Product/Service

SOP Management

Source: NextDocs Corporation

Standard Operating Procedures (SOPs) are essential to all quality-related, GxP compliant processes as well as the ability to verify that employees are being trained on these SOPs appropriately.

Standard Operating Procedures (SOPs) are essential to all quality-related, GxP compliant processes as well as the ability to verify that employees are being trained on these SOPs appropriately. SOPs must be well organized, up-to-date, reviewed and approved in a defined schedule, and modified with documentation. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training.

Simple, Effective and Compliant SOP Software and Employee Training Management through the Entire Lifecycle.

The NextDocs SOP Management Software addressed these key challenges to deliver a compliant, user-friendly solution to manage Standard Operating Procedures and associated employee training records while minimizing the demands on your already overtaxed business and IT users.

It manages not only Standard Operating Procedures but also associated policies, work instructions and forms. The NextDocs easy to use interface allows organizations to create Training Plans for each employee based upon job roles and the relevant training items required to meet those job roles.

NextDocs SOP Management Software features and benefits

Features Benefits
Creation from controlled templates that automatically populate headers, footers and other fields from document metadata. Assists in standardization and ensures that key information such as document number is not accidentally left blank or carried over due to copying a previous document.
Flexible review processes that can use PDF annotation or MS Word tracked change processes Ability to enforce standard reviews; insight into who participated in reviews and their comments; ability for authors and reviewers to easily compare versions to see how reviews were handled.
Configurable approval processes that collect the signatures required by the company in the desired order Assurance that the correct processes have been followed for approval; detection of any change to a document made after one or more approvers have signed
21 CFR Part 11 compliant electronic signature Allows efficient use of the system across physical locations and eliminates costs associated with printing, couriering and storing paper documents.
Detailed audit trail Provides Part 11 compliance as well as insight into activities completed in the lifecycle of an SOP.
Flexible change control with configurable change request forms and review and approval processes Change control can be enforced for any desired combination of new document creation, document update and document retirement. Documents cannot be created or modified until required processes have been followed.
Flexible release to effectivity Documents can be made effective manually, on a scheduled date, or a set period of time after approval. Effective date is automatically recorded and stamped on the document.
Optional training stage Documents can be released for training purposes prior to becoming effective.
Ability to require specific training per major version of a document Each major version can require a quiz, Read & Understood certification, or no training at all. Users are not forced to re-train for documents updates involving only minor changes.
Role-based training Client-defined roles control which documents a user must complete training for.
Training Quizzes Training quizzes can be issued to test an employee’s comprehension of a document and its processes. Quizzes are scored automatically upon completion and results reported to training managers.
Monitoring of training records Training managers can easily monitor the status of training for a user, document, etc.
Periodic Review Documents can be scheduled for periodic review at company-defined intervals. Reminders are sent out before review is due and workflow can be initiated automatically or manually. If no change is needed, the periodic review date is re-calculated without versioning the document; otherwise, a change request is initiated.
Printing options Configurable options are available for controlled, uncontrolled and clear copy printing.
Efficient handling of supporting documentation Allows access to supporting materials to support decision-making and investigation without controlled document processing unless appropriate.