For FDA regulated companies, on a tighter budget, the option of having some or all of the Quality Assurance (QA) functions and responsibilities being managed and performed by a “Virtual QA” is a viable alternative in terms of efficiency and cost savings versus a traditional full-time QA Manager, Supervisor, and Coordinators/Associates.
Functions That Can Be Outsourced
Compliance Insight provide Virtual QA functions. The areas that can be outsourced to a Virtual QA are many; among them:
- Writing of: SOPs, Batch records, Protocols (Validation, Qualification, Stability, etc)
- Conducting investigations (OOS, deviations, equipment or utility issues, etc.)
- Overseeing the CAPA program
- Audits: execution of internal and external audits
- Master Batch Record control
- Production Batch Records review
- Assist before, during, and after audits by Regulatory Agencies (FDA, EMEA, etc)
- GMP Training
- Product release
- Change control
- Handle customer complaints
- Label control
Benefits of Virtual QA
The Virtual QA will always be on-call (24/7) and accessible via different means of communications (cell phones, emails, faxes, land-lines phones, text messages, skype, etc).
Per regulations, the QA department in any GMP organization must be independent from Production. In other words, a Production associate cannot perform any of the functions requiring QA approval (ex: final release of finished products or intermediates; final approval of investigations, change controls, deviations, audits, specifications, SOPs, Protocols, Manufacturing Records, etc.).
For larger operations, the company may be able to operate within regulations with only one associate in the QA department during periods of normal operation. These companies frequently outsource some of the QA functions periodically when QA work load increases in order to effectively managed the Quality systems on the continuous basis. A Virtual QA can be the support for this single QA associate organization by covering all the GMP areas that cannot be covered by the single QA Associate. Also, when this single QA associate is on-leave, for any reason, the Virtual QA who is familiar with the company’s mode of operation can cover in their absence.
Another area of cost savings by a Virtual QA is in the “cost of quality”. It is well established that violations to the GMP regulations are very expensive in the long run. The cost of not maintaining a quality centered company includes potential recall, FDA form 483, Warning Letter, a Consent Decree, monetary fines imposed by the regulatory agency, down time to fix the issues, as well as the loss of confidence by the consumers, clients, and employees. Trying to minimize the importance of QA in an organization, by keeping the staffing to a level lower than required to benefit the bottom line can lay the ground for a disaster. A Virtual QA could represent a practical and financially responsible solution by only using their resources on the “as-needed” basis, thus minimizing fixed salaries and fringe benefits.
Virtual QA means instant experience at a reduced cost and without increasing overhead count.
Compliance Insight is an expert in providing Virtual QA services. Contact us today to learn if a Virtual QA service is right for your organization.