21 CFR Part 11 Compliant Software to Automate Biotech Quality Processes to Comply with FDA, EPA, and USDA Regulatory and Quality Requirements
The burgeoning biotech industry includes pharmaceutical companies, agricultural, mainstream manufacturing, and energy companies. Biology-based businesses produce a wide range of products (from cancer drugs to biopesticides) and develop cutting-edge technologies (from DNA-fingerprinting technology to biotech environmental processes for cleaning up hazardous wastes). Like other regulated industries, the need for an electronic quality management system in biotech companies to help control documents, training and quality processes is significant. MasterControl can help connect these processes in an easy-to-use web-based system.
Automate Biotechnology GxP Processes with MasterControl
MasterControl, a developer of GxP process management software, has created MasterControl Documents, the solution that functions as a biotech CMS and automates a variety of quality processes that are often unnecessarily managed with manual procedure.
Creating a Paperless Process Using MasterControl (3:38)
Using MasterControl for FDA Compliance (3:53)
A.P. Pharma (10:23)
Regulatory Requirements for Biotechnology Companies
The biotech industry is regulated by the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA). Products are regulated according to their intended use, and some are regulated by more than one agency. The pharmaceutical segment is covered by a number of regulations, including the FDA's 21 CFR Parts 210-211. Pharmaceutical companies are covered by 21 CFR Part 11 if they maintain electronic-record keeping systems. Many biotech companies also conform to ISO 9000 quality management standards and ISO 14000 environmental management standards.
Biotechnology Quality Challenges
For a biotech company developing a drug or therapy, the ultimate goal is to ensure the safety, reliability, and high quality of the product. To achieve this goal, the company must address many challenges, including:
- Inefficient Quality System: Biotech companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections.
- Disconnected Processes: Quality processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
- High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double a company's compliance cost.
MasterControl Integrated Biotechnology Quality Management Software Solution
Compliance is a state, not an event. A biotech company must not only attain compliance, but sustain it year after year. The MasterControl integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Contact a MasterControl Biotechnology Representative
To learn more about a biotechnology CMS solution, please feel free to contact a MasterControl representative regarding the MasterControl Documents solution. For additional reading (i.e. white papers, tech papers, etc.) please refer to the MasterControl Resource Center.
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