Q&A: Document Control that Meets Business and Regulatory Standards
Most companies don't manage and control their documentation for the sole purpose of complying with SOX regulations, with ISO standards or with the FDA, but it doesn't hurt to consider your regulatory needs when you're "in the market" for a web-based document control system.
Here are some questions and answers to consider:
Q: Are there regulations or standards that govern your industry and require the documentation of documents associated with quality and regulatory management (e.g., documentation of deviations, customer complaints, CAPA trails, change control, submissions, etc.)?
A: If your company exists in this type of environment you are certainly in need of a document control system that manages and controls documentation without slowing it down. You are also likely to need a QMS CAPA system that integrates with the same web-based platform that the document control system is launched from. The QMS CAPA system should not route every issue or event to the CAPA system but should incorporate the intelligence required to conduct and lead users through a risk management process and a resolution process that will close out all issues and events with a low level of risk. All remaining issues and events that have been reported should then be routed to the CAPA system where additional prompts and intelligent forms should await users so that CAPA management is not entirely dependent on expertise as it was in the 80s and the 90s.
Q: Do regulatory measures over your industry require protected digital signatures when using an electronic document control system?
A: If this is the case then the answer is simple; at least it's fairly simple. Your company needs to find a document control software system that allows for the protection and usage of digital signatures and of course the system will need to be validated. Look for a document control system that already provides TOQ validation and other forms of validation tools and props. Validation aids can save busy companies half the cost of a "typical" software validation.
Q: Do certain regulations that affect your company's business demand that suppliers are audited and controlled?
A: In a time where 3rd-party suppliers reign supreme a great deal of manufacturing and research can be accomplished. However, 3rd-party suppliers often create a severe danger for the companies that are responsible for their "wares." If this is the case for your company, invest in a web-based supplier management solution that can be launched from the same web-based platform as a document control solution. An audit solution that automates supplier and internal audits would also be of the utmost value.
Q: When documents are changed do they generally lead to new training tasks for employees? And do certain standards that regulate your industry demand that training is controlled and recorded?
A: If this is the case you simply need a document control system that manages documents in such a way that when documents are edited training tasks can automatically be launched, routed, escalated and recorded. The system should also incorporate easy-to-create exams and reports for the ideal training audit trail.
Our Day. Our Regulations.
It seems that the more opportunity a company acquires the more it must be responsible to the processes that will allow its management and employees to fully take advantage of these same opportunities. From global expansion to the latest of technology opportunity is available for all regulated companies, small, medium or large.
Marci Crane is a marketing communication specialist for MasterControl in Salt Lake City, Utah. For more information in regard to document control software solutions that incorporate features for regulatory compliance, please feel free to contact a MasterControl representative.
Article Source: ArticlesBase.com - Q&A: Document Control that Meets Business and Regulatory Standards