Validation and Waiver Services

One of the keys in selecting the most appropriate electronic records management software is to look for a system that meets regulatory standards required within your industry. P-Wave's software has been audited and determined to meet the requirements of the regulatory agencies that governs each of our market segments.

FDA regulations specifically 21 CFR Part 11 pertain to electronic records and electronic signatures, includes a requirement to validate electronic record-keeping systems to ensure the accuracy, reliability, and consistent intended performance of the system, as well as the system's ability to detect invalid or altered records.

Even though P-Wave's system meets the requirements of 21 CFR Part 11, FDA compliance with this regulation is not assured until an audit is performed with the system installed in the laboratory and a determination made that all requirements are met. For many companies, the process of validating the electronic record-keeping system is likely to be complex and costly. P-Wave can significantly ease this burden through its comprehensive validation services provided through its partners and advisors (See Partners Section). These services include:

• Full-cycle Validation - P-Wave expert partners and advisors can go onsite to conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation tests and resolve any testing deviations.
• Continuous Development - To sustain compliance, a company must make sure that its system remains in a constant state of validation. P-Wave expert partners and advisors continuously develop new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

Many U.S. federal and state agencies, such as the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and the Department of Environmental Protection (DEP), are increasing their expectations for strict blast accounting and documentation. With blasting companies now facing regular documentation audits, potential liability issues, due to the lack of or inconsistent documentation, may arise. The Master Blaster system is currently the only system with an ATF Letter of Determination validating it meets the regulations of the Federal Explosives Law as a record keeping system pursuant to 27 CFR Part 555 Subpart G.

Explosives companies implementing computerized systems to manage inventory would be required to submit a variance to the ATF requesting permission to maintain their records in a computerized format. For many companies, the process of applying for the variance to the ATF can be time consuming, complex and slow. P-Wave can significantly ease this burden through its comprehensive variance services for computerized systems.