Pharmaceutical Document Management: Definition, Requirements, and Software

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Illustration of a Woman Holding Documents

Pharmaceutical document management refers to the systematic handling of documents in pharmaceutical companies, encompassing organization, storage, retrieval, and maintenance. The document management process ensures compliance with industry standards, guidelines, and regulations while supporting operational efficiency and accuracy.

A critical subset of document management is document control. Document control focuses on ensuring that only the most current and approved versions of documents are in use. This involves reviewing, approving, tracking, and versioning documents to maintain accuracy, regulatory compliance, and efficiency. Document control also ensures outdated versions are archived appropriately. Pharmaceutical companies utilize document control to manage their documents throughout their lifecycle.

To facilitate document management and control, pharmaceutical companies rely on Document Management Systems (DMS), which can be physical, hybrid, or electronic. Electronic DMS (eDMS) or document management software is particularly beneficial, offering secure and accessible solutions for organizing and handling critical documents and records.

Pharmaceutical companies handle several types of documents and records. Common documents include Standard Operating Procedures (SOPs), analytical test methods, and regulatory submission dossiers. Types of records include Batch Master Records (BMR), training records, equipment maintenance logs, and product release notes, among others.

Several standards, guidelines, and regulations specify the requirements for managing pharmaceutical documents and records, including ISO 9001:2015, 21 CFR Part 211, and ICH Q7, among others.

Document management software enhances these documentation processes by providing features like easy access to documentation, predefined workflows, and version control. These tools improve efficiency, maintain compliance, and ensure seamless document handling.

SimplerQMS offers QMS software with robust document management capabilities tailored for pharmaceutical companies. Book a personalized demo to see how SimplerQMS can streamline your document management processes.

What Is Pharmaceutical Document Management?

Pharmaceutical document management refers to the systematic handling of documents and records within pharmaceutical companies, ensuring their creation, review, approval, storage, retention, retrieval, and archiving are conducted accurately, securely, and in compliance with industry requirements. The document management process plays a vital role in supporting activities such as drug development, manufacturing, quality control, and compliance.

The lifecycle of pharmaceutical documents encompasses several stages, from creation and distribution to archiving and eventual disposal. Document management is a requirement in several standards, regulations, and guidelines applicable to pharmaceutical companies, such as ISO 9001:2015, 21 CFR Part 211, ICH Q7, and ICH Q10.

The primary goal of pharmaceutical document management is to maintain data integrity, traceability, and accountability for all documents and records. By implementing robust document management processes, pharmaceutical companies can ensure the secure and compliant handling of critical documentation, while enhancing operational efficiency and ensuring compliance.

What Is Document Control in the Pharmaceutical Industry?

Document control in the pharmaceutical industry refers to the process of controlling documentation throughout its lifecycle. It involves reviewing, approving, tracking, submitting, versioning, and retiring documents and records.

The purpose of document control is to ensure that documents are accessible and traceable and that only the most recent document version is in use. Effective document control ensures that employees follow the latest procedures, eliminating errors related to using outdated documents.

What Is the Difference Between Document Management and Document Control?

The difference between document management and document control lies in their scope and focus.

Document management involves storing, organizing, retrieving, and distributing documents across the company. Effective document management helps users locate, share, and create documents.

Document control involves the review, approval, tracking, and versioning of controlled documents. It ensures that only the latest approved versions are accessible while archiving outdated versions. Document control also helps employees stay informed about the status of each document.

Document management and document control are interconnected. Every controlled document is a managed document, but not all managed documents are controlled. Controlled documents rely on document management practices to exist.

The difference between document management and document control is illustrated below.

Document management is broader, encompassing the overall handling of documents.

Document control focuses specifically on ensuring compliance, accuracy, and version control of documents.

What Is the Importance of Documentation in the Pharmaceutical Industry?

Documentation is important in the pharmaceutical industry to ensure transparent, traceable, and compliant processes, decisions, and actions throughout the pharmaceutical product lifecycle.

