oriel Stat A Matrix
Certified Manager of Quality/ Operational Excellence (CMQ/OE) – American Society for Quality (ASQ)