Meet cGMP Requirements with Risk-based Commissioning Qualification Validation Software

There are several challenges in using the traditional paper-based approach to manage your commissioning, qualification and validation processes.

• Data loss and rework: Facility and equipment CQV activities must provide documented evidence that the premises, supporting utilities, equipment and processes have been designed, installed and operate according to current good manufacturing practice (cGMP) regulations. Qualification and validation are documentation-heavy tasks. In a manual system, those records can be easily lost due to human error or a natural disaster such as a fire or flood. Lost data cannot be easily retrieved or verified. Employees spend hours repeating work that has already been carried out.
• Poor risk management: Manual validation methods lack uniform tools and strategies for conducting consistent risk analyses. Without a suitable method for assessing risk, it's difficult to distinguish between critical and non-critical issues. This results in increased compliance risk and increased costs because valuable resources are focused on the wrong problems.
• Over-reliance on tribal knowledge: Manual systems rely heavily on tribal knowledge, i.e., knowledge held by a single individual or group. Tribal knowledge is dangerous, particularly in regulated environments. When the knowledgeable individual leaves the company, essential details, which could be critical during an audit, are gone for good. 
• Maintaining continuous compliance: Facility CQV is not a one-time step. You must revalidate and conduct periodic reviews to ensure the system is not trending out of specification. You must install proper procedures for change control and deviation management. Compliance is a continuous effort and cumbersome with manual processes.
• Time and resource drain: Manual equipment and facility CQV processes require tremendous personnel hours in routing documents, obtaining signatures and approvals, and searching and retrieving paper files during audits and inspections. Staff members are pulled from their primary duties to perform non-value-added tasks, significantly impacting productivity and morale. By adding automation, you free your staff to focus on more important, revenue-generating activities.
• Lack of visibility: Disconnected processes and disparate systems make accessing the information you need when you need it virtually impossible. Lack of real-time visibility negatively affects good decision-making, which increases your quality and compliance risks.