Pittsburgh Technical Council

Bolstered by new approach and capabilities, Syndicus wins new business

Bolstered by new approach and capabilities, Syndicus wins new business

Article Published: July 18, 2014

The strength of the Syndicus Center of Excellence (CoE) approach and Good Pharmaceutical Practices (GXP) capabilities recently resulted in new work with a large, leading medical device and pharmaceutical firm. Lab remediation work will be performed by the Syndicus Life Sciences Solutions practice in Italy, India and various U.S. locations.

The scope includes coaching and mentoring the client’s lab personnel in the following activities:

  • Assessing, executing tools, reviewing and approving their use according to Part 11 and Annex 11.
  • Specifying application and system remediation plans and change controls.
  • Updating validation deliverables, requirements and test cases.
  • Approving documentation.
  • Modifying or creating standard operating procedures (SOPs) to meet Part 11 and Annex 11 gaps.
  • Executing new test cases to validate systems and prove compliance.
  • Re-executing Part 11 and Annex 11 assessments to ensure systems meet regulations via traceability matrices.
  • Summarizing validation efforts and closing out changes for change control

Says Michael McNees, Syndicus President & CEO: “This project allows Syndicus to provide compliance leadership to help our client apply good laboratory practices (GLP) and to demonstrate effectively that their processes meet international product quality and regulatory requirements.”

About Syndicus, Inc.

Syndicus was established in 2007 in Annapolis, Md., as a technical recruiting and staffing company. In 2009, the company expanded its services to include staffing and solutions. Our focus areas for consulting are Health IT, Life Sciences and Technology Services, especially cyber security resources.

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