Document control is critical from both a practical and compliance perspective.
When documents change it is important to consider the ripple effect this will cause across the business. What impact will changes have on products, audit processes, the equipment used, staff training and competency requirements?
These critical issues must be assessed before and after implementing a document control system. They need to be an integral part to your document management strategy and the system used to manage and control the document lifecycle must be fit for purpose.
Managing the change control process is when an electronic document management system can come into its own as change management can be difficult and complicated to maintain. It is vital that there is one point of reference for all aspects of document management: one version of the truth so to speak.
Paper-based systems for the most part do not offer this one centralised system to document control: often information is held in multiple locations, across different sites. With documents potentially being stored on various servers, applications, files and cabinets, the risk of not properly controlling changes to information contained within them increases substantially. Furthermore, even if there is only one filing cabinet to contend with, the manual process of updating documents and communicating & distributing the changes/new version to stakeholders opens the organisation up to risk.
Obviously, this is something to be avoided as much as possible due to the negative impact it could have on meeting regulatory compliance requirements and on business performance overall. With standards, such as ISO 9001:2015, evolving to introduce a more risk-based thinking to quality management, organisations should perhaps now be looking to implement this type of approach.
An electronic quality management system (eQMS) can make document control more efficient and minimise risk as it provides closed-loop quality management processes within a single system. With an eQMS, any changes or revisions to documents can be implemented and integrated in a secure and controlled environment with subsequent ‘ripple effects’ being pre-empted, planned and managed effectively.
Audit trails, related documents, version control, workflows and knowledge management within an eQMS allows for effective document lifecycle management and gives stakeholders confidence in consistent compliance to regulations and standards.
Ideagen's Q-Pulse, an electronic quality management system, delivers confidence for customers worldwide in maintaining effective document control. For more information on Q-Pulse, visit our product web pages.