Efficient Document Management for Pharma Companies

The drug development process is long and tedious, often taking about seven years for clinical trials and up to ten years for research and development. A significant part of this involves pharmaceutical document management, which requires handling large volumes of critical data across all stages of drug development. Many documents are still created and registered manually, often across multiple systems.

This article explores how automation can change the status quo, transforming and streamlining document management in the pharma industry.

Want to dive deeper into document processing in general? Check out this article on Intelligent Document Processing (IDP), where our ML engineer answers FAQs, tackles challenges, and shares strategies for mastering IDP systems.

Handling a massive amount of documents

The primary reason manual pharmaceutical document management takes so long and is prone to issues is the myriad of documents in pharma: internal documents, external documents, and clinical study documents like CSR and clinical summary reports. Let's try to make sense of their meaning and determine at which stages to use them.

Internal documents

The company creates and maintains many internal documents to ensure compliance, operational efficiency, and quality assurance. As a rule, these docs are not shared with external parties.

1. Standard Operating Procedures (SOPs): Detailed guidelines for processes like manufacturing, quality control, and document management.
2. Batch records: Track production and testing of each batch to ensure traceability and compliance.
3. Employee training records: Verify staff qualifications and training on processes, equipment, and compliance.
4. Quality assurance documents: Include deviation reports, Corrective and Preventive Actions (CAPAs), and internal audits to comply with GMP standards.
5. R&D documentation: Lab notebooks, research protocols, and formulation report are critical for early-stage development.
6. Validation documents: Cover protocols and reports for process, equipment, and software validation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
7. Change control records: Document modifications to processes, equipment, or procedures, ensuring controlled and approved implementation.
8. Risk management files: Include risk assessments, Failure Mode and Effects Analysis (FMEAs), and risk control strategies.
9. Inventory records: Track materials, components, and finished products for supply chain management.
10. Environmental monitoring records: Document data on temperature, humidity, and other conditions in manufacturing and storage areas.

External documents

1. Regulatory submissions: Applications like INDs (Investigational New Drug), NDAs (New Drug Applications), and CTAs (Clinical Trial Applications).
2. Vendor agreements and contracts: Manage relationships with suppliers, manufacturers, and service providers.
3. Patient information leaflets: Provide usage and safety instructions for patients as part of marketing authorizations.
4. Regulatory inspection reports: Record findings from external audits and inspections by regulatory authorities like the FDA or EMA.
5. Pharmacovigilance reports: Include Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs).
6. Advertising and promotional materials: Submitted for pre-approval to regulators to ensure compliance with promotional guidelines.
7. Distributor and licensing agreements: Define terms for product distribution and licensing to third parties.
8. Health authority correspondence: Official communications such as inquiries, deficiency letters, and responses.
9. Certificates of Analysis (CoA): Verify that products meet quality and safety standards for regulatory compliance and distribution.
10. Publication materials: Articles, abstracts, and posters are shared in journals or conferences to disseminate findings.

Clinical study documents

Essential for conducting and reporting clinical trials, these documents ensure regulatory compliance and data integrity.

1. Clinical Study Report (CSR): Detailed analysis of clinical trial data, adhering to ICH E3 guidelines.
2. Clinical summary report: High-level summary of the CSR, focusing on key safety and efficacy findings.
3. Investigator brochures (IBs): Summarize preclinical and clinical data on investigational drugs for investigators.
4. Clinical Data Management Plans (CDMPs): Outline methods for data collection, cleaning, and analysis during clinical trials.
5. Informed Consent Forms (ICFs): Document patient consent to participate in trials, including risks and benefits.
6. Site monitoring reports: Records of site visits and evaluations to ensure compliance with trial protocols.
7. Statistical Analysis Plans (SAPs): Define methodologies for analyzing clinical trial data.
8. Protocol amendments: Document approved changes to trial protocols during the study.
9. Periodic safety reports: Provide updates on patient safety and adverse events to regulatory authorities.
10. Trial Master File (TMF): Comprehensive collection of documents required for clinical trial conduct and regulatory compliance.

Documents at key drug development stages

These documents evolve across the lifecycle of drug development.

Discovery and preclinical

At this stage, the focus is on preparing an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). The documents used are:

• Research protocols and data records: Document experimental designs and results.
• Toxicology reports: Summarize preclinical safety studies.

Clinical trials

During the clinical trial, New Drug Application (NDA) submissions are prepared. Some new documents that appear at this stage are:

• Trial protocols and site qualification reports: Define study objectives and ensure site compliance.
• Patient consent forms and investigator agreements: Ensure ethical and legal trial conduct.

Manufacturing

• Batch records and cleaning validation reports: Ensure product quality and cross-contamination control.
• Equipment maintenance logs: Track routine servicing to maintain operational standards.

Marketing authorization

• Regulatory submission dossiers: Comprehensive documentation for product approval.
• Summary of Product Characteristics (SmPC): Provide healthcare professionals with essential drug information.

Post-market surveillance

• Adverse event reports: Monitor and document drug safety after market approval.
• Periodic Benefit-Risk Evaluation Reports (PBRERs): Assess long-term product safety and efficacy.

Benefits of document management automation in pharma

Automated pharma document management solves many issues with documents, mainly the tedious and expensive generation of clinical study reports that prevent scientists from focusing more on the scientific aspects of clinical trials. Here are the main benefits detailed:

Time savings

Efficient document management automation dramatically reduces the time spent on document-related processes and improves time to market.

• Instant retrieval of adverse event reports or historical clinical trial data ensures rapid responses to regulatory queries.
• Tasks like approval processes, regulatory submissions, and report generation are streamlined with automated notifications and routing.
• Automation minimizes repetitive administrative tasks like manual data entry and formatting so scientists can focus on higher-value activities.
• Automated preparation and submission of documents in formats like eCTD make regulatory hurdles faster. Some time-consuming tasks, like manually documenting the entire clinical trial, take time away from potentially life-saving drug development. Automatic documentation speeds up FDA approval.
• AI in pharma R&D and big data analytics in pharma can speed up document retrieval and improve data integration across trials.

Improved accuracy

Automation reduces human error, which is critical in maintaining compliance and ensuring patient safety.

• Automated systems validate inputs and reduce manual errors during data entry and document updates. Textual redundancy is decreased as well.
• Version control ensures that only the latest, approved versions of documents are available.
• Automated validation checks align documents with industry standards such as FDA, EMA, or ICH guidelines.
• Comprehensive audit trails for all actions (creation, modification, and access) make documents error-proof and traceable for inspections.
• The quality is better thanks to advanced templates.
• Document automation in pharma allows us to find and quote earlier research easily.

Convenient access

Automation enhances accessibility, ensuring people can access the right documents at the right time.

• A centralized repository means all documents are stored in a single, cloud-based, or on-premise system, accessible across departments.
• Role-based access control ensures sensitive information is available only to authorized personnel.

Enhanced collaboration

Document management automation facilitates better teamwork within and across departments. Moreover, clinical trials are often carried out across multiple locations worldwide, and document automation in pharma helps ensure that no entry is missing.

• Teams can collaborate on documents in real time, reducing delays caused by manual edits and version conflicts. Any language barrier between scientists in different countries is effectively eliminated.
• Documents can be securely shared with external partners.
• Templates and consistent formatting promote uniformity across documents.

Cost efficiency

Automation leads to significant cost reductions across multiple areas.

• Accurate documentation prevents costly regulatory violations.
• Reducing delays in clinical trial documentation and regulatory reviews prevents revenue losses due to missed drug approval deadlines.

Challenges of document automation

Pharmaceutical document management challenges are inevitable whether you decide to streamline or not. Here are the common issues encountered by developers at Binariks and the best ways to solve them:

Challenge 1: Tracking and comparing multiple versions of drug documentation

Pharmaceutical documentation for a single drug may be submitted multiple times with updates. For example, a drug released in 2022 might have an update about the manufacturer in 2023 and changes regarding side effects in 2024. Tracing and comparing these versions is essential to ensure accuracy and compliance.

Solution:

• Document branching: A version tree for drug documentation allows tracking of when each version was created and viewing its details. Users can also add comments to specific versions for better context.
• Comparison module: A side-by-side comparison tool highlights changes between two document versions.
• AI-generated summaries: Automatically generate summaries of changes between document versions for quick understanding.

Challenge 2: Collaborative work on pharma documentation

Pharmaceutical documents often involve multiple contributors. For instance, someone drafts the document, others review and approve it, and translators may also be involved in multi-market releases.

Solution:

• Workflow management: Implement workflows with key steps, from drafting to final documentation.
• Task assignment and notifications: Assign tasks to users, with notification systems for tracking to-do items, overdue items, and approvals. Support for electronic signatures and 2FA enhances security.
• User roles and permissions: Define roles with specific permissions, ensuring users work only on assigned drugs rather than having access to all company projects.

Challenge 3: Error validation before regulatory submission

Errors in documentation can lead to rejections or multiple submission attempts to regulatory bodies.

Solution:

• Custom validation rules: Implement rules based on regulatory guidelines (e.g., FDA’s implementation guide) to validate documents before submission. Provide user-friendly hints to guide corrections.
• Integration with error analysis tools: Identify and resolve potential errors using existing tools.

Challenge 4: Managing complex and extensive drug documentation

Drug documentation is vast, making it easy for authors to overlook details, make errors, or mislink sections.

Solution:

• AI-powered coherency and consistency checks: Use NLP tools to ensure:
• Correct spelling and grammar.
• Accurate naming and dosage of the drug across the document.
• Logical connections between statements.
• The presence of referenced illustrations or tables.
• Valid links to correct sections (e.g., a link to Section 12 points to the correct section).

Choosing and implementing document management systems in pharma

Implementing a Document Management System (DMS) can revolutionize how documents are handled, but selecting and deploying the right system requires careful evaluation. Here's a breakdown of key considerations:

Evaluating the need for a document management system

Assessing the company's specific requirements and challenges is essential before adopting a document management system in the pharmaceutical industry.

• Does the system meet industry standards such as FDA 21 CFR Part 11, GDPR, and ICH guidelines?
• Can the system handle growing document volumes as the company expands?
• Does the organization face bottlenecks in approvals or version control?
• Is the system compatible with existing software such as ERP, LIMS, or quality management tools?

Criteria for selecting a DMS

When choosing a DMS for pharmaceutical operations, consider the following factors:

• Ensure the system supports validation and includes features like electronic signatures and audit trails.
• Make sure the system is easy to use and has intuitive interfaces and minimal learning curves.
• Choose a system that can be tailored to fit your company’s unique workflows and document types through customization.

Steps for implementing a DMS in pharma

• Engage teams from QA, regulatory affairs, IT, and operations to align goals and identify key requirements.
• Develop a strategy to transfer existing documents without compromising data integrity or losing important information.
• Validate the system to ensure it meets compliance standards and works as intended.
• Provide comprehensive training for all users.
• Conduct pilot testing before full deployment and monitor performance to identify and resolve issues early.
• After employing the system, keep it up to date to meet evolving regulatory requirements and industry best practices.
• Use the DMS to maintain accurate audit trails for inspections and regulatory reviews.

Popular document management systems for pharma

Several DMS options cater specifically to the pharmaceutical industry's needs. AI-driven tools, like AI in pharmacovigilance , enable advanced error detection and workflow optimization.

• MasterControl Document Management: Offers robust validation and collaboration tools tailored for life sciences and pharma.
• OpenText Documentum: A scalable solution with advanced security features and integration capabilities for regulated industries.
• TrackWise Digital: Combines document management with quality management.
• DocuWare: A user-friendly DMS suitable for mid-sized pharma companies, with features like secure access and mobile compatibility.

How we tackle document management challenges

Binariks leverages digital transformation in pharma and expertise in software development for pharmaceutical companies to provide scalable document management solutions.

Here is the approach to pharmaceutical document management that we apply at Binariks:

• We begin every project by assessing the client's document management challenges and goals thoroughly. We scale solutions based on the customer's specific needs.
• Here is the foundation of our approach to pharmaceutical document management software development: we always focus on complaints, ensure effective data migration, maintain workflow continuity, and make sure that interfaces are user-friendly.
• Instead of disrupting established processes, we align our solutions with the client’s operational and existing frameworks.
• Automation is a powerful tool, but we ensure manual checkpoints for critical reviews and decision-making.
• Automation is not a solution to all issues, and we do not market it as such. Our approach acknowledges that full automation is not always the answer. Instead, we focus on optimizing processes where automation adds the most value. Often, this means that document automation in pharma is targeted to specific tasks, like data migration or document approvals.
• We offer a flexible pharmaceutical document management system targeted to the scale of the business. For clients with limited data, we offer streamlined tools that are cost-effective and easy to implement, without unnecessary features. For larger organizations, we propose more comprehensive tools capable of handling vast volumes of data.

Conclusion

The drug development process relies heavily on managing vast volumes of documents across all stages, including internal, external, and clinical study records. Automation offers significant advantages, streamlining workflows, improving accuracy, and saving valuable time.

While it may not address all challenges, such as complex regulatory changes or nuanced tasks requiring human judgment (like resolving data discrepancies, ensuring contextual accuracy and ethical appropriateness, etc.), automation serves as a powerful tool when strategically implemented alongside manual expertise.

At Binariks, we understand the complexities of pharmaceutical document management and when manual expertise is required to complement automated systems. Our experts create tailored solutions that integrate seamlessly with existing tools and workflows.

By prioritizing scalability, adaptability, and compliance, your organization can harness automation to meet evolving regulatory demands, enhance operational efficiency, and support sustainable growth. With the right approach, automation becomes a key driver for innovation and success in the pharmaceutical industry.