Sarjen Systems Pvt. Ltd. software

Effective change management for better control: QEdge Change control management is a step-by-step approach to manage documented, well traceable and compliant approach to changes that take place in a system or product or process in any industry. As rightly said, “Change” is inevitable, and it is important to have robust change management process across the organization for process performance and product quality and, of course, customer safety. It is not limited to any department and must be managed by every department of an organization.

Nonconformance detection & reporting system. Deviations management is a key role in assuring product Quality, Purity and Strength. Any non-compliance of an established GMP standard or of approved requirements, specifications and standard operating procedures (SOPs) needs to be identified, recorded and evaluated. Any critical or major deviation which affect the product quality, reliability of procedure or records should be investigated and resolved. Organizations can depend on the software for a complete audit trail that supports compliance with part 11 requirements. The system also supports e-signatures, data integrity, and data security for better compliance. The system supports integration with the Document Management System to help users easily access supporting documents, pre-saved templates and Standard Operating Procedures (SOPs) relevant for deviation management.

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, reports and approval. Protocol management is a part of document management system in pharmaceutical and life science industries. Any official procedure or system of rules need to be validated from a base. For our industry, the base is pharma regulatory. Any protocol needs to be compliant before it is validated and approved. Validation protocol must be written before carrying out a validation activity. Therefore, when an organisation is managing all documents, it is important that each document is synced with other documents like SOP’s, Controlled documents, work instructions and specifications.

Work Instructions are documents that clearly and precisely describe the correct way to perform certain tasks that may cause inconvenience or damage if not done in the established manner. These instructions are helpful in providing detailed specification tasks which are referenced in the procedure. They aid in trainings management and reduce mistakes because of step wise instruction process required to accomplish something missed from recorded procedures. This is where work instruction management is required.