CAPA and Web Document Management for Growing Medical Device Companies
Marci L. Crane
January 02, 2009
It is highly unlikely that growing medical device companies will invest in expensive ERP systems and massive DMS solutions. However, a growing medical device company has the need to start streamlining systems from the point of start-up, or at least from the point of multiple-product marketing.
Automating at a "small-scale" level will save growing medical device companies valuable time and serious revenue in the future---that is, of course, if the software purchased can grow in a corresponding manner the medical device company in question.
Two Important Systems
For many growing medical device companies two of the most important systems that can be automated are CAPA and web document management solutions. It is absolutely necessary that these solutions can 1) grow as the company grows and 2) that they can be launched from the same web-based platform.
CAPA for Growing Medical Device Companies
For every medical device company, a CAPA system is inevitably required (see 21 CFR Part 820). Many companies however currently choose to manage their CAPA system manually. This of course, may prove fruitful during a 90-day, start-up race toward the generation of one product but once a medical device company is marketing multiple products and managing multiple iterations, administering a CAPA system manually, with paper and with disparate solutions, is nothing short of professional suicide.
CAPA Automation: The Benefits
A CAPA system, when automated effectively, can literally become the lucrative funnel that that sorts through and leads to the remediation of--if necessary--issues (e.g., deviations, nonconformance events, audit findings, customer complaints, etc.) faster and more effectively than any paper-based system could be expected to handle. With the right web-based solution, growing medical device companies can repopulate information from Form 483 findings, customer complaints, deviations, etc. to electronic CAPA forms which can then be resolved (i.e., approved) or automatically routed to the appropriate personnel for further investigation.
Web Document Management Software
Web document management software can be very useful in growing medical device companies especially if the system is designed to grow as the company grows. An automated web document management solution can manage the growing documentation that is common as quality and regulatory groups become well established. After all, it is at this point that medical device companies really start to "feel the pain" in terms of quality and regulatory expectations. This is also the time when a medical device company may experience one of their first FDA audits, and a web document management solution can help to provide quick centralized access to any documentation (or any document's audit trail for that matter) over which an investigator might choose to glance. What would be more impressive to an FDA investigator than a web document management and CAPA system that really works?
BOM (Bill of Materials) Software
Another software solution valuable to a growing medical device company is a BOM, or Bill of Materials, solution. During the rapid growth stage that many medical device companies experience, it is common to have one product branch into multiple products with multiple iterations. These products and iterations with their accompanying bills of materials can be difficult to manage especially if related suppliers' items or services must be tracked and managed as well. Medical device companies that face these issues now and find the right BOM and supplier management software (as well as CAPA and web document management solutions) can continually will find themselves in a far more comfortable situation when it comes time to compete with other medium-sized companies or to burgeon into a large corporation.
Marci Crane is a marketing communication specialist for MasterControl in Salt Lake City, Utah. For more information in regard to CAPA MD™, web document management, or BOM software solutions, please feel free to contact a MasterControl representative.
Automating at a "small-scale" level will save growing medical device companies valuable time and serious revenue in the future---that is, of course, if the software purchased can grow in a corresponding manner the medical device company in question.
Two Important Systems
For many growing medical device companies two of the most important systems that can be automated are CAPA and web document management solutions. It is absolutely necessary that these solutions can 1) grow as the company grows and 2) that they can be launched from the same web-based platform.
CAPA for Growing Medical Device Companies
For every medical device company, a CAPA system is inevitably required (see 21 CFR Part 820). Many companies however currently choose to manage their CAPA system manually. This of course, may prove fruitful during a 90-day, start-up race toward the generation of one product but once a medical device company is marketing multiple products and managing multiple iterations, administering a CAPA system manually, with paper and with disparate solutions, is nothing short of professional suicide.
CAPA Automation: The Benefits
A CAPA system, when automated effectively, can literally become the lucrative funnel that that sorts through and leads to the remediation of--if necessary--issues (e.g., deviations, nonconformance events, audit findings, customer complaints, etc.) faster and more effectively than any paper-based system could be expected to handle. With the right web-based solution, growing medical device companies can repopulate information from Form 483 findings, customer complaints, deviations, etc. to electronic CAPA forms which can then be resolved (i.e., approved) or automatically routed to the appropriate personnel for further investigation.
Web Document Management Software
Web document management software can be very useful in growing medical device companies especially if the system is designed to grow as the company grows. An automated web document management solution can manage the growing documentation that is common as quality and regulatory groups become well established. After all, it is at this point that medical device companies really start to "feel the pain" in terms of quality and regulatory expectations. This is also the time when a medical device company may experience one of their first FDA audits, and a web document management solution can help to provide quick centralized access to any documentation (or any document's audit trail for that matter) over which an investigator might choose to glance. What would be more impressive to an FDA investigator than a web document management and CAPA system that really works?
BOM (Bill of Materials) Software
Another software solution valuable to a growing medical device company is a BOM, or Bill of Materials, solution. During the rapid growth stage that many medical device companies experience, it is common to have one product branch into multiple products with multiple iterations. These products and iterations with their accompanying bills of materials can be difficult to manage especially if related suppliers' items or services must be tracked and managed as well. Medical device companies that face these issues now and find the right BOM and supplier management software (as well as CAPA and web document management solutions) can continually will find themselves in a far more comfortable situation when it comes time to compete with other medium-sized companies or to burgeon into a large corporation.
Marci Crane is a marketing communication specialist for MasterControl in Salt Lake City, Utah. For more information in regard to CAPA MD™, web document management, or BOM software solutions, please feel free to contact a MasterControl representative.