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