NextDocs is a provider of document, quality and compliance management software for companies operating in the FDA regulated industries. Using 21 CFR Part 11, components of Good Automated Manufacturing Practice (GaMP), and International Organization for Standardization (ISO 9001:2008), NextDocs has modeled its standards for quality and compliance based on the requirements yielded in industry standards. Solutions offered by NextDocs are also compliant with global regulations and guidance(s) such as ICH Q9+Q10 on Risk Management and Quality, and the ICH version of GAMP.
The FDA regulation 21 CFR Part 11 applies when using a computer system to create, maintain, retrieve, modify, transmit, or store an electronic representation of any information or process that is regulated by the FDA. With this specific industry requirement, NextDocs products are designed to be compliant with 21 CFR Part 11.
NextDocs commercial applications provide closed system technology solutions when the applications are set up in accordance with customers Standard Operating Procedures, which enable control of system access to be managed by authorized personnel.
NextDocs applications and systems are designed according to the following regulatory controls criteria:
- The system is developed and tested iteratively
- Auditable records can be generated
- Any record can be readily retrieved
- Only authorized access to records is permitted
- Appropriate audit trails are generated, retained, and auditable
- Proper operational sequences are followed
- Only authorized processing is permitted
- Only qualified individuals are involved in the respective processes
- Appropriate policies are developed regarding individual accountability for electronic signatures
- Documentation is controlled.
In addition to systematic security, GaMP and ISO regulations require that procedures be in place to perform a risk analysis based on the evaluation of potential gaps in customer requirements and industry requirements for software development. Once this analysis identifies potential risks, it is required that the automated system be validated and documented accordingly.
All applications developed by NextDocs meet the following requirements:
- Validated for accuracy and reliability and shown to be consistent with intended performance
- Can generate complete and accurate copies of records in both human readable and electronic form
- Archive records to ensure their accurate and ready retrieval
- Protected so that access is limited to authorized users
- Maintains audit trails that keep a complete time and date stamped record of all changes
- Uses operational checks to ensure proper process
- Uses authority checks to ensure that only authorized individuals can enter sign and/or change data.
NextDocs-developed technology supports an electronic signature that is a "computer compilation" a specific individual has authorized as "legally binding". NextDocs supports controls designed to ensure:
- Each identification code / password combination is unique
- Identification code / password combinations do not become obsolete
- Lost, stolen, missing, or otherwise compromised objects containing identification codes / passwords (e.g., identification cards) are properly deactivated/disposed off
- Adequate measures are employed to prevent unauthorized use of passwords and/or identification codes, and to detect and report such use immediately
- Initial and periodic testing of all objects containing identification codes / passwords (e.g., identification cards) to ensure continued proper functionality.
On the organizational level NextDocs engages in the following processes:
- A comprehensive internal audit process where quality and compliance is measured by the nature of NextDocs business activities as well as the extent and frequency of changes in regulatory requirements, business practices, and software development methods.
- An effective quality and compliance program in education and training, where expectations of our standards for conducting business are clear and communicated effectively.
- NextDocs controls records to provide evidence of conformity to industry standards and requirements, while producing results that measure the effectiveness of our operational procedures.
- We are committed in our prompt response and action to any potential gaps in our policies, practices or internal controls.
- Quality and compliance are held at the highest standard for our continued operation as a provider of innovative technology solutions for FDA regulated industries.
NextDocs software enables companies to meet numerous industry-specific regulations. Customers can control processes, ensure security, audit trail data, reduce risk and ensure compliance. Our solutions are highly adaptable to a variety of FDA and ISO regulatory directives and compliance standards, including FDA21 CFR Part 11, ISO 9001, ISO 14001, ISO 14064, OS HAS 18001.
A critical goal of NextDocs is to ensure that customers are able to achieve regulatory compliance throughout the use of our products. Quality and regulatory compliance are achieved through a variety of means, including:
- Robust, mature, quality management system governing the NextDocs product software development lifecycle, services delivery and IT infrastructure hosting services
- Rigorous program of internal and supplier audits to ensure process compliance throughout
- Quality System documentation providing evidence of compliance to U.S. and global regulations
- Proactively monitoring and commenting on regulations/guidelines