The biotechnology or biological product sector of the pharmaceutical industry is at the forefront of the development of the most advanced and complex medicines and therapies today. Given the complexity of the field, biotech companies face strict regulations that require the highest levels of accuracy and quality standard. Any product deviation (planned or unplanned) from approved procedures potentially affects quality, and therefore, compliance.

Sometimes called an out-of-specification (OOS) result, a biological product deviation may occur during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution. Effective control of every biological product deviation from material specifications and release specifications is an essential component of quality improvement and compliance.

How can MasterControl Product Deviations™ Software Benefit You?

The MasterControl deviations software solution automates and manages the documentation, investigation, and resolution of every biological product deviation from written procedures, including release specifications and material specifications. The software not only efficiently resolves a deviation, but uses the data collected as a basis for continuous quality improvement, which is also critical to FDA compliance.

Ensuring Continuous Validation™ for Product Deviation With FDA GMP Compliance

MasterControl considers validation an integral part of our software solutions for FDA-regulated customers. Our "continuous validation" approach dramatically cuts the time, pain, and cost involved in validation, making it easier to validate future upgrades. MasterControl's continuum of products and services address different levels of validation needs based on individual risk assessment and product deviation.

Here's how the MasterControl software for biological product deviation addresses some of the major challenges that companies face when resolving planned and unplanned deviations.

The Ultimate Product Deviation Management Software by Master Control

MasterControl Deviations is an ideal deviation management software solution for controlling product deviation incidents, for helping avoid their recurrence, for taking a proactive approach to continuous quality improvement, and for assuring FDA and GMP compliance. The software's key features are outlined below.

• Best-Practice Form and Process : A pre-configured, multi-page form prompts participants to collect all relevant data and guides them through the process while allowing responsible personnel to make the appropriate decisions regarding product deviation. The form is automatically routed to the appropriate personnel and can be escalated if not processed in a timely manner. This best-practice form facilitates compliance with deviation-handling requirements of 21 CFR Part 211.
• Four-Step Process with Electronic Approval Signatures: This best-practice workflow guides users through the entire process of resolving a biological product deviation, from the initiation through the investigation, resolution, and approval processes.
• Integrated with CAPA Process: The MasterControl deviation control software can be integrated with MasterControl CAPA, so that serious deviations can immediately move on to the process of corrective/preventive (CAPA).
• Integrated with Nonconformance Process: When integrated with MasterControl Nonconformance any deviation that results in a material nonconformance will automatically move to the nonconformance disposition process.
• Integrated with Electronic Batch Records Process: The biological product deviation software from MasterControl connects with MasterControl Electronic Batch Records to create a complete automated solution for manufacturing operations.
• Form-to-Form Launching: A CAPA form or a nonconformance form can be launched directly from the deviation form. By the same token, a product deviation form can be launched from a control recipe form in the MasterControl Electronic Batch Records solution. MasterControl maintains the links so that a completed process can easily be reviewed to see what triggered it. Relevant information from the deviation form is automatically transferred to the launched form, reducing data entry and increasing accuracy. This integrated approach makes it easier to comply with 21 CFR Part 211 quality management requirements.
• Analytics Reporting Tool: This built-in tool comes with a standard set of pre-configured reports that can be adjusted and customized by the user. Planned and unplanned deviations can be trended and analyzed by process, product, vendor, etc. These "data-mining" capabilities can provide important insight into quality issues affecting the product deviation system and serve as yet another starting point for CAPA.
• FDA 21 CFR Part 11 Compliant System: As with all software developed by MasterControl, the product deviation software solution is fully compliant with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval, password expiration, encryption, and certification.

To Learn More on Product Deviation

For more information about product deviation or deviation management software, please feel free to contact a MasterControl representative.