RESEARCH THERAPY
CONTROLLED DOCUMENT MANAGEMENT WHITEPAPER
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Predicted to reach a market value of US $ 44.72 billion by 2030, document control solutions undeniably play a crucial role in the pharma and biopharma industries. They manage fundamental operational processes that facilitate drug development, maintain regulatory compliance and ensure product quality. In the pharmaceutical industry, document control systems provide a robust framework for managing and organising critical documentation throughout the product lifecycle.
These systems are designed to ensure compliance with regulatory standards such as good manufacturing practices( GMP) and good documentation practices( GDP). In the highly regulated sector, where precision and accuracy are paramount, document control systems help companies maintain version control, track changes and establish a secure and auditable repository for essential documents.
By centralising and streamlining document management processes, these systems foster collaboration, mitigate the risk of errors and expedite regulatory submissions.
Ultimately, document control systems contribute to the integrity of pharmaceutical operations, supporting the industry’ s commitment to producing safe, high-quality products that meet stringent regulatory standards.
THE IMPORTANCE OF REGULATORY COMPLIANCE
Document control is essential for biopharma companies to stay compliant with various regulatory and legal requirements. According to research by Deloitte, pharma companies tend to be behind other industries when it comes to adopting technology for compliance, such as document control software.
Document control systems often include audit trails that record changes made to documents, detailing who made what changes and when. This transparency is crucial for demonstrating compliance during regulatory inspections and audits. It not only helps make regulatory audits efficient, but also helps build stronger relationships with regulatory bodies.
To stay compliant with regulations, document control systems also incorporate archival systems that can be customised to meet retention rules.
Staying compliant is not merely about ticking off regulatory requirements – it is also beneficial for your organisation.
Beyond fulfilling obligations, regulatory compliance also offers your company advantages, such as:
• Future-proofing your company by staying in step with and even ahead of, legal and regulatory changes and updates.
• Accelerating progress and increasing efficiency and productivity as document control establishes standardised procedures for creating, reviewing, approving and updating documents. This consistent approach ensures that all documentation, including SOPs, protocols and reports, follow a uniform format and meet regulatory expectations.
• Reducing risks and cutting down on errors through appropriate access, required electronic signatures and audit trails.
MAINTAINING PRODUCT QUALITY AND SAFEGUARDING PATIENT SAFETY
In 2023, manufacturing quality issues were the primary source of pharma supply chain disruptions and drug shortages in the United States.
It became evident that product quality doesn’ t just shape a company’ s reputation – it also directly impacts patient health. �
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