QA Program - Document Control

Our document control program at CompuChem encompasses all written documents, including SOPs, Quality Plans, laboratory logbooks, and all data deliverables. This program has passed numerous federal and state government inspections and examinations by commercial clients. The control of data deliverables consists of electronic and hardcopy data custody procedures and documentation. Our document control program is a complete system; we have specific procedures for producing, distributing, completing, and archiving all technical documentation.

The control of all other written records, including SOPs, Quality Manuals, personnel qualification records, computer and safety manuals, and laboratory logbooks, is enforced and managed by the QA Department.

The document control systems in place at CompuChem include:

• Electronic and hardcopy training documentation system
• LogTrax laboratory logbook tracking system
• Employee orientation documentation system
• SOP documentation and archival systems
• Quality Manual revision and distribution system

At CompuChem we take pride not only in the quality of our documentation, but also in the systems we have built to protect and enhance that quality.

CompuChem maintains Standard Operating Procedures (SOPs) that accurately reflect laboratory activities such as assessing data integrity, corrective actions, handling customer complaints, and all test methods. Procedures for test methods describing how the analyses are performed are specified in analytical SOPs and include sample preparation, cleanup and analysis. These are based on referenced methods published primarily by the EPA. Internally developed methods will be validated according to the EPA Performance-Based Measurement System. Controlled copies of SOPs are accessible to all personnel in each laboratory area as well as on CompuChem's internal network. Each SOP indicates the effective date, revision number, and signatures of the person who initiates the revision and those who approve the revision.
SOPs are useful in training staff, in ensuring consistency among staff, and in saving time and effort. Any deviation from an established procedure during an analysis is documented.

The QA Specialist has primary responsibility for document and distribution control of over 100 logbooks used in the laboratory. To ensure document uniformity and compliance with NELAC standards, the U.S. EPA, good laboratory practices, and other certifying agency protocols, specific document control procedures are used for all laboratory logbooks, runlogs, and worksheets.

Records Retention and Purging

Archived logbooks and laboratory records are stored on site for a period of five years. Logbook purging is recorded in the Archived Logbook Purge Log.