Digitalization of Corporate Guidelines

Business Situation

The Corporate Quality Assurance department centrally ensures QUALITY across all the manufacturing sites of an organization. They keenly observe regulatory updates and observations to other organizations to stay in compliance. This department also checks QA department functioning at production sites. One of the most important tasks is to bring harmonisation in the organization. There comes importance of Corporate quality assurance guidelines.

What is Corporate Guideline?

Corporate Guideline are the inhouse guidance document to achieve global quality standards and harmonization in quality practices at all the locations of an organization.

Digitalization of Corporate Guidelines
Why Corporate Quality Assurance Guidelines?

The organizations are catering their products to different markets and there are various guidelines to be followed to sustain in front of regulatory bodies. Hence, based on guidelines from various regulatory bodies, an inhouse guidance document is prepared and is implemented at all the production sites for better compliance.

Business Complexity

When Corporate Guidelines are prepared manually, it is exceedingly difficult to circulate it across the sites. Further, training and tracking of implementation is also a very tedious task. Once the Guideline is made effective, implementation of subsequent revisions also need the same efforts.

CQA need to take continuous follow-ups from every site to ensure implementation of Corporate Guidelines.

Storage and retrieval system also need to be maintained for these documents. Maintaining index for list of guidelines with effective date, periodic revision due date and their version details is also an added task.

Soft copy of the document also needs to be retrieved with controlled access as a part of regulatory requirement.

Solution

We have digitalized the entire life cycle of the Corporate Guidelines i.e., preparation, review, approval, training, and distribution at multiple locations. System provides email notifications to stakeholders for all the activities as per predefined scheduled. All the soft copies of documents are kept by system in its repository. Same is provided to the user for revision based on access control with proper audit trail. Signatures of author, reviewer and approver is captured electronically through user authentication. Index of all the documents is readily maintained by the system. Even the distribution, retrieval of controlled copies and all other activities are audit trailed as per compliance.

Benefits

  • Seamless review and approval procedure
  • Improved Regulatory compliance
  • Easier Electronically controlled distribution and retrieval
  • Automated email follow-ups and reminders
  • Increased productivity
  • All time ready Index for CG
  • Controlled soft copy management better compliance
  • Reduced Storage space
  • Better back-up and disaster recovery

Start your digital journey today and meet our consultants to know how quality management for your clinical research organisations can be automated and made beneficial to you. Drop us an email at sarjen@sarjen.com or contact us to book a demo.