Helping you to win your compliance battles

Computer System Validation

Ensuring that your computerized systems are compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures and Eudralex Annex 11 We have expertise utilizing the Good Automated Manufacturing Practice (GAMP 5) guidelines and ASTM E2500 for the implementation of a risk based approach to Computerized System Validation..

Victory Compliance Group professionals can support you in the implementation, project management, equipment selection, commissioning and qualification of your computerised systems including:

  • Distributed Control Systems (DCS)
  • Supervisory Control and Data Acquisition (SCADA) systems
  • Programmable Logic Controller (PLC) based systems
  • Building Management Systems (BMS)
  • Environmental Monitoring Systems (EMS)
  • Laboratory Information Management Systems (LIMS)
  • Implementation and qualification of Track & Trace / serialisation of packaged pharmaceutical products

Data Integrity

Data integrity deficiencies will impact regulated organizations which could result in significant financial implications as well as lost reputations.

The FDA utilizes the ALCOA (attributable, legible, contemporaneous, original and accurate)

ALCOA Term Criteria Definition
A Attributable Who performed the action and when? If a record is changed, who did it and why? Linked to the source data.
L Legible Data must be recorded permanently in a durable media and be readable.
C Contemporaneous The data should be recorded at the time the activity is performed and date and time stamps should follow in order.
O Original The information must be the original copy or a certified true copy.
A Accurate No entries or editing performed without documented amendments

For new systems building ALCOA into the design specifications to ensure that the system will meet the Data Integrity requirements reduces the overall risk of non-compliance and failure. A collaborative approach with the system / equipment suppliers to implement suitable risk management, design reviews, change control, verification and acceptance testing is key to achieving robust computerized systems which meet the regulatory expectations for Data Integrity.

For legacy systems, a different approach is required:.

  • GAP Analysis review of the system to identify areas of non-compliance.
  • Remediation of the system GAP’s; this is ideally made through control system software and / or hardware upgrades with robust test plans to verify the system functionality.
  • Where systems cannot be upgraded and in certain circumstances interim manual controls can be implemented to provide a level of data integrity assurance; however permanent automated solutions should be implemented.

Victory Compliance Group help our customers to achieve Data Integrity compliance by offering the following services:.

  • Legacy System Data Integrity Compliance Reviews.
  • Risk Management Implementation.
  • Interim Controls Implementation.
  • Data Governance Policy Implementation.
  • System Verification and Validation Documentation and Execution.
  • Data Integrity Inspection Readiness.
  • Design Specification Services.
  • Data Integrity Reviews.