Applitech offers the full set of validation services that pharma, biotech, medical device, and diagnostic manufacturers need across their facility, equipment, and computerized system lifecycle. Engagements range from gap analyses through master planning, audit support, protocol preparation and execution, and continuous revalidation programs.
21 CFR Part 11 compliance
21 CFR Part 11, the FDA's requirements for electronic records and electronic signatures, remains a challenging compliance issue for regulated industry. Applitech helps you understand and implement a risk-based approach rooted in the FDA's Final Guidance for Scope and Application. From initial gap analyses and remediation planning for existing systems through prospective assessments of new systems, the team determines Part 11 relevance and associated requirements for compliance.
Validation program management and master planning
- 01Validation project managers with training and proven delivery records
- 02Validation Master Plan creation or improvement
- 03Familiarity with the ever-changing regulatory environment
- 04Schedule and budget discipline without sacrificing quality
Training and audit preparedness
cGMP training and audit preparedness covers both new and refresher courses on current GMPs, with practical training on how to interact with regulatory authorities. Auditors with FDA and MCA experience perform mock audits and surface issues with cost-effective remediation paths.
Protocol preparation and execution
- 01IQ, OQ, and PQ protocol preparation in your templates or ours
- 02Protocol execution by trained validation staff
- 03Experience in computer validation, equipment qualification, SIP, and CIP
- 04Report preparation, even when execution was performed by others
- 05Commissioning and start-up support across the new facility lifecycle
Continuing validation and computer validation
Applitech operates revalidation programs to maintain a constant state of validation compliance on essential equipment. The Computer Software Validation (CSV) group delivers CSV expertise from localized control systems through corporate enterprise systems, and reduces total CSV cost by engaging during design rather than only after build.
- 01Programmable Logic Controllers (PLCs)
- 02Supervisory Control and Data Acquisition (SCADA)
- 03Temperature, pressure, and other field instruments
- 04Control panel validation
- 05Automation systems for temperature, humidity, and access control
- 06Laboratory Information Management Systems (LIMS)
- 07Building Management Systems (BMS)
- 08Barcode, material handling, vision inspection, and process monitoring
Application and bus technology coverage
- 01Applications: DeltaV, Wonderware, iFix, Rockwell, mySAP, PeopleSoft, Oracle, POMS, Documentum
- 02Bus technologies: ASi, Profibus, DeviceNet, Foundation Fieldbus