- +91-821-983-3540
- 01762-503026
- info@pharmaffairs.in
Documentation & Records
With the competence in meeting industry standards and the prescribed compliances, we take the responsibility to aid pharmaceutical companies with the correct and accurate documentation and record services that are essential for them. We integrate and help you manage all the required documentation and records, enabling you to maintain transparency, traceability, and regulatory compliance during the entire product life cycle. We cover multiple areas under our services:
Documentation Development
We aid the pharmaceutical clients design and edit many types of complex documentation including but not limited to batch records, standard operating procedures (SOPs), protocols, reports, and every fundamental elements vital to attaining regulatory compliance and submissions.
Document Management System Implementation
We assist in the development and configuration of sophisticated document management systems (DMS) as per the requirements of the organization. This includes creating, reviewing, approving, distributing, and archiving documents while streamlining the processes to enhance efficiency with multi-levelled versioning and traceability of all documents during the operational lifecycle.
Records Management
We assist pharmaceutical companies with the organization, classification, archiving, and maintenance of important materials including but not limited to manufacturing records, laboratory data, quality control documents, and regulatory submissions. Such records are crucial and must be maintained with utmost integrity and security ensuring compliance with regulatory requirements and audit readiness.
Compliance and Training
We help in structuring documentation and records management training courses including principles of data integrity, good documentation practices (GDP), and other regulatory guidelines. With the implementation of these training courses, competency levels will be enhanced in order to mitigate risks, foster a culture of compliance, and eliminate errors within your organization.
Remediation and Gap Analysis
Our approach towards enhancing compliance and advancement is the identification of problematic areas followed by collaborative efforts towards elimination of any and all impediments while monitoring and controlling the fulfilment and integration of new strategies within the organization's personnel.