Document Control Management in the Life Sciences Industry

Document management and control is central to an effective quality and compliance management system in the FDA-regulated life sciences and food industry. Organizations following manual and paper-based processes for managing control documents are realizing that such an approach is inefficient, costly and unsustainable. Be it SOPs, batch records, regulatory filing or quality reports, inability to manage the increasing number of documents can be a bottleneck in a growing enterprise.

In this webinar, we will review common bottlenecks and productivity issues in Document Control Management and how streamlining document management and control can help in efficiency, visibility and compliance

The presentation will cover:

Document control management requirements by FDA (in Federal, Food, Drug, and Cosmetic Act),Good Manufacturing Practices (GMP) and European Community (in ISO 13485)

Document control management for

1. Compliance with 21 CFR 820.40
2. Compliance with 21 CFR Parts 210-211
3. Compliance with ISO 13485
4. FDA Audits
5. Recording non-conformances

Maintaining a central, secure repository for efficient storage and retrieval of controlled documents

Accelerating reviews, approvals and change management with workflow-based document lifecycles

Improving communication and teamwork with parallel and sequential reviews and collaboration tools

Gaining enterprise-wide visibility into document status with measurable performance metrics

Lowering the cost of compliance with electronic documents and signatures, revision control and audit trails