The role of documentation in the pharmaceutical industry is to provide clear and organized documents for processes and procedures. Proper documentation supports accountability and effective communication within and between departments, ensuring consistency in operations.

Documentation provides a controlled, traceable, and accurate record of all operations and is essential for ensuring compliance with relevant requirements within a Quality Management System (QMS).

What Are the Types of Documents in the Pharmaceutical Industry?

A document is a file that is written, printed, or digital, and it provides information or instructions. A pharmaceutical document is a written or digital file that explains procedures, protocols, guidelines, or other important details used in pharmaceutical operations.

Twelve examples of types of pharmaceutical documents are listed below.

  • Quality Manual
  • Standard Operating Procedures (SOPs)
  • Work Instruction
  • Analytical Test Methods
  • Personnel Files
  • Equipment Manual
  • Safety Data Sheets (SDS) / Material Safety Data Sheets (MSDS)
  • Supplier Qualification
  • Inventory Control Documents
  • Certificate of Analysis (CoA)
  • Risk Management Plans
  • Regulatory Submission Dossiers
Documents in the pharmaceutical industry

Quality Manual

A quality manual is a document that outlines the company’s overall quality management system and how its processes interact. In the pharmaceutical industry, this document serves as a foundational reference that ensures all QMS processes align with standards, guidelines, and regulations.

Standard Operating Procedures (SOPs)

Standard operating procedures (SOPs) are documents that provide directions on how to perform specific processes. These SOPs are used by pharmaceutical companies to ensure consistency and compliance in the execution of tasks.

Work Instruction

A work instruction is a document that details the precise instructions on how to perform specific tasks. In the pharmaceutical industry, ensure that tasks are carried out precisely and consistently.

Analytical Test Methods

Analytical test methods specify how to test the quality, strength, and purity of pharmaceutical products. These analytical test methods are used in pharmaceutical companies to verify that products comply with all relevant requirements before reaching the market.

Personnel Files

Personnel files are documents that contain information on employee qualifications, training, and performance. In the pharmaceutical industry, these files are used to maintain a record of employee information, including qualifications, training, performance evaluations, and employment history.

Equipment Manual

An equipment manual is a document that provides instructions for the operation and maintenance of equipment. Equipment manuals are used in pharmaceutical companies to ensure that employees understand the proper operation, maintenance, and safety procedures for the equipment.

Safety Data Sheets (SDS)

Safety data sheets (SDS) also known as material safety data sheets (MSDS) are documents that provide information on the hazards and safe handling of chemicals. These documents are used to ensure that employees are informed about the risks and safety measures associated with hazardous materials.

Supplier Qualification

Supplier qualification documents detail the qualifications and approvals of suppliers to comply with relevant requirements. These documents are used for assessing the performance of suppliers for guided decisions on renewal/termination for outsourced services. Furthermore, these supplier documents are used by pharmaceutical companies to assess and verify that suppliers comply with the necessary quality, regulatory, and operational requirements.

Inventory Control Documents

Inventory control documents track the movement, storage, and usage of raw materials, components, and finished products within the supply chain. In the pharmaceutical industry, inventory control documents help ensure accurate tracking of inventory levels, expiration dates, batch numbers, and other critical information required for regulatory compliance.

Certificate of Analysis (CoA)

A certificate of analysis (CoA) is an official document issued by a manufacturer or supplier that certifies the quality and purity of a specific product, typically raw materials or finished pharmaceutical products. In the pharmaceutical industry, the CoA provides analytical test results for a particular batch, verifying that it complies with requirements. These certificates also give a level of confidence to manufacturers or users that the product complies with quality standards or requirements.

Risk Management Plans

Risk management plans are documents that outline strategies for identifying, assessing, mitigating, and monitoring potential risks associated with the development, manufacturing, distribution, and use of pharmaceutical products. The risk management plan is essential for proactively assessing potential risks, ensuring product quality and safety, and maintaining compliance.

Regulatory Submission Dossiers

Regulatory submission dossiers are collections of documents companies submit to regulatory authorities to request approval for the development, manufacturing, marketing, or modification of products. In the pharmaceutical industry, these documents provide information that allows regulatory agencies to evaluate the product’s safety, efficacy, quality, and compliance before granting market authorization.

