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 : 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 .

Moreover , such quality issues can set off a domino effect within the healthcare ecosystem , leading to backorders , product recalls and shortages , which ultimately delay patient care .

A key strategy for tackling these challenges is the adoption of a robust document control system . This system , which is central to biopharma companies , directly influences product quality . It includes establishing SOPs , product guidelines and GMP , all under a comprehensive review and approval process . When employees are well-trained in these protocols and adhere to them , the likelihood of errors dramatically decreases . By adhering to document control procedures , employees can contribute to the consistency , safety , efficacy and quality of the products they produce .

Should there be a mishap , features such as document history and versioning within the document control software can help pinpoint the root cause , enabling companies to prevent similar instances from happening in the future . �

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• 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

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