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.

SOP Quality Management: QEdge makes it easy to automate your SOP process and workflow with better time management and resource allocations. QEdge SOP management software offers a system to track SOPs and manage SOP life cycle that includes creation, review, approval and release along with distribution with unique distribution code and achieving. With every process flow, the associated access rights ensure the users to works on tasks defines for them for effective process control.

eLearning management software (lms) solution as a part of QEdge, is an excellent enterprise tool for learning management and continuous learning across the organization. The content for eLearning can be organized for multiple location, multiple department and access rights can be controlled and managed based on department and organization. eLearning management software (lms) is also backed with ability to assess the recipient with randomly generated quick from a larger question bank. The quiz can also be intelligently designed from multiple eLearning modules and questions are randomly picked up so two people taking assessment quiz at the same time, or the same person taking repeat quiz and get different set of questions.

Share and manage training data across the company. Training records management software is particularly useful for compliance in regulated markets especially in pharmaceuticals, biotechnology and healthcare domains. Each time SOP or Work Instruction is revised it automatically identifies which are end consumers and notify them as well as their training managers. Auto alert also get generated in case of periodic training is due such as GxP trainings for Pharmaceuticals and healthcare segment. As per pharmaceuticals and biotechnology industry requirements, the software is compliant to regulatory alignment including GMP, FDA 21 CFR part 11 and EU GMP Annex 11.

Better control of inspection & assessment: Auditing is a crucial job within a pharmaceutical company. The purpose of carrying out a GMP audit in the life sciences Industry is to verify compliance with the principles of Good Manufacturing Practices and to recommend any necessary corrective actions. The breaches identified in the audit check list help the management to review the quality system of Pharmaceutical and Biotech Companies. Audit Management software records processes electronically.