Document Author drafts the product roadmap taking into account GAMP 5, enterprise security requirements and feedback gathered from current industry operators outlining problems with current workflows and beta testers at IP asset development companies, CRO's and CDMO's.
Document Author translates gap analysis into technical requirements. Stage appropriate re-entry for controlled new document version
Continuous Improvement
Process Alignment
Validation package supporting documents are drafted by Document Author, reviewed by Domain SME
Institutional Review
Independent Reviewers scrutinize the documentation package, perform gap analysis
Validation Plan
Validation Plan is drafted by Document Author, and reviewed by Technical Verification Lead
Validation Summary Report
Validation Summary Report summarizes results of the tests, reconciles Validation Plan
Field Level Verification
SOPs
MBRs
SOPs are drafted by author, and reviewed by Technical Verification Lead
MBRs for test execution are drafted from approved SOPs and reviewed by Technical Verification LeadTests are executed as EBRs and reviewed by Technical Verification Lead
EBRs
Tests are executed as EBRs and reviewed by Technical Verification Lead