Document management and control are critical components of an organization’s quality operations. Good manufacturing practices, FDA regulations, ISO requirements and other global regulations and standards require that companies manage versions, control employee access, facilitate training initiatives and implement appropriate change control procedures for all organizational documents.

Many organizations employ a multitude of approaches to document control, ranging from paper-based and manual processes to globally dispersed and outmoded electronic systems, including spreadsheets and databases. These companies struggle to achieve a collaborative and controlled work environment, ultimately incurring high costs related to managing documents and other content while facing crucial compliance and operational risks.

In manufacturing, managing the immense amount of data, content and documents can become a full-time job. Controlling inspection sheets, audit reports, nonconformance documents, corrective and preventative actions (CAPAs), customer complaints and inquiries are daunting and resource-draining tasks. Simply using the medical device manufacturing industry as an example, FDA’s Center for Devices and Radiological Health (CDRH) has a full manual section dedicated to proper handling of document control.

Many manufacturers across additional vertical markets can just as easily fall prey to quality issues without proper document control procedures in place. At best, these result in organizational inefficiencies and poorly allocated resources. At worst, the cost of poor quality can result in negative brand perception, lost revenue or liability.

Systematic, Enterprisewide Control

In the past, document control operations at manufacturing companies were left to siloed departments within the organizations. This proved ineffective, as different departments lacked visibility into the necessary document control procedures being implemented within other departments.

Yet more and more, companies are awakening to the fact that in order to stave off any issues associated with production processes and procedures, systematic, enterprisewide controls must be put in place. Enterprise software systems on the market today provide the level of management and control these organizations need and, in turn, can improve productivity, reduce production costs, ensure compliance and reduce risk.

Tightly integrated, comprehensive systems work to control document access and revisions across the enterprise from within a single, centralized department. Additionally, these systems manage, track and record documents to ensure product quality and regulatory compliance. This can apply for documents that include:

• Validation documentation
  
• Manuals and instructions
  
• Project documentation
  
• Investigation evidence, such as photographs
  
• Contractor paper batch records and supporting documentation
  
• Reports and follow-ups from external auditors
  
• Regulatory submissions and correspondence
  
• CAPA objective evidence
  
• Certificates of analysis (COAs)

Using a quality management system to control and regulate document access, companies can not only improve visibility and control revisions across multiple departments, but they also can provide the necessary level of automated communication to those people who are affected by the changes.

What to Look for

For the most effective document control measures, manufacturers looking to leverage a document control system must evaluate the following types of critical functionality to ensure that all facets of the information lifecycle are addressed within one framework for secure and progressive business growth:

Centralization

Electronically and securely manage all information in a centralized, scalable and reliable system to eliminate the potential of lost information

Centralized management of all change control items on quality management software to eliminate redundant systems and decrease production costs

Enforce consistent, harmonized processes and procedures across the organization to reduce liability and risk

Assign document training to responsible parties, monitoring due dates through interactive dashboards to increase accountability and visibility

Automation

Notify other departments and sites automatically when problems occur to increase visibility and reduce product impact

Implement electronic review and approval processes to improve efficiency

Automate and enforce specific actions to comply with ISO and other industry regulations

Integration

Link document controls to other quality management processes

Integrate reporting and escalation to accelerate cycle time and batch release

Integrate workflow from other quality management initiatives for enhanced collaboration and productivity

Leverage current document management systems within the quality management system framework for a best-of-breed approach to managing quality manufacturing processes

Get the Most From the System

After a system has been selected, implementing and maintaining critical document control measures across the enterprise can be accomplished using four simple steps, resulting in both measurable and unquantifiable benefits. These steps are:

1. Ensure compliance by establishing a centralized repository for policies, procedures and other controlled content.

Create a centralized information hub and establish strict policies for controlled information access. Limit document access to within this framework to maintain control while reducing redundant systems and streamlining ineffective policies.

2. Improve control of sensitive data by enforcing role-based security rights for access to documents and other content.

Leverage a security-rights framework to enforce role-based policies, including permissions, user identification and authorization level. Be sure to use restrictions and program access to allow and control appropriate documents and other forms of sensitive company information.

3. Reduce the risk of deviations resulting from employee access to outdated or obsolete procedures and work instructions.

Track access to previous and current versions of important documents using established controls and notifications. Enforce policies by enabling user collaboration capabilities and access through a Web-based interface. Use an administrative console to allow both business users and delegated rights administrators to access the documents through the terminal.

4. Create a scalable framework that allows organizations to add additional document types and processes to further increase worker productivity and foster continuous improvement and collaboration.

Allow authorized administrators to regulate and add additional activities, documents, data and information types that affect the business. Use role-based policies to monitor and control these administrative tasks, alerting appropriate parties when appropriate.

5. Ensure a closed loop process to manage and track remediation of issues and incidents that result from violations of policies and procedures, risk assessments, internal audits, regulatory commitments and customer complaints.

Creating a closed loop process reduces risk by tracking the entire process from event initiation through resolution including resulting changes and necessary training.

Without a centralized and enterprisewide approach to document management and control in the realm of quality manufacturing, companies leave themselves vulnerable, unable to handle critical and sensitive documents and information that affect quality and compliance across the manufacturing operation. Establishing document management and control within the quality management framework improves manufacturing processes, progresses collaboration, leverages existing resources and drives organizational efficiencies that affect the company’s bottom-line business objectives.

Tech Tips

Manufacturers looking to leverage a document control system must evaluate the following types of critical functionality:

Centralization. Does the system electronically and securely manage all information in a centralized, scalable, and reliable system to eliminate the potential of lost information?

Automation. Does the system notify other departments and sites automatically when problems occur to increase visibility and reduce product impact?

Integration. Does the system link document controls to other quality management processes?