What Are the Types of Records in the Pharmaceutical Industry?

A record is a document that shows proof of activities, decisions, or events. A pharmaceutical record is a document that captures evidence of actions, procedures, observations, or outcomes related to drug development, manufacturing, quality control, or distribution.

Twelve examples of types of pharmaceutical records are listed below.

  • Batch Master Record (BMR)
  • Batch Packing Record (BPR)
  • Product Release Note (PRN)
  • Training Records
  • Equipment Calibration Records
  • Equipment Maintenance Logs
  • Equipment Cleaning Records
  • Waste Disposal Records
  • Deviation Records
  • Audit Reports
  • Quality Control (QC) Records
  • Environmental Monitoring Record
Records in the pharmaceutical industry

Batch Master Record (BMR)

A batch master record (BMR) is documentation detailing the entire process of manufacturing a batch, including materials, equipment, personnel, and steps. In the pharmaceutical industry, the BMR is a component of Good Manufacturing Practices (GMP) and helps ensure that every batch is produced in a controlled and consistent manner.

Batch Packing Record (BPR)

Batch packing records (BPR) are documents that provide a detailed record of all packaging activities performed for a specific batch of a product. These documents are used to demonstrate the packaging process of a specific batch, including packaging materials and labeling, complies with requirements.

Product Release Note (PRN)

A product release note (PRN) is a record that provides a summary of all the information required for the release of a product for distribution. In the pharmaceutical industry, the PRN authorizes the release of a batch for sale or distribution after confirming it complies with relevant requirements.

Training Records

Training records are documented evidence that personnel have received the necessary training and qualifications to perform their assigned tasks. Pharmaceutical companies use training records to monitor the training content, dates of training, assessment results, and participant signatures.

Equipment Calibration Records

Equipment calibration records capture the calibration status and schedule of all equipment used in the manufacturing, packaging, and quality control processes. Within the pharmaceutical sector, equipment calibration records are used to show the calibration of equipment used in the manufacture, packaging, and testing of products.

Equipment Maintenance Logs

Equipment maintenance logs are records that demonstrate equipment maintenance, such as preventative maintenance, cleaning, disinfection, and replacement of parts. These records are used by pharmaceutical companies to record the maintenance activities performed on equipment to ensure its reliability and optimal working conditions.

Equipment Cleaning Records

Equipment cleaning records are documented evidence of the cleaning processes performed on manufacturing equipment, such as cleaning, disinfection, or sterilization. To prevent cross-contamination between batches, the pharmaceutical sector relies on equipment cleaning records as proof that the equipment is hygienic and free of pollutants.

Waste Disposal Records

Waste disposal records are records that provide information about the handling, storage, and disposal of waste materials, including hazardous and non-hazardous substances, generated during manufacturing, research, and other processes. These records are used in pharmaceutical companies to support compliance with environmental requirements and proper disposal of different types of waste products including non-hazardous or hazardous materials.

Deviation Records

Deviation records are documentation of any departure from approved procedures, processes, or specifications that occur during manufacturing, testing, or distribution activities that are impacting product quality. In the pharmaceutical sector, deviation records are essential for identifying and analyzing root causes, implementing corrective and preventive actions (CAPAs), and ensuring continuous process improvement.

Audit Reports

Audit reports are documents that detail the findings from internal or external evaluations conducted to assess compliance with applicable requirements. In pharmaceutical companies, audit reports demonstrate compliance with internal, customer, and regulatory requirements. These audit reports serve as a basis for developing CAPA plans to address non-compliances, supporting continuous improvement and risk management.

Quality Control (QC) Records

Quality control (QC) records are documents of all tests and inspections conducted to ensure that products comply with requirements, including evidence of testing completion and approval of results. QC records are used in pharmaceutical companies to record the testing and analytical results of raw materials, intermediates, and finished products to ensure they comply with relevant requirements throughout their lifecycle.

