Harmonized Documentation: By Kenn Milton
Document Management, a controlled and consistent process.
General Knowledge & Insights
Documented information is the essential part of proving that a system works according to the specifications and that the repeated output is consistent. The purpose of Document Management is to ensure that a consistent and controlled process is followed when creating, reviewing and approving documentation in the system life cycle. The documentation must follow a predefined document naming convention to keep a defined structure within the document repository and to distinguish the documentation from other system documentation.
The Document Management procedure should be generated to make one documentation style for the Standard Operating Procedures (SOP) and System Development Life Cycle (SDLC) Documents. This is to present a standardized and harmonized documentation for procedures and systems regardless of the source template format and the author of the document. All documentation must follow the basic rules of Good Documentation Practice to make documents understandable, accurate and consistent.
There is a risk in writing documentation from scratch every time. It takes time, and the writing style might be different from person to person. Small and Medium-sized Businesses (SMBs) are great at implementing solutions but unfortunately most people do not consider documenting the work as an asset or show any interest in it. This can result in important information not being documented and information can in worst-case-scenarios get lost. To avoid this risk, there lies great opportunity in an easier documentation by making templates available. Good examples should be shared, and the very specific details unique to every project should preferably only be inserted. As a result, the authoring of the documentation will accelerate and also the review and approval cycle, since the common expectations are already known by the independent reviewers and approvers.
Business & Leadership
The leaders in a business must ensure that the process-experts’ knowledge is scaled across the organization. The documentation expectation has to be communicated and the expected output must be made easy available. Document templates that includes guidance of expected input and output can be shared with the project teams. Making the correct templates available at the right time will enhance the the productivity. Working with integrated processes and linking documentation with project activities and supporting processes will optimize performance and increase compliance. Encouraging collaboration and “lessons learned” will automatically set new and higher standards for the employees in the company as their competencies will be lifted and they will through teamwork ensure that know-how is secured within the organization.
Focusing on documented information is important in Quality Management across many industries. In the Life Science industry specifically, documentation must be approved by at least one other person besides the author and must be approved by Quality Assurance for GxP, if applicable, and a sequence of reviews and approval cycles is also often required. Any Computerized System used in Life Science must be validated and documented. Documentation requires an Audit Trail, which means that the documentation must be time stamped, and the person approving the document, including the time and date is required to give a clear reason for signing. There are specific requirements for an electronic signature in various regulations i.e. 21 CFR Part 11 (Electronic Record; Electronic Signature) or EudraLex – Volume 4, Annex 11 (Computerized Systems)
Document Management Today
In larger companies, templates are made available in shared repositories. It is up to the single project team to identify which templates are relevant for which task. It takes a long time to find the correct templates for the project scope and communicating the expectations can be difficult.
Documentation today is often written from scratch and when submitting the document for review, the content is not in the expected quality, format or style, which means the the document must go through multiple review cycles. When documents are finally approved, they are stored in shared repositories, that are disconnected from the project activities and documentation is manually searched by the reference IDs instead of being easily available in an integrated solution.
Small and Medium-sized companies cannot or have little possibility to leverage from earlier projects, and will have to write the procedures, and documentation for the first time. This is a very time-consuming activity, which is why companies often hire consultants that can extract from previous experiences to help on the particular project. Smaller companies should benefit from the opportunities to work smarter and should look for a solution that is made for quality management, that links documentation with project management and critical to quality processes. When the basic expectations on managing projects are known, the time and expenses can be minimized
Future prospects of Document Management
Automation, robotics and machine learning is in the future for Document Management. These future possibilities will assist the business analysts in capturing the stakeholders’ expectations and illustrate the business processes to be able to identify the risks based on previously monitored results.
Requirements are automatically recorded in the format of being Specific, Measurable, Achievable, Realistic and Testable (SMART) and are categorized according to topics and areas of compliance.
With the use of robotics, duplications will be easily identified and Machine Learning can contribute to documentation review. Automation (or robotics) give businesses the possibility and the unique advantage of giving the same expected result every time. Tracking and tracing stakeholders’ expectations against system functionality and formal verification will be an automated task and quality checks, governance and approval will be ensured by System Owners, Quality Managers and Quality Assurance.