Production and Process Controls
Process controls ensure that devices are manufactured in accordance with specifications despite external factors such as changes or deviations from standard manufacturing techniques, fluctuations in environmental conditions, and human factors. Because the quality of a finished product depends in part on the quality of the manufacturing process, the FDA's quality system (QS) regulation requires device manufacturers to implement effective procedures, standards and controls for production processes and equipment.
Quality System Software Validation
QS regulation 820.70(i) requires that software programs be validated for their intended use according to an established protocol when computers are used as part of an automated production or quality control system. Engisystems will work with you to identify and validate the Quality System software in your network:
- Enterprise Software (ERP, CAPA Software, Document Control Software, Databases, etc)
- Custom or off the shelf software
- IT Infrastructure controls
Production Software Validation
Software in automated production and quality control systems drive computerized equipment to perform desired tasks, plus operator manuals and instructions.
The hardware system, software program, and general quality assurance system controls are essential to the automated manufacture of medical devices. The systematic validation of software and associated equipment will assure compliance with the QS regulation, reduce costs and improve quality. Proper validation smooths the integration of automated production and quality assurance equipment into manufacturing operations.
Examples of Production Software include:
- Automated Production Equipment
- Off the shelf or custom developed software
Electronic Records and Signatures
As computers have become pervasive in the workplace, so have electronic records. Most companies are unsure about electronic record keeping and the use of electronic signatures, often printing copies of these records to sign and send or retain. The cost of printing, transporting and storing hardcopy records is staggering – especially in information intensive business segments.
21 CFR Part 11 is a law that allows electronic records and signatures. Part 11 specifically allows any paper record to be replaced with an electronic record provided the supporting computer system and its operating features are properly validated. This allowance greatly increases the efficiency of individuals, reduces errors by identifying risk, and boosts overall accuracy and productivity. Engisystems can help you meet FDA 21 CFR Part 11 compliance requirements!
There are three primary areas of 21 CFR Part 11 compliance:
- SOPs - Approximately 10 SOPs are needed to address the IT infrastructure including Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures.
- System Features - More than 40 industry-standard features must be implemented and validated to ensure the computer system is secure, contains audit trails for data values, and ensures the integrity of electronic signatures.
- Computer System Validation - Every computer system must be documented to perform as intended while providing a detection or notification mechanism when not working properly. Validation must follow the company's SOPs, and virtually all companies find the risk-based approach to system validation is the most efficient, cost effective method available.
Engisystems performs part 11 validation services for computer systems and manufacturing equipment that incorporates records and signatures. Components of a Part 11 compliance solution may include:
- Electronic Records
- Controls for systems
- Signature manifestations
- Signature/record linking
- Electronic Signatures
- General requirements
- Electronic signatures and controls
- Controls for identification codes/passwords