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Creating a control strategy and exporting an audit-ready report

0:02 - Creating a control strategy and exporting an audit ready report
0:09 - Your control strategy should not live across spreadsheets, slide decks,
0:13 - and e-mail threads.
0:15 - If it takes days to trace one change or assemble one report,
0:18 - the problem is not the strategy, it's the system.
0:21 - A control strategy is built from product and process understanding,
0:25 - but that understanding changes across development, tech transfer,
0:28 - and commercial manufacturing.
0:30 - The real question is whether your team can manage those changes with speed,
0:35 - traceability, and confidence.
0:37 - Manual control strategy work creates drag.
0:41 - Teams spend too much time collecting files, reconciling versions,
0:44 - chasing approvals, and rebuilding reports.
0:47 - Instead of reviewing risks and improving the process,
0:50 - a digital control strategy changes the workflow.
0:53 - Teams can structure process knowledge, connect QTPP, CQAs, CPPs and risk assessments,
0:58 - manage change history, and keep decisions linked across the life
1:03 - cycle.
1:04 - The result is a more repeatable, reviewable process for building and
1:07 - evolving the control strategy.
1:09 - ValGenesis iCMC brings process design, risk management, collaboration,
1:14 - and reporting into one structured platform,
1:16 - helping teams reduce manual reconstruction and keep control strategy
1:21 - documentation audit ready.
1:23 - If your team is still piecing together control strategy decisions by hand,
1:27 - it is time to change the workflow.
1:29 - See how ValGenesis iCMC helps you create a structured,
1:33 - traceable control strategy and export an audit ready report.
1:40 - Visit Valgenesis.com

Summary

Control strategy work slows down when decisions sit across spreadsheets, slide decks, and email threads. When one change takes days to trace, the system is creating the drag.

Valgenesis iCMC structures process knowledge, connects QTPP, CQAs, CPPs, and risk assessments, and keeps decisions linked across development, tech transfer, and manufacturing.

Key Takeaways

  • A control strategy needs connected product and process understanding across the lifecycle.

  • Manual work makes teams collect files, reconcile versions, chase approvals, and rebuild reports.

  • Valgenesis iCMC helps teams manage change history, link decisions, and export an audit-ready report.

Who is this for

  • CMC development leaders

  • Process development scientists and engineers

  • Technology transfer leads

  • Quality assurance teams

  • Regulatory affairs professionals

  • Manufacturing science and technology teams

  • Validation and risk management teams

Relevant Entities and Links

ICH Quality Guidelines are relevant because the content refers to product and process understanding, lifecycle control, and structured quality practices.

ICH Q8(R2) Pharmaceutical Development is relevant to QTPP, CQAs, process development, and control strategy concepts.

ICH Q9(R1) Quality Risk Management is relevant to risk assessments and risk-based decisions in control strategy work.

ICH Q10 Pharmaceutical Quality System is relevant to lifecycle management of product and process knowledge.

FDA Process Validation: General Principles and Practices is relevant to process understanding from design through commercial manufacturing.

FDA Part 11: Electronic Records; Electronic Signatures is relevant to electronic records and signatures used in regulated, audit-ready documentation.

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