Description
Over the past few years, many regulatory agencies have determined that electronic data is more secure than “paper” documentation and less likely to be manipulated over the phases of a product’s development lifecycle. Printed documentation is no longer considered an exact and complete record since it doesn’t represent the raw data and metadata agencies are looking for. But that doesn’t mean electronic lab data is perfect: It must comply with a number of other stringent regulations, including the US’s 21 CFR Part 11 and the EU’s EDQM Annex 11. The current Good Manufacturing Practice (cGMP) guidelines are an essential tool for laboratories to follow and direct compliance to access controls, lack of permissions, audit trails, backups, and disaster recovery procedures – all of which better enable you to comply with regulators’ expectations for data integrity. OneSource works with you to assess your data integrity governance program and compliance to ALCOA by reviewing documentation and understanding laboratory systems configurations. From an assessment, a corrective action plan is proposed to give you the roadmap to regaining full compliance in your laboratory. This may include CSV updates or revalidations, and the creation of necessary documentation to satisfy regulatory requirements. This assessment instills the confidence of compliance and keeps your staff and lab inspection ready. Scalable services include: Assessment of systems, documents, policies, and environments Plans of corrective action Remediation and effectiveness checking Re-validation of impacted systems Analytical method requirements that span the full lifecycle — from method development and method transfer to method validation services — can be time-consuming activities. Leverage the OneSource team to streamline lab workflows and boost scientific productivity with data integrity assessment and methods to establish quality control procedures that support reliable research data. Services include: Method validation with accordance to USP and ICH Q2 Metrology and calibration
