The first step to ensure compliance with the informatized systems regulations is to identify the systems with an impact on the GxP and to know its situation face to the regulations.
Qualipharma has the know-how and the experience needed to fulfill a complete evaluation of your systems, to identify the differences and detect the gaps according to the standards and regulations and to define the action plan to correct the errors detected.
This evaluation must contemplate the systems, its operational and documentary environments and every related process. While undertaking the evaluation many aspects should be considered:
- General policy and procedures related with the system management: SDLC, logical and physical computer security solutions, backup copy and restore, contingency plans, etc
- Processes affected or related by and with the system
- System validation status, including comprehensive review of the validation dossier
- Usage procedure, administration, backup copy, etc. of every system
- Controls, deviations and CAPAs (Corrective and Preventive Actions) related with the systems
- User´s Training
- Relationship with services and solution suppliers
Once the complete review of the systems is done, the identified gaps and corrective measures are classified depending on their impact on the final product quality, the patient safety and the information; its impact on the deficiencies detecting in case of audits it is also taken into account.
Correction or improvement plan is defined according to the rationalization of the client effort and the process and operations standardizations, developing actions and company policies which enable the maintenance of the IT Quality System and the system validation status.
Qualipharma offers support on the action plan execution and project management.
- Deep knowledge about the different company areas and processes affected by the computerized systems implementation
- Deep knowledge about standards, regulations and practices related to the IT systems
- Team experienced on procedures and quality systems integration
- Proved experience on optimize costs and effort during the action plan implementation