Quality management software for Pharmaceutical
Every aspect of the pharmaceutical manufacturing process must be controlled and monitored as per GxP requirements. In order to ensure the integrity of the enterprise and to maintain quality assurance, the implementation of standards such as ISO 9000 must be pursued. This means installing efficiently designed processes throughout the operation from product development, to supply chain and shipping. By adopting a strong, process-centric culture, your company can smoothly transition from chaotic and ad hoc management systems to a smooth running operation that will increase profits.
Good Pharmaceutical Manufacturing Practices
We understand that the requirements placed on pharmaceutical companies in terms of compliance are very high and that GxP is an essential part of that program. By using our solutions, your company gains the accountability and consistency that will give you a cutting edge over your competition. Our tools ensure full visibility from end-to-end, all the way from the creation and amendment of a regulation to the approval and revision of the content through to the update and retraining of employees for standard operating procedures (SOPs). We see the full lifecycle management as moving parts of a complete ecosystem and that’s why are unique approach that combines regulatory requirements, documents, processes, work instructions, and governance.
Our approach can help with all regulations and compliances related to pharma production and medical devices (GxP, CFR, GCP, GLP, GMP, HIPAA, ISO9001, medical devices regulations, SOX, BITS, CSA, FDA, FedRAMP, FIPS, FISMA, MHRA, NISP DoD, PCI DSS, SOC 2, U.S. SEC 17a-4 among others).
Manage the individual pieces of information, assign owners, and ensure governance through approval cycles, and change requests.
We fully support digital signature to ensure that the audit trail of all content is secure, time-stamped, with accurate and complete copies of records available for inspection throughout the retention period.
Full visibility to understand where records are used and their applicability. You can also maintain digital content with clear accountability, including roles and responsibilities.
Conduct Impact Analysis
Analyze your records for downstream impacts, and analyze the potential impacts on policies, SOPs, business units and related records.
Generate complete customizable output of processes and related records such as regulations in a ready-to-print and exportable Word format. You no longer need to manage SOP on paper! The digital SOP is in-sync all the time.
Approval and Governance Workflow
Integrated and embedded approval workflows to ensure strict control over the change of your records, including validation of changes, evaluation of impacts and highlighting changes.
By uniting goals and creating a common framework for your teams, they will be able to cooperate strategically, create change requests, and assign tasks to implementers.
Discover how we helped other companies succeed
Try It Now For Free!
Regulatory compliance, document management, process, digital standard operating procedures (SOPs), improve, standardize, and monitor your digital quality program with Interfacing’s Quality Management Software (QMS Software) the Enterprise Process Center®!