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SmartSolve: Your Platform for Compliance

The SmartSolve® platform has been purpose-built for the Life Sciences industries. Our SmartSolve platform acts as a framework for your quality management application modules and offers a number of reusable functions. Platform benefits range from electronic signatures and audit trails to functional synergies between quality processes. Centralized repositories enable true enterprise management, and tools for ongoing management of SmartSolve applications reduce support costs as your business evolves. SmartSolve simplifies the process of moving your quality management software from development, to validation, to production environments with its single-click import/export capabilities.

Validation

  • Included Installation Qualification (IQ) and Operation Qualification (OQ) scripts pre-verified for accuracy prior to release.
  • IQ and OQ validation scripts included with SmartSolve solutions significantly reduce the time you need to prepare for and validate your system. 
  • With SmartSolve in the cloud, Pilgrim performs the software IQ and OQ activities on your behalf.

21 CFR Part 11 Compliance

Our SmartSolve Platform was built to meet the needs of life sciences organizations like yours who must comply with strict government regulations, including 21 CFR Part 11.

  • Meets the strict standards around electronic records, electronic signatures.
  • Audit trails keep detailed records of system, data, and process changes to support internal and external audits and to perform root-cause analysis.
  • Pilgrim continually monitors current opinions of the FDA and incorporates updates to ensure continued compliance with these requirements.

Cross-module Integration

The rich capabilities built within SmartSolve combined with deep integration across modules distinguishes SmartSolve from other vendors' patchwork solutions.

  • All of the core enterprise quality management applications you need are on a shared, common platform.
  • Solution modules are pre-integrated to share data in both directions in a manner unmatched by other solutions in the market. For example, changes to SOPs in your documentation module spur notifications to employee training activities and an audit finding recorded in your audit module can escalate to a corrective and preventive action (CAPA).

 

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