Environmental Monitoring Record

Environmental monitoring records are the documentation of environmental conditions within controlled areas, such as temperature, humidity, and contamination levels. These records are used to document the monitoring of environmental conditions and ensure that manufacturing environments remain within acceptable ranges to prevent product contamination and maintain quality.

What Is the Difference Between Documents and Records in the Pharmaceutical Industry?

The difference between documents and records in the pharmaceutical industry lies in their purpose and need for updates.

Documents provide information on how processes should be performed or managed. Documents should be updated as needed by the organization to ensure their accuracy and compliance with relevant requirements. The main purpose of documents is to be used before or during the activity to guide the operations.

Records are the documented evidence of actions taken and the results obtained. Records are proof that processes and procedures have been followed according to the established internal, customer, and regulatory requirements. These records are generated after an activity has been performed.

How Does a Pharmaceutical Document Management System (DMS) Work?

A Pharmaceutical Document Management System (DMS) is a system designed to manage and control all documents related to activities such as drug development, manufacturing, quality control, and distribution.

Document management system can be a paper-based system, electronic system, or even hybrid system – combining both paper and electronic features.

DMS integrates document management and document control capabilities to ensure documents and records are securely stored, easily accessible, properly versioned, and archived.

Seven steps in the workflow of a document management system are listed below.

  1. Document Creation and Upload: Documents are created within the system or uploaded to initiate the management process.
  2. Version Control: The system assigns version numbers and maintains a record of previous versions to ensure that only the most recent version is accessible.
  3. Access Control: Access to documents is regulated based on permissions, roles, and site, ensuring that only authorized users can view or modify documents.
  4. Document Review and Approval: Documents go through predefined workflows for review and approval, guiding users through the necessary steps to ensure proper document handling.
  5. Time-Stamped Audit Trails: All document activities, such as changes and approvals, are recorded with timestamps to maintain a traceable history for audits and inspections.
  6. Document Storage: Approved documents are securely stored in a structured system, making them easy to find and retrieve.
  7. Retention and Archiving: Documents are retained for specified durations according to regulatory requirements and securely archived when no longer needed.

Which Standards, Guidelines, and Regulations Specify Requirements for Pharmaceutical DMS?

The requirements for pharmaceutical document management and control are specified by various standards, guidelines, and regulations.

Key standards, guidelines, and regulations that specify the requirements for pharmaceutical documents and records are listed below.

  • 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
  • ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
  • ICH Q10 (Pharmaceutical Quality System Q10)
  • ICH E6 (R2) (Guideline for Good Clinical Practice)
  • EudraLex Volume 4 GMP Part I
  • PIC/S Part I (Guide to Good Manufacturing Practice for Medicinal Products)
  • ISO 9001:2015 (Requirements for Quality Management Systems)

These standards, guidelines, and regulations are explained in more detail in this section. These requirements are applied to document management systems in any format, whether paper-based, electronic, or hybrid.

21 CFR Part 211

21 CFR Part 211 is a regulation by the U.S. Food and Drug Administration (FDA) that specifies the current good manufacturing practice for the preparation of drug products.

Regarding the requirements for records and reports, Section 211.180 outlines that records must be readily available for inspection and retained by the appropriate period. Records must be maintained for production, control, distribution, components, containers, closures, and labeling.

Written records must be maintained for annual evaluations of drug product quality, including batch reviews, complaints, recalls, and investigations.

ICH Q7

ICH Q7 is an international guideline that provides a good manufacturing practice guide for active pharmaceutical ingredients.

Section 6 outlines that documents and records related to the manufacture of active pharmaceutical ingredients must be prepared, reviewed, approved, and controlled according to written procedures.

Entries in records should be made immediately after performing activities, with corrections dated and signed, while ensuring that records are readily accessible during the retention period.

ICH Q10

ICH Q10 is the International Council for Harmonization’s Guideline on the Pharmaceutical Quality System (PQS). ICH Q10 guideline provides a comprehensive framework for establishing and maintaining a quality system that ensures the consistent delivery of high-quality pharmaceutical products throughout their lifecycle. ICH Q10 pharmaceutical quality system incorporates the concepts of Good Manufacturing Practices (GMP) and is in line with ISO 9001, the universal standard for quality management systems.

Several sections of the guideline contain important references to documentation, as listed below.

  • Section 1: Emphasizes that a well-designed Pharmaceutical Quality System (PQS) supports strong adherence to documentation practices throughout the product lifecycle, continual improvement, and regulatory compliance.
  • Section 2.1: Mentions that documentation is a critical part of managing quality throughout the product lifecycle.
  • Section 3: Specifies components of the Pharmaceutical Quality System where documentation is needed. The section includes process performance and monitoring, corrective and preventive actions (CAPA), change control, and management review.
  • Section 4: Draws attention to how crucial senior management is to make sure the PQS has efficient document control and management procedures.
  • Section 5: Requires traceable records of quality issues, root cause analyses, and implemented improvements, documentation is essential to facilitating continuous improvement.

ICH E6 (R2)

ICH E6 (R2) is an international guideline that specifies good clinical practice for clinical trials involving humans.

Section 4.9 requires that investigators and institutions maintain accurate clinical trial documents and records, ensuring data is accountable, legible, and complete. Changes to documents must be recorded with dates, initials, explanations, and an audit trail.

Investigators must provide access to clinical trial-related records upon request from monitors, auditors, or regulatory authorities.

EudraLex Volume 4 GMP Part I

EudraLex Volume 4 GMP Part I is a European guideline that specifies the basic requirements for medicinal products used in human and veterinary medicine.

According to Chapter 4, sections 4.1 to 4.6, documentation must be defined, controlled, and managed across all media types, whether electronic, paper-based, or hybrid.

Documents within the quality management system must be regularly reviewed and updated, ensuring accuracy and compliance. Procedures must be approved, signed, dated, clearly written, versioned, and have a defined effective date.

PIC/S Part I

PIC/S Part I is an international guideline that provides good manufacturing practices for medicinal products.

Chapter 4, sections 4.7 to 4.9, outlines the requirements for good documentation practices. Records should be created or completed immediately as each action is performed, ensuring traceability of all activities. Any changes to documents must be signed and dated, and the original information should remain readable, with the reason for the change recorded when necessary.

ISO 9001:2015

ISO 9001:2015 is an international standard that specifies the requirements for a quality management system.

Section 7.5.3 requires documented information to be accessible and suitable for use when needed and protected from issues such as loss of confidentiality or integrity. The company must manage activities, including distribution, access, retrieval, storage, preservation, and change control, as well as retention and disposition of documents.

External documents necessary for quality management must be identified and controlled, and records must be protected from unauthorized changes.

What Is the Role of Pharmaceutical Document Management Software?

Pharmaceutical document management software streamlines the organization, storage, retrieval, and distribution of documents throughout their lifecycle. Pharmaceutical documentation software ensures that documents such as SOPs, work instructions, manuals, and records, such as batch records, audit logs, and regulatory submission dossiers, are managed efficiently and securely. It supports compliance with relevant requirements, maintains document version control, facilitates audits by providing traceable records, and offers easy document access.

Document management is an essential component of quality management software, ensuring that all documents are handled in accordance with standards, guidelines, and regulations.

SimplerQMS offers life science QMS software with robust document management capabilities, enabling pharmaceutical companies to efficiently manage and control documents and records throughout their lifecycle. The system provides predefined workflows, automated routing for review and approval, secure storage, version control, and easy access to documents.

SimplerQMS provides comprehensive QMS support, including not only document management but also change control, training management, supplier management, deviation management, CAPA management, audit management, and equipment management, among others.

SimplerQMS ensures compliance with life science QMS requirements, including those related to document management and control, as specified in standards, regulations, and guidelines such as ISO 9001:2015, 21 CFR Part 211, and ICH Q7, among others.

Discover how SimplerQMS can optimize document management and streamline other aspects of your quality management system. Book a personalized demo to connect with our Quality Solutions experts and see the benefits firsthand.