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.
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 (www.syndicusinc